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COVID-19 DEW Report, powered by Reformulary®

Information about COVID-19 and the pharmaceutical industry’s response changes by the hour. Here at Reformulary Group, our mission is to help Canadians make sense of medicine, and in times of crisis that is especially important. Our website will update on Wednesday of each week with the past several days’ highlights of the medical community’s attempts to tackle COVID-19.

Please note many of these drugs and technologies are in very early stages of development and the regulatory process. The information below is compiled for reference and personal interest only. The information is not complete and may not be accurate. Reformulary Group does not offer commercial or medical advice on these emerging developments. You should do your own investigation and seek your own professional advice before making any commercial or medical decision relating to this information.

Highlights of the medical community's attempts to tackle COVID-19.

Updated each Wednesday.

Last Updated: October 28, 2020

Canada
International

Trudeau announces plan to purchase 76 million doses of Canadian-made COVID-19 vaccine

Canada has announced another commitment of COVID-19 vaccine doses, this time for the candidate being developed by Quebec-based Medicago and multinational GlaxoSmithKline. While still in pre-clinical studies, researchers are optimistic about the level of neutralizing antibodies observed following a single dose. The deal secures 76 million doses of the candidate if it receives regulatory approval. Canada has invested $173 million to assist Medicago with development and production capacity of the vaccine, and this deal represents the seventh commitment of vaccine candidates from various manufacturers should they receive regulatory approval.

Published: October 23, 2020

CBC

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A closer look at Canada’s homegrown COVID-19 vaccine candidates

CBC News has published a rundown of Canadian COVID-19 vaccine candidates currently under development. Most are preclinical or in very early stages.

Manufacturer/Researcher

Location

Vaccine Type

Stage

Entos Pharmaceuticals

Edmonton

DNA

Pre-clinical

IMV

Halifax

Protein subunit

Pre-clinical

Medicago

Quebec City

Virus Like Particle (VLP)

Phase 1 clinical study

Mediphage Bioceuticals/U of Waterloo

Toronto & Waterloo

DNA

Pre-clinical

University of Alberta

Edmonton

Protein subunit

Pre-clinical

University of Manitoba

Winnipeg

VLP, replicating viral vector

Pre-clinical

VIDO-Intervac

Saskatoon

Protein subunit

Pre-clinical

Western University

London, ON

Replicating viral vector

Pre-clinical

Published: October 19, 2020

CBC

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Canada to review Moderna’s COVID-19 vaccine candidate in real time

Health Canada will collect data from a late stage clinical trial of Moderna’s COVID-19 vaccine candidate in real time, a process that can expeditereviews of a drug compared to evaluating a larger quantity of data once a trial is complete in its entirety. The agency is doing the same with data from BioNTech/Pfizer’s candidate, as well as AstraZeneca’s. Moderna’s CEO recently indicated he expects their candidate to be in a position to seek Emergency Use Authorization (EUA) in the United States by late November, as documented in earlier COVID-19 DEW Reports.

Published: October 13, 2020

Reuters

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Canadian researchers begin clinical trials of tuberculosis vaccine for COVID-19

University Health Network researchers in Toronto are beginning a clinical trial of 3,600 front-line workers to determine if Bacillus Calmette–Guerin (BCG), a vaccine typically given against tuberculosis, can be sufficiently immune-boosting that it can decrease the frequency and severity of COVID-19 among participants. The concept for the trial emerged when researchers noted that some jurisdictions with high BCG vaccination rates also had lower COVID-19 infection rates. Similar trials are being conducted internationally in Australia, Europe and Mexico. While the vaccine does not offer immunization against COVID-19, its immune-boosting effect could potentially become another tool, similar to masking and physical distancing, that protects vulnerable populations.

Published: October 6, 2020

CTV News

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Health Canada approves first rapid antigen COVID-19 test

Health Canada has approved the Panbio COVID-19 Ag Rapid Test Device manufactured by US-based Abbott Laboratories, which can give results in fewer than 20 minutes. It is the first rapid antigen test approved in Canada, amidst political pressure for more widespread testing options. The test is considered suitable for point-of-care use, meaning it can be administered by trained professionals in pharmacies, doctors offices and other settings, and doesn’t require the use of a lab to generate results. The antigen test is considered less accurate than the current testing process used across Canada.

Published: October 6, 2020

CBC

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U of A researchers discover new way remdesivir acts against virus that causes COVID-19

University of Alberta researchers have discovered an additional mechanism by which antiviral drug remdesivir helps counter COVID-19 infections. The team had previously established that remdesivir can inhibit the virus from self-replicating, but U of A researchers have found that the drug’s other mechanism may stop or delay the virus from spreading within the body. Generally, antivirals only work in one specific way. Remdesivir has received conditional approval for use in Canada on patients with severe COVID-19 symptoms. It has been shown to speed up recovery times in COVID-19 patients.

Published: September 25, 2020

CBC

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Trudeau announces purchase of 20 million doses of Oxford University COVID-19 vaccine

Canada has made an additional pre-purchase of COVID-19 vaccine doses, this time securing 20 million doses from Oxford University’s candidate. It is widely seen as one of the most promising candidates currently in phase 3 trial and is being manufactured by AstraZeneca. Canada has now obtained commitments for more than 150 million doses across six different manufacturers, although delivery of the vaccines is contingent on success in human clinical trials and regulatory approval.

Published: September 25, 2020

National Post

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Canada signs deal with VBI vaccines to develop coronavirus vaccine candidate by 2022

Canada has secured an additional commitment for COVID-19 vaccines, this time from VBI Vaccines. The vaccine candidate, VBI-2900, will undergo human trials exclusively in Canada and the deal commits to complete vaccine development by the first quarter of 2022. The government has secured deals for COVID-19 vaccines from several companies, documented in earlier COVID DEW Reports, pending regulatory approval of the candidates.

Published: September 21, 2020

Global News

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Convalescent blood plasma trial expands to Saskatchewan

A study evaluating the effect of using convalescent plasma to treat severe COVID-19 patients now includes 50 hospital sites across Canada, with enrolment of 112 participants since it began in May. This past week saw the first Saskatchewan patient enrolled in the CONCOR-1 trial. Convalescent plasma, obtained from the blood of patients who have recovered from COVID-19, contains antibodies against the virus. Canadians who have recovered from a COVID-19 infection are encouraged to contact their local blood service to see if a donation of their blood can contribute to the study.

Published: September 18, 2020

CTV News

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Feds sign deals with Novavax and Johnson & Johnson to secure millions of vaccine doses

The federal government has signed deals with Novavax and Johnson & Johnson to deliver a COVID-19 vaccine should their candidates receive regulatory approval, increasing the number of doses committed to Canada to 88 million with the potential for tens of million in addition. This follows earlier agreements with Pfizer and Moderna to obtain their vaccines if it approved. Based on current timelines for Phase 3 trials, vaccine deliveries to Canada could begin in early 2021; however the government has stressed that regulatory approval is the most important step.

Published: August 31, 2020

CTV News

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Made-in-Canada COVID-19 vaccine effort slowed by manufacturing delay

A promising vaccine candidate from the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac), which has been documented in earlier COVID-19 DEW Reports, is encountering delays in proceeding to advanced trials. Researchers cite a lack of domestic manufacturing capacity as preventing them from obtaining the high grade materials needed for further study before clinical trials in humans can begin.

Published: August 23, 2020

CBC News

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Ontario mining company 1st to try new mobile test that diagnoses COVID-19 in as little as an hour

A Northern Ontario mining company is the first to deploy a portable, on-site COVID-19 test that the company administers itself and receives results within an hour. The test is being imported by Guelph’s Precision Biomonitoring and is being used at New Gold Inc.’s Rainy River site. It uses a freeze-dried reagent to analyze results taken from the type of nasal swab typical of other COVID-19 tests, without needing refrigeration that makes other forms of mobile testing challenging. Up to 9 tests can be processed at once and results are tracked via a smartphone app.

Published: August 11, 2020

CBC News

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Canada inks deal with Pfizer, Moderna for coronavirus vaccine candidates

Canada has secured its first commitment of a COVID-19 vaccine delivery, signing deals with Pfizer and Moderna to deliver “millions” of shots should Health Canada approve the vaccines for use in Canada. The government is not revealing the exact number of shots purchased, citing on-going negotiations with other manufacturers. Both Pfizer and Moderna have vaccine candidates undergoing late-stage clinical trials in the United States.

Published: August 5, 2020

Global News

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Saskatchewan vaccine developer locks in Canadian manufacturers for human clinical trials

The University of Saskatchewan's VIDO-InterVac has signed deals with two Canadian manufacturers to produce its promising COVID-19 candidate on a scale suitable for human trials. The candidate, which has been documented in earlier COVID-19 DEW Reports, uses a modified version of the spike protein (the mechanism by which the virus attaches to human cells) responsible for COVID-19 to stimulate an immune response. Toronto-based Dalton Pharma Services will be manufacturing the adjuvant, part of the vaccine that works alongside the spike protein to trigger a broader immune response, while Montreal’s Biodextris will be producing the antigen, which is a component of the spike protein.

Published: July 29, 2020

Yahoo News

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Health Canada makes Gilead’s remdesivir first drug approved for COVID-19 treatment

Health Canada’s expedited review of Gilead Science’s remdesivir (brand name VEKLURY) has resulted in it being approved as the first drug to treat COVID-19 in Canada. The antiviral drug has shown evidence that it can reduce the length and severity of COVID-19 in infected patients, particularly in moderate to severe cases in hospitalized individuals. It has not yet been proven that remdesivir can improve outcomes in mild cases or reduce mortality. The approval applies to adults, as well as children 12 years and older who weigh at least 40 kilograms.

Published: July 28, 2020

iPolitics

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Canadian-led study to examine antibodies from recovered COVID-19 patients as treatment for others

A study led by Canadian researchers is recruiting 1,200 participants from Ontario and New York to determine whether blood plasma from recovered COVID-19 patients can help those fighting an active infection. The Lawson Health Research Institute, which partners with the University of Western Ontario and St. Joseph’s Hospital, is working with Canadian Blood Services to coordinate patient matching. The study seeks to determine if plasma treatment can reduce intubation and mortality rates after 30 days. Those seeking to donate plasma must be 67 years or younger, have fully recovered from COVID-19, and be symptom-free for at least 28 days, while to be eligible to receive plasma a patient must be 16 or older, require oxygen, sick for fewer than 12 days, and have plasma that is compatible with donor plasma.

Published: July 22, 2020

Global News

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University of Lethbridge researchers work to find COVID-19 treatment

Researchers at the University of Lethbridge have undertaken a project to develop a treatment for COVID-19. The team will focus on disrupting the virus’s ability to replicate by targeting the interaction between viral proteins and their human host cell systems. Edmonton-based non-profit Applied Pharmaceutical Innovation (API) is partnering on the project, which has received $210,000 in funding from the organization Mitacs.

Published: July 20, 2020

Global News

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Study suggests 8 times more people in BC infected with virus than confirmed

A study in British Columbia that saw collaboration between the B.C. Centre for Disease Control, University of British Columbia, LifeLabs and public health scientists found that blood test results suggest cases in Vancouver could have been 8 times as high as officially recorded. The project looked at anonymized blood test samples collected for reasons unrelated to COVID-19 in March and May and found a prevalence of 0.28% in the March samples, and 0.55% in the May batch. While this suggests case counts higher than reported, it also means an overall prevalence of under 1%, suggesting successful suppression of community spread. The study is significant as it is the first of its kind in Canada, but officials plan to use serological testing on a large scale to track the disease, as has been documented in earlier COVID-19 DEW Reports.

Published: July 15, 2020

CTV News

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The hunt for a vaccine: Canadian company begins human testing of COVID-19 candidate

Quebec City-based Medicago has begun trials of its COVID-19 vaccine candidate. The vaccine is plant-based and uses virus like particles (VLP) to mimic the virus and trigger an immune response, unlike many traditional vaccine candidates which use animal products or live viruses. Plant-based vaccines can be produced faster, and in much larger quantities, than traditional ones. 180 participants, aged 18-55, will receive two doses 21 days apart, with safety and efficacy findings expected to be available in October. The shot is the second vaccine candidate authorized for human trials in Canada, the other is made by CanSino.

Published: July 14, 2020

CTV News

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GSK to develop plant-based COVID vaccine with Canada’s Medicago

Global drug behemoth GlaxoSmithKline (GSK) is partnering with Quebec City-based Medicago to develop a COVID-19 vaccine candidate. GSK has contributed its adjuvant technology (efficacy boosters) to multiple initiatives around the world in hopes of finding a successful candidate. The partnership with Medicago uses plant-based technology, unlike GSK’s other global projects.

Published: July 7, 2020

Cape Breton Post

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Canada starts COVID-19 salmon oil trial

A Norwegian company will be partnering with Canadian researchers to see if salmon oil can improve COVID-19 patient outcomes, specifically shortening patients’ time in the intensive care unit and reducing the number of patients requiring respiratory care. The phase 2 trial of 100 participants will focus on two at-risk groups: former smokers with lung complications, and asthma sufferers who are resistant to steroids. Some participants will receive standard of care while others will receive a pure salmon oil capsule, which has been shown in earlier trials to cushion airway inflammation in asthma patients. Researchers from Mount Sinai Hospital as well as KGK Science will collaborate on the project.

Published: July 2, 2020

Fish Farmer Magazine

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Quebec researchers already starting coronavirus studies after receiving grants

The Canadian Institutes of Health Research (CIHR) has provided $109 million in funding to 139 COVID-19 research projects across the country. Teams at Laval University in Quebec will focus on two initiatives: one will determine if blood thinning drugs can prevent the clotting that has been a cause of death in some COVID-19 patients, and another will examine using blood plasma from recovered COVID-19 patients to treat ill ones. In addition to the Laval projects, a large number of initiatives were funded at McMaster University as well as research in Montreal focusing on the role of vitamin D in fighting COVID-19, and the risk of re-infection for healthcare workers.

Published: June 26, 2020

Global News

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London, ON researchers the first to profile immune response to COVID-19

Researchers in London, Ontario have identified six cytokines that they believe can be targeted by therapies treating COVID-19. The team, working out of Lawson Health Research Institute and Western University, used blood samples from 30 participants to examine 57 cytokines that are common and critical to fighting infection. The six that have been identified have persistently high readings in COVID-19 patients, which be dangerous when they over-react to fighting infection and end up harming the body, as is often the case in severe COVID-19 patients.

Published: June 25, 2020

Global News

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Scientists aren't waiting around for governments to launch antibody testing

A number of initiatives are underway to identify and track Canadians’ immunity to COVID-19. A team at the Centre for Global Health Research at St. Michael’s Hospital has already distributed 3,500 antibody test kits in collaboration with polling firm Angus Reid, who is helping survey Canadians to identify those who may have had symptoms in March, April and May. Researchers hope to survey more than 10,000 people. Recipients prick their own blood and return it to the lab for analysis of antibody content. Meanwhile, the creator of the CANImmunize app, which allows Canadians to track their vaccine history and scheduling, is updating it to allow Canadians to track COVID-19 vaccinations, once they are available, or other forms of confirmed immunity that will enable some workplaces where physical distancing is more difficult to operate closer to normal.

Published: June 20, 2020

CBC News

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Canada buying 140,000 blood tests to begin immunity testing of COVID-19

The federal government will be undertaking serology testing to learn more about the spread of COVID-19 in Canada. The results will be used to track how widely the virus has spread, which populations will be most vulnerable to new outbreaks and help inform public policy in deciding which health measures to enforce and, if or when a second wave of COVID-19 is seen in Canada, who to vaccinate first once a shot is available. The information will come from purchasing 140,000 kits of a serology test from Abbott Laboratories.

Published: June 17, 2020

CTV News

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More hospitals part of plasma transfusion trial to treat COVID-19 with antibodies

There are some early encouraging signs from a Canadian clinical trial evaluating blood plasma transfusions, as the first two patients to receive treatment are improving. A female patient formerly in ICU, as well as a 78-year old male patient, are expected to recover after receiving blood plasma from people who have recovered from COVID-19. It is thought that the blood of recovered people contains antibodies helpful to fighting the disease. More than a dozen sites across Ontario and Quebec are ready to participate, with hopes to expand to 60 sites nationally to test transfusions in 800 participants against a control group of 400.

Published: May 28, 2020

CTV News

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Blood test coming soon for COVID-19 developed in Charlottetown lab

A Charlottetown-based company, Affinityimmuno, is working on two tests for COVID-19 that could seek Health Canada approval within months – one which tests for an active infection, and a serology test that can determine if a person has been previously exposed to the virus. The serology test is different from others currently approved in that it aims to determine whether the body can stop the virus from attaching inside of it, a distinction the company is hopeful can make the test more accurate.

Published: May 28, 2020

The Guardian

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Alberta pauses trial of hydroxychloroquine for COVID-19 treatment

Researchers in Alberta have paused a clinical trial of hydroxychloroquine, which has become high profile following a heated political discussion in the United States, after concerns were flagged by the medical journal The Lancet that the drug can cause heart problems and increase mortality. Similar trials have been paused in other locations, including one by the World Health Organization. The trial in Alberta, a collaboration between four different institutions, had enrolled 150 out of a targeted 1,600 participants.

Published: May 26, 2020

CBC News

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Coronavirus: Ontario announces funding for 15 research projects aimed at COVID-19

The Government of Ontario has announced $20 million in funding through the Ontario COVID-19 Rapid Research Fund towards 15 proposals. Projects focus on vaccine development, diagnostics and social sciences. One of the vaccine research projects, based at the University of Guelph, is trying to identify antibodies that can recognize the disease causing COVID-19 in mice and chickens and prevent its entry into their systems.

Published: May 21, 2020

Globe and Mail

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Appili receives Health Canada nod for favipiravir study

Appili Therapeutics has received Health Canada approval to initiate a clinical trial of the anti-influenza drug favipiravir, which is authorized for use in Japan as AVIGAN®. The trial will use donated supplies of the drug from manufacturer FUJIFILM Toyoma Chemicals (FFTC) to conduct a phase 2 trial based out of long-term care homes in Ontario to collect data on the drug’s efficacy and safety in a population group among the most vulnerable to COVID-19. With support from researchers with the University of Toronto, Sunnybrook Health Sciences Centre and Unity Health Toronto the study will analyze a 25-day course of the drug against placebo in approximately 760 participants.

Published: May 21, 2020

Stock Watch

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Scientists at Nova Scotia lab closer to testing COVID-19 vaccine on humans

A Halifax-based company, IMV, is making progress with a COVID-19 candidate that has undergone animal trials and could see a human trial of up to 84 participants as soon as the summer. The project is being overseen by the Halifax-based Canadian Centre for Vaccinology, on the heels of separate approval for the first clinical trial of a COVID-19 vaccine in Canada from that facility.

Published: May 21, 2020

Globe and Mail

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Canadian team treating COVID-19 patients with dialysis sees 'very positive' early signs

Researchers in London, Ontario are seeing some encouraging signs in COVID-19 patients treated with a form of dialysis that removes, alters, and then re-enters into the body white blood cells that are better equipped to fight the inflammation that characterizes severe cases. Forty patients are under observation, with half receiving the dialysis treatment and half receiving standard care.

Published: May 20, 2020

CTV News

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Canada’s first COVID-19 vaccine trials approved for Halifax university

The first clinical trials of a COVID-19 vaccine candidate in Canada will take place under the watch of a Halifax-based research team, in conjunction with a Chinese manufacturer. The Canadian Centre for Vaccinology (CCfV) at Dalhousie University will administer the trial of the candidate known as Ad5-nCoV, which expresses a COVID-19 antigen that researchers hope can result in the development of antibodies that will prevent infection from the disease. Upon receiving approval from an ethics board the trial will begin with 100 healthy participants aged 18-55 and, pending acceptable safety outcomes in that group, be expanded to an additional 500 participants anywhere from 18 to 85 years of age.

Published: May 16, 2020

CBC News

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Saskatoon medical cannabis company making potential COVID-19 vaccine components

A Saskatoon-based medical cannabis company, Zyus Life Sciences, is working with the Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac) to develop a COVID-19 antigen in plants that can subsequently be used in the development of a vaccine against the disease. While cannabis plants will not actually be used, other plants will be used based on technology the company has employed in its medical cannabis business. There are a number of potential advantages to creating an antigen in a plant, primarily the ability to rapidly scale up production through cloning should the antigen prove useful in developing a successful vaccine.

Published: May 14, 2020

Globe and Mail

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Health Canada approves first test to detect antibodies for COVID-19

Health Canada has approved a serological test in use in the United States since April. The test, DiaSorin’s LIAISON®, will detect antibodies signalling that a person has been exposed to COVID-19 and may have some degree of immunity to it. The product joins 18 other approved COVID-19-related tests authorized for use in Canada, most of which test for active infections.

Published: May 12, 2020

CTV News

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Appili Therapeutics submits CTA with Health Canada to sponsor phase 2 clinical trial evaluating favipiravir

A Halifax-based biopharmaceutical company has applied to Health Canada to initiate a clinical trial of anti-influenza drug favipiravir, which is authorized for use in Japan as AVIGAN®. Appili Therapeutics plans to use donated supplies of the drug from manufacturer FUJIFILM Toyoma Chemicals (FFTC) to conduct a phase 2 trial based out of long-term care homes in Ontario to collect data on the drug’s effectiveness and safety in a population group among the most vulnerable to COVID-19.

Published: May 11, 2020

Financial Post

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One of Canada’s vaccine hopefuls has shown promise in ferrets, so now what?

A promising COVID-19 vaccine candidate out of the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre, documented in an earlier edition of the COVID-19 DEW, is awaiting results from a trial using ferrets, a weasel-like animal with a respiratory system similar to humans. There have been some early encouraging signs in the animals, such as higher levels of antibodies. Results are expected for the end of May and if they are successful clinical trials in humans could follow. The lab has received significant support from the Government of Canada in its efforts to develop a successful vaccine, totaling about $23 million in funding.

Published: May 11, 2020

iPolitics

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World’s first COVID-19 dialysis treatment comes from Canadian research team, doctors say

A research team in London, Ontario is proceeding with a 40 participant trial of a dialysis method to treat severe COVID-19 patients following success in one critically ill patient. The process involves “reprogramming” white blood cells in blood that’s cycled outside of the body in order to make them more effective at fighting inflammation, similar to how traditional dialysis filters blood for people with kidney conditions. The one patient who received the treatment thus far has seen their chance of death decrease from 98% to 30%.

Published: May 7, 2020

CTV News

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Laurent Pharmaceuticals receives Health Canada’s approval to initiate COVID-19 clinical trial

A Montreal-based pharmaceutical company will soon begin a phase 2 trial of a drug known as LAU-7b to determine its suitability to treat COVID-19. The trial, named RESOLUTION, will be placebo-controlled and investigate whether the drug can reduce the severity of the disease by stimulating the resolution phase of inflammation, a natural process towards the end of the inflammatory response cycle. Approximately 200 hospitalized patients will be enrolled across multiple sites in Canada and receive a 14-day course of the oral drug.

Published: May 6, 2020

Calgary Herald

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AbCellera receives $175.6 million from the Government of Canada to discover solutions for COVID-19 and build a manufacturing facility for antibody drugs

Vancouver-based AbCellera has received a $175.6 million commitment from the federal government for its research on COVID-19 antibodies in recovered patients for use in drugs to prevent and treat the disease. The company has discovered more than 500 unique human anti-SARS-CoV-2 antibodies since late February working in partnership with the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases, part of the United States National Institute of Health (NIH). The research will be used to develop drugs to treat the current outbreak, look at potential antibody tests to determine immunity in people, and to prepare for future pandemic outbreaks. The funding, which comes from the government’s Strategic Innovation Fund (SIF) will be used to further antibody research and later develop a manufacturing facility.

Published: May 3, 2020

Financial Post

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Health Canada pauses regulatory approval for COVID-19 rapid test

A rapid results test for COVID-19 made by an Ottawa-based company that was expected to be a major supplier of governments across Canada has been restricted to lab use only following Health Canada concerns about the accuracy of its results. The manufacturer, Spartan Bioscience, has voluntarily recalled 5,500 units and says it will work to correct the concerns raised by Health Canada, which Spartan believes are only related to the swabs used to administer testing and not the devices themselves.

Published: May 3, 2020

CBC News

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Ottawa pharmaceutical lab eyes COVID-19 vaccine with help of blood donations from COVID patients

Ottawa-based VBI vaccines is collaborating with the National Research Council to develop a COVID-19 vaccine candidate. Antibodies from people who have recovered from the disease are being used in their research. Trials are potentially months away.

Published: April 30, 2020

CTV News

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Dartmouth lab getting closer to developing COVID-19 vaccine

A biopharmaceutical company in Nova Scotia has made progress on developing a COVID-19 vaccine, hoping to start trials as soon as the summer. The company, IMV, has been aided by earlier work done on a vaccine for a serious respiratory condition that affects the elderly severely, much like COVID-19. An application to Health Canada for a trial involving 48 participants is being prepared.

Published: April 29, 2020

CTV News

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Ottawa researchers eye cancer fighting viruses in search for COVID-19 vaccine

Researchers at Ottawa Hospital are in the process of modifying cancer-fighting viruses to potentially create COVID-19 vaccines. The viruses can ’express’ tiny ‘pieces’ of COVID-19, possibly triggering an immune response when administered to a person. The team, which also involves researchers from the University of Calgary and McMaster University, recently received $250,000 in funding from Fast Grants, a venture-backed funding program for emerging COVID-19 research.

Published: April 28, 2020

CTV News

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Canadian researchers part of global effort to develop COVID-19 vaccine

A research team at the University of Saskatchewan, moving quickly towards testing a potential COVID-19 vaccine, has been boosted by the Government of Canada’s recent announcement of significant financial support for the effort to find a vaccine. The team at VIDO-InterVac (Vaccine and Infectious Disease Organization – International Vaccine Centre) hopes to test its candidate on ferrets, an animal closely related to weasels with a respiratory system similar to humans, in the next month and is also planning additional animal testing on other researchers’ vaccine candidates.

Published: April 27, 2020

CBC News

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Health Canada issues warning against use of hydroxychloroquine for COVID-19

Health Canada has issued a warning against using hydroxychloroquine and chloroquine without the supervision of a medical professional. The warning comes from concern that people may be procuring the drugs to treat COVID-19 without consulting a doctor; a similar advisory was issued in the United States by the Food & Drug Administration (FDA). The drugs can cause a number of serious side effects including liver and kidney problems, dizziness, seizures and potentially fatal irregular heartbeat.

Published: April 26, 2020

CTV News

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McGill Genome Centre to share in $20m funding for COVID-related DNA research

A new initiative, the Canadian COVID Genomics Network (CanCOGeN), will begin work sequencing the genomes of 10,000 Canadians who have been infected with COVID-19 to see if there are small differences that could explain disease severity in infected individuals.. The project will also track the genetic code of the COVID-19 virus itself, looking for small changes over time that can help to understand its severity and trajectory in Canada.

Published: April 23, 2020

McGill Reporter

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Algernon submits application to Health Canada for Ifenprodil COVID-19 phase 2b/3 multinational clinical trial

Algernon Pharmaceuticals has applied to Health Canada for a phase 2b/3 clinical trial of NP-120 (Ifenprodil), which is thought to have potential to reduce the infiltration of neutrophils and T-cells into the lungs. This could ultimately reduce the number of COVID-19 infected patients that progress to mechanical ventilation with intubation and to death. The application is designed such that a satisfactory result from a 100 participant phase 2b trial can result in immediately beginning a phase 3 trial without a new application.

Published: April 22, 2020

Globe Newswire

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Canadian company SaNOtize Research aims to limit COVID spread with nasal spray

A Vancouver-based company has announced Health Canada approval for a trial of a solution that releases nitric oxide, shown to have antiviral properties. The solution would be used as a gargle, nasal rinse and nasal spray. SaNOtize Research and Development Corp hopes to move quickly with the trial to determine if the spray can impede infection when deployed to the upper respiratory tract. If successful, the spray could have potential to protect frontline workers as well as the general population when physical distancing measures are eased.

Published: April 22, 2020

Globe and Mail

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U of T plays leading role in effort to develop COVID-19 treatment from recovered patients’ blood plasma

A major Canadian study of blood plasma from recovered COVID-19 patients is moving ahead, including with a pediatrics component conducted by a professor and researcher at the University of Toronto and Sick Kids Hospital. The study, covered in an earlier edition of the COVID-19 DEW, is being led by researchers at McMaster, the University of Toronto and University of Montreal. It plans to recruit 1,200 adults and 100 children to determine if injections of plasma from recovered patients can help treat those who are fighting COVID-19.

Published: April 21, 2020

U of T News

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Ontario researchers developing COVID-19 vaccine delivered by nasal spray

Researchers at the University of Waterloo are working on a nasal spray that will serve the dual purposes of vaccinating against COVID-19 and treating it in people who are already infected. It works by producing a virus-like particle (VLP) that stimulates an immune response to SARS-CoV-2, the virus responsible for COVID-19. It also binds to receptors commonly used by the virus, giving it fewer entry points to latch onto. While there will be much testing ahead for the spray, researchers hope the pre-clinical work will be completed by April 2021. The project is a multi-disciplinary effort involving three teams from the university.

Published: April 16, 2020

CTV News

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Alberta testing anti-malaria drug as early COVID-19 treatment

Alberta is joining Quebec and New Brunswick in trialing hydroxychloroquine (PLAQUENIL®), a drug used to treat malaria, rheumatoid arthritis and lupus, in a study by the University of Alberta and University of Calgary. There has been considerable interest in the drug as a potential treatment for COVID-19 patients and trials in a number of jurisdictions, not all of them successful. Alberta’s study seeks up to 1,660 adults at risk of developing severe COVID-19 to determine if a five-day course of hydroxychloroquine will lower hospitalization rates. Participants will be determined by Alberta Health Services.

Published: April 13, 2020

Global News

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Hamilton researchers move at ‘lightning speed’ to start trials for COVID-19 treatments

Researchers at McMaster University in Hamilton expect to soon be given Health Canada approval for a trial of COVID-19 treatments in at least 500 hospitalized and 1,000 non-hospitalized patients, with potential for the study to get quite a bit larger. Hospitalized patients will either get supportive care (the current method of treatment) or a combination of chloroquine and azithromycin (ZITHROMAX®); some hospitalized patients may also receive interferon-beta (AVONEX®), an immune modulating drug with antiviral potential. Patients not requiring hospitalization will receive supportive care or the drug combination.

Published: April 15, 2020

CBC News

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McGill challenging the world to design an innovative ventilator

McGill University is in the latter stages of the Code Life Ventilator Challenge, a contest jointly organized with the Montreal General Hospital Foundation that calls on participants to submit a design for a cost-effective and easy to build and use ventilator. A number of partners, including ScotiaBank and the Canadian Medical Association, have stepped forward with $200,000 to be distributed as prize money and to support the administration of the contest. Over 1,000 entries were received, which are in the process of being judged by a volunteer team of subject experts primarily drawn from McGill’s alumni network. An entry out of Queens University has advanced to the top 60, and final winners will be announced imminently.

Published: April 14, 2020

McGill News

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Pan-Canadian team launches covidtrials.ca to match patients with COVID-19 clinical trials

A Canadian healthcare technology company has launched a patient portal that aims to match on-going COVID-19 related trials to eligible participants. Interested people submit their relevant details through the secure portal, and if their profile matches the needs of a particular trial its organizers reach out. The team behind the portal located at https://covidtrials.ca/ feels it will fill an important need for researchers, who often struggle to fill studies with participants who meet requirements.

Published: April 15, 2020

News Wire

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Health Canada approves new rapid COVID testing kits

Ottawa-based Spartan Bioscience has received federal approval for its rapid response portable COVID-19 test. The test ships in a coffee cup-sized portable DNA analyzer and includes the swabs that are necessary for testing. It is thought to be particularly important for remote communities and to administer the kind of rapid testing believed to be necessary for a return to ‘new-normal’ life. Test results are typically available in less than an hour. The company intends to make the product widely available to governments across Canada, with the federal government, Quebec, Alberta and Ontario already having made purchases.

Published: April 13, 2020

The Globe and Mail

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Jewish General set to roll out game-changing app in COVID-19 battle

Jewish General Hospital in Montreal will be deploying a new smartphone app that monitors the user’s vital signs to help screen for COVID-19 by having them simply stare into the phone’s screen. The app will be used to identify arriving emergency room patients in need of isolation based on elevated heart rate and respiratory rate, as well as a low oxygen-saturation reading. It will also be used to monitor the vital signs of hospitalized patients and among the general population in parts of the city particularly hard-hit. While the app was designed in a Montreal-Tel Aviv partnership for broader use than just COVID-19 monitoring, the hospital has found it to be accurate and the Quebec government is considering a wider deployment.

Published: April 9, 2020

Montreal Gazette

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WHO’s SOLIDARITY trial lands in Canada, led by Sunnybrook Health Sciences Centre

Canadian hospitals will be participating in a global trial of various drugs and treatment options for COVID-19 patients that is being centrally coordinated by the World Health Organization (WHO). The trial will see lopinavir-ritonavir (KALETRA®), remdesivir, hydroxychloroquine (PLAQUENIL®) and chloroquine among the drugs that could be administered to patients. Sunnybrook Health Sciences Centre in Toronto has already begun enrolling patients, and up to 20 hospitals across Canada could ultimately participate.

Published: April 10, 2020

Trial Site News

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McGill University researchers looking for patients to test hydroxychloroquine as treatment for COVID-19

Following on the heels of New Brunswick, researchers at McGill University will begin a study on hydroxychloroquine, also known as PLAQUENIL®, as a potential treatment for COVID-19. The drug has been the subject of considerable discussion recently. Researchers are hopeful that the drug can reduce the likelihood of recently exposed people contracting the virus, and reduce the risk of complications from lung inflammation in those who have it. Adults in Quebec, Alberta or Manitoba who have tested positive for COVID-19 or had close exposure to a positive person are asked to consider enrolling.

Published: April , 20270

CTV News

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Canada begins clinical trial of experimental COVID-19 treatment using plasma from recovered individuals

A large trial using plasma, the liquid component of blood, will take place on Canadian soil, involving 1,000 patients and spanning more than 40 hospitals and some of the country’s top universities across multiple provinces. The trial will involve taking antibody-rich plasma from people who have successfully recovered from COVID-19 and injecting it into patients currently fighting the virus. Recovered patients can provide plasma at blood donation centres across the country, and if it proves to be rich enough in antibodies it will be frozen and shipped to a participating hospital.

Published: April 6, 2020

The Globe and Mail

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New Brunswick health networks collaborate on drug trial to treat people with COVID-19

New Brunswick’s two health authorities are launching a study into the efficacy of hydroxychloroquine, also known as PLAQUENIL, to treat COVID-19. The Horizon Health Network and the Vitalité Health Network are in the process of designing study details. The drug has been the subject of a recent high profile discussion as a treatment for COVID-19, leading to a rare joint statement from a number of professional associations in Ontario warning about its use pending further study. Globally, there has been a divergence among countries over how to use hydroxychloroquine/chloroquine in the face of COVID-19.

Published: April 3, 2020

CBC News

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New study from UBC researcher outlines pathway toward blocking COVID-19 virus

An international team based out of the University of British Columbia (UBC) has released findings suggesting a protein known as APN01 has potential to treat COVID-19 as an “antiviral therapy”. This largely stems from its lab-observed ability to block the virus from binding itself to a cell wall and infecting human organs. Because work to date has been done on cells and engineered human tissue, there is a long road of testing and human trials ahead.

Published: April 2, 2020

CBC News

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A look at the search for a COVID-19 vaccine in Canada

Researchers at various institutions spanning the country are working on different components of vaccine development, including building a vaccine bank, learning more about animal testing and examining the efficacy of previously known drugs to treat COVID-19.

Published: March 30, 2020

CBC News

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Dalhousie research team prepares for clinical trial of COVID-19 vaccine

Dalhousie’s COVID rapid response team believes it could be as little as three weeks away from beginning human trials on a potential COVID-19 vaccine. The team is working with a piece of the virus’s DNA, different from more conventional influenza vaccines that use a protein piece. While the team is optimistic about the accelerated timeline to begin trials, they caution that vaccines still take a long time to develop and the most realistic hope for one to be released could be in time for a potential return of COVID-19 if it follows a seasonal pattern.

Published: March 25, 2020

CBC News

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Montreal Heart Institute launches clinical study into potential COVID-19 treatment

Researchers in Montreal are rushing to launch a study into whether colchicine, an inexpensive anti-inflammatory drug most commonly used to treat gout, can reduce the risk of lung complications that characterizes the most serious COVID-19 cases. The trial seeks to recruit 6,000 adults 40 years of age or older, with half given a placebo (e.g. sugar pill) and half colchicine, and researchers are hopeful that some conclusions can be drawn in as little as 30 days.

Published: March 23, 2020

CBC News

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Joint Statement on the Use of Hydroxychloroquine and Azithromycin for COVID-19 Prophylaxis

Professional associations representing doctors, pharmacists and nurses issued a rare joint statement urging caution to their members around unproven applications of hydroxychloroquine (PLAQUENIL®) and azithromycin (ZITHROMAX®) for COVID-19 treatments. The statement highlights a number of concerns about the two drugs being used in tandem, and notes an uptick in the drugs being prescribed jointly, something uncommon before COVID-19.

Published: March 24, 2020

My RNAO

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Quebec Company Partners with Government to Find a Cure

Medicago, a Quebec City-based company that successfully produced an H1N1 vaccine candidate in just 19 days, has partnered with the federal government as part of its effort to create a COVID-19 vaccine. The federal government has committed $192 million to the cause, of which Medicago will receive $7 million. The company has succeeded at creating a “virus like particle” and hopes to trial a vaccine in humans by summer 2020.

Published: March 23, 2020

CTV News

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Coronavirus vaccine by Oxford-AstraZeneca produces immune response among adults

A promising vaccine candidate developed at the University of Oxford and manufactured by AstraZeneca has shown promise in terms of the strength of the immune response it elicits from older and younger adults. AstraZeneca released the information based on results from clinical trials. In addition to a strong immune response, older people also had a low incidence of adverse reactions, which is an important factor given that age group’s risk of severe disease. A person’s immune response is what offers protection from the virus, so a vaccine candidate’s ability to trigger one is critical.

Published: October 26, 2020

Global News

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2 coronavirus vaccine trials resume final-stage testing after pauses

Two drug manufacturers have announced the resumption of late stage COVID-19 vaccine trials in the United States after temporary pauses over safety incidents. AstraZeneca resumed its trial on October 23rd, and Johnson & Johnson is doing so early in the week of October 26th. Safety pauses are not uncommon in large trials, as regulators and other safety experts seek to determine if adverse events were caused by the drug or vaccine being tested or are coincidental.

Published: October 23, 2020

CBC

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Chinese state firm prepares production line for 1 billion COVID-19 vaccine doses

SinoPharm Group, a state-owned Chinese drug manufacturer, is making preparations to be able to supply one billion doses of two potential COVID-19 vaccines that are in late stage trials in 10 countries. The production capacity should be established in 2021. More than 60,000 people have participated in late stage COVID-19 vaccine trials.

Published: October 20, 2020

CP24

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Healthy volunteers will be deliberately infected with coronavirus as part of U.K. study

The UK government has agreed to help fund a ‘challenge’ trial in which participants are intentionally exposed to COVID-19, in hopes to gain quicker and more relevant information on the efficacy of vaccines. The first step is known as a characterization study, where researchers determine the lowest level of exposure necessary in order to cause symptom onset in participants between the ages of 18 and 30. This is an important step in helping researchers understand how the human body reacts to a dose of the virus. From there another pool of participants will be given a vaccine candidate and exposed to COVID-19. The characterization study will begin in early 2021.

Published: October 20, 2020

CTV News

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Global COVID-10 treatment trial shows current antivirals are of little benefit to hospitalized patients

The World Health Organization’s (WHO) Solidarity Trial, with sites in 30 countries and over 11,000 patients in 405 hospitals, has concluded that several antivirals thought to hold promise in treating COVID-19 were not effective at reducing 28-day mortality or changing the course of hospitalized patients’ illness. The drugs studied were remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens.

Published: October 16, 2020

UBC Faculty of Medicine

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2nd COVID-19 vaccine trial paused over unexplained illness

Johnson & Johnson’s COVID-19 vaccine candidate’s late stage clinical trial was paused following an ‘unexplained illness’ in a participant. The company is investigating whether the individual received the vaccine candidate, or a placebo, and whether their illness is related to their participation in the trial. Another promising COVID-19 vaccine candidate, developed at Oxford University and manufactured by AstraZeneca, saw a late stage trial paused following a safety event weeks ago, however it has since been resumed in jurisdictions outside of the United States.

Published: October 13, 2020

CBC

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Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

A clinical trial of US-based drug manufacturer Eli Lilly & Co’s COVID-19 antibody treatment has been suspended following a reported safety concern. The drug, LY-CoV555, is undergoing a 10,000 participant government-sponsored study called ACTIV-3; an independent safety panel advised the pause. The antibody treatment is being tested in hospitalized COVID-19 patients, and in nursing homes to determine if it can prevent infection in those settings.

Published: October 13, 2020

Yahoo! Finance

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EU launches rolling review of the Pfizer-BioNTech coronavirus vaccine

The European Medicines Agency (EMA) has announced a “rolling review” of data from two late stage COVID-19 vaccine candidates under development by AstraZeneca and Pfizer/BioNTech respectively. By reviewing data as it becomes available rather than reviewing a large quantity of data with the formal final application, the agency hopes to speed up evaluations of vaccines during the pandemic.

Published: October 6, 2020

CNBC

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Moderna’s coronavirus vaccine won’t be ready before late November, CEO says

Moderna CEO Stéphane Bancel has signalled that late November is the earliest that the company could seek Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate, currently in late stage trials. This is based on an arrangement with US regulators that would see an EUA based on two months of safety data from half of the trial participants. The 15,000th participant (out of 30,000) was administered their second dose on September 25, pointing to the late November timeline based on two months of safety data.

Published: October 2, 2020

Fierce Pharma

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Common low-cost antioxidant enzyme is potential treatment for COVID-19

Research teams in California and China see potential for a naturally occurring enzyme, catalase, to help treat COVID-19 symptoms and suppress the reproduction of the virus. Catalase was found to regulate the production of cytokines, which may be helpful in combatting the cytokine storms – an extreme inflammatory response – that are often seen in severe COVID-19 patients.

Published: September 29, 2020

SciTech Daily

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Johnson & Johnson begins final phase of single-shot COVID-19 vaccine study

Drug manufacturer Johnson & Johnson has launched a final phase 3 study of its COVID-19 vaccine candidate, seeking out 60,000 participants across the United States, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. It is administered as a single dose, unlike some of the other leading candidates which are delivered in two doses. Pfizer, Moderna and AstraZeneca are among the manufacturers that also have candidates in late stage trials.

Published: September 23, 2020

CBC

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Moderna reveals detailed plans for COVID-19 clinical trial

Moderna has published details on the protocol for its United States-based Phase 3 COVID-19 vaccine clinical trial. The company is nearing its goal of 30,000 participants, currently at just over 25,000 – including 30% from minority communities, an important factor that could delay approval if underrepresented, as was discussed in an earlier COVID-19 DEW Report. Just over 10,000 participants have received their second dose of the vaccine candidate, which is administered 28 days after the first dose. Other on-going Phase 3 trials are being led by Pfizer and AstraZeneca.

Published: September 17, 2020

CTV News

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AstraZeneca resumes COVID-19 vaccine trial after UK green light

A temporary pause in clinical trials of the much-touted COVID-19 vaccine candidate developed at Oxford University and manufactured by AstraZeneca has been lifted. Regulators in the UK and Brazil have allowed trial sites to resume following a pause of several days after a participant experienced a neurological adverse event. AstraZeneca has committed to deliver billions of doses worldwide should the candidate be successful. Up to 18,000 people are thought to have received a dose via current phase 3 trials, which include a large body of participants in order to test for safety and efficacy.

Published: September 12, 2020

CTV News

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Steroids cut death rates among critically ill COVID-19 patients, studies suggest

Combined results from seven separate trials around the world show that treatment with steroids can decrease the risk of death among hospitalized intensive care COVID-19 patients by 20%. Studies from Britain, Brazil, Canada, China, France Spain and the United States were analyzed by a World Health Organization (WHO) team to conclude that low doses of hydrocortisone, dexamethasone and methylprednisolone improve survival rates in severe patients regardless of other factors such as age, sex and whether ventilation was being used at the start of treatment. The WHO has updated its guidelines on treating COVID-19 to reflect the new analysis. Analysts believe that steroids’ role in reducing inflammation, a common feature of severe COVID-19 patients, is a factor in the results.

Published: September 2, 2020

CBC News

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BioNTech, Pfizer begin German part of COVID-19 vaccine study

BioNTech and Pfizer have obtained approval from Germany’s vaccines regulatory body to expand a global Phase 2/3 trial of its COVID-19 vaccine candidate into that country. More than 25,000 participants have been enrolled in the trial since July, with plans to eventually cover 120 sites and 30,000 total participants. BioNTech officials are confident the trial is on track and that its candidate could be before regulators looking for approval as soon as October.

Published: September 7, 2020

The Guardian

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Sinovac says its coronavirus vaccine candidate appears safe for elderly in early trials

Early stage human trial results out of China suggest that Sinovac Biotech’s COVID-19 vaccine candidate appears to be safe to use in older individuals. A combined Phase 1 and 2 trial with 421 participants 60 years of age and older did not show severe side effects, while the group did see an increase in antibodies – albeit not as dramatic of an antibody increase as younger participants showed, which is consistent with what trial organizers expected. The candidate, named CoronaVac, is in advanced large-scale trials across Brazil and Indonesia.

Published: September 7, 2020

CBC News

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Trump announces plasma treatment authorized for COVID-19

United States President Donald Trump has issued an emergency authorization for the use of convalescent plasma in COVID-19 patients. The treatment, which is being studied in Canada and has been documented in past COVID-19 DEW Reports, involves taking antibody rich blood plasma from recovered COVID-19 patients and giving it to those fighting an active infection. While Mayo Clinic researchers have provided some evidence that convalescent plasma can improve patient outcomes, their data was collected from various sources without the controls of a formal study, so it is not considered firm proof of plasma’s effectiveness.

Published: August 23, 2020

CBC News

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COVID-19 vaccine trials have been slow to recruit Black and Latino people – and that could delay a vaccine

Some experts have raised concerns that a lack of minorities participating in advanced clinical trials of several COVID-19 vaccine candidates could delay efforts to bring a vaccine to market, as study groups do not reflect the general population. Out of 350,000 participants registered only 10% are Black or Latino, despite nearing half of all confirmed COVID-19 cases coming from those groups. A coordinating doctor on the United States’ Operation Warp Speed indicated that if not enough minorities enrol, the trials could face delays until enough participants are included.

Published: August 16, 2020

CNN Health

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Scientists uneasy as Russia approves first coronavirus vaccine

Russia has become the first country to approve a COVID-19 vaccine for widespread use, but the scientific community is expressing reservations and encouraging caution as the shot has yet to be exposed to large scale phase III trials. The candidate was developed by the Gamaleya Institute in Moscow and uses similar design features to those being worked on by CanSino and Oxford University/AstraZeneca, however the Russian government has not provided public evidence of early trial results. The government has indicated doctor vaccinations could begin imminently, with larger scale production for the fall.

Published: August 11, 2020

CTV News

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Pfizer inks manufacturing deal with Gilead for COVID-19 med remdesivir

Pfizer and Gilead have entered into a multi-year deal to increase production of remdesivir, a drug that has been issued approvals in some countries, including Canada, to treat COVID-19. Pfizer will produce the antiviral at a manufacturing site in Kansas, US. Studies have shown that remdesivir can reduce recovery times in COVID-19 patients.

Published: August 10, 2020

PharmaTimes

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Lilly initiates trial of neutralizing antibody against COVID-19

Eli Lilly has partnered with the US National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase III trial, named BLAZE-2, of its drug LY-CoV555 to determine its ability to prevent COVID-19 in residents and staff at long-term care facilities that have had a recently diagnosed case of COVID-19. LY-CoV55 is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. Up to 2,400 participants will be recruited in the United States, and the primary goal of the study will be to assess whether the drug decreases the rate of SARS-CoV-2 infection rates over 4 weeks, and symptoms or complications of COVID-19 over 8 weeks.

Published: August 4, 2020

Clinical Trial Arena

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Operation Warp Speed secures another potential vaccine

The United States’ Operation Warp Speed, designed to bring a COVID-19 vaccine to candidate as quickly as possible, continues to secure pre-orders from manufacturers in the event they produce a successful shot. The most recent addition is a $2.1 billion, 100 million shot commitment from Sanofi and GlaxoSmithKline, with government funds supporting the development of the candidate, administration of clinical trials, manufacturing and delivery of the vaccine. In total the United States has committed $6 billion towards securing hundreds of millions of shots from several promising candidates, including Johnson & Johnson, Moderna, Novavax, Pfizer and Merck, as well as a shot from the University of Oxford manufactured by AstraZeneca.

Published: August 3, 2020

Kaiser Health News

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AbbVie, Amgen and Takeda test anti-inflammatory drugs in joint COVID-19 study

Three large drug manufacturers have teamed up to administer a joint trial aimed at determining if one of their existing products can be repurposed to treat severe COVID-19. Dubbed I-SPY, the trial will look at Amgen’s psoriasis drug OTEZLA (apremilast), Takeda’s hereditary angioedema medication FIRAZYR (icatibant) and AbbVie’s experimental nonalcoholic steatohepatitis drug cenicriviroc. The study will aim to improve the scoring of patients on high-flow oxygen by a minimum of 1 point on the World Health Organization’s COVID-19 status scale for 48 hours. The companies felt there was benefit to administering the trials jointly rather than individually, including reducing the number of patients and time to evaluate drugs.

Published: August 3, 2020

Fierce Pharma

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Moderna and Pfizer begin late-stages coronavirus vaccine trials

Two late-stage clinical trials of COVID-19 vaccine candidates began on Monday, July 27th, as Moderna’s 30,000 person trial administered its first shot to a participant in Savannah, Georgia and another trial of the same size featuring a candidate developed jointly by Pfizer and BioNTech was kicked off in Rochester, New York. Both candidates use messenger RNA (mRNA), a form of genetic material that replicates the coronavirus, to trigger an immune response in participants. The United States National Institutes of Health (NIH) expects three more phase 3 trials to begin soon, each requiring 30,000 participants.

Published: July 27, 2020

New York Times

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Oxford University COVID-19 vaccine shows promising results

The University of Oxford’s much-touted vaccine candidate returned some positive news from clinical trials, showing increased levels of protective neutralizing antibodies and immune T-cells that target COVID-19 in 1,077 adult participants. The vaccine also demonstrated good safety outcomes in that group, with minor side effects reported, most commonly fatigue and headache. The news followed similar reports for a candidate being put forth by Pfizer and BioNTech. Manufacturer AstraZeneca has made significant global commitments to deliver the Oxford vaccine should clinical trials be successful. A larger trial of 40,000 participants is underway and if it produces positive results a limited approval could be issued by December.

Published: July 20, 2020

Globe and Mail

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‘Good news’: First trial of COVID-19 vaccine by drug developer Moderna shows it induces virus-killing antibodies

A report in the New England Journal of Medicine showed positive results for a vaccine candidate being put forth by Moderna Therapeutics out of Cambridge, Massachusetts. All 45 participants who had received two doses of the vaccine showed high levels of antibodies, exceeding what has been seen even in patients who have successfully recovered from COVID-19. Some participants experienced mild side effects such as soreness and fatigue, most commonly seen in those who received a high dose of the second shot.

Published: July 15, 2020

Ottawa Citizen

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Chinese pharma company CanSino in talks for Phase III trial of COVID-19 vaccine

CanSino is in discussions with several countries, including Russia, Chile, Brazil and Saudi Arabia about organizing phase 3 trials of its COVID-19 candidate, which it hopes to test in 40,000 participants. The vaccine has been approved for use in China’s military, and has also been approved for earlier stage human trials in Canada, although those trials have not begun due to the Chinese government not yet approving shipment of the vaccine to Canada. CanSino has had difficulty finding enough participants for a phase 3 trial in China due to relatively low infection numbers.

Published: July 12, 2020

British Herald

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UK researchers back use of steroid inhalers during pandemic

Researchers in the UK have published findings asserting that the benefits of steroid inhalers/nebulizers used in people with asthma or chronic obstructive pulmonary disease (COPD) outweigh the risks, conflicting with earlier World Health Organization (WHO) guidance that steroid inhalation could make people more susceptible to severe cases of COVID-19. The team at Huddersfield University recommends patients continue taking all medications, including steroids. Remdesivir, a drug approved to treat COVID-19 in several countries, is in the process of having an inhaled version developed.

Published: July 9, 2020

Pharma Times

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Gilead begins PhI trial of inhaled remdesivir

Gilead Science will begin an early phase (1a) trial of an inhaled version of remdesivir. The intravenous (IV) IV formulation of remdesivir, which has been shown to reduce patients’ recovery time by about 4 days, has been approved to treat COVID-19 in a number of countries but can currently only be administered in hospital settings. The trial will enrol 60 healthy participants in the US, aged 18-45.

Published: July 9, 2020

Pharma Times

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Coronavirus: Gilead's COVID-19 antiviral gets conditional EU approval

Gilead Science’s antiviral drug remdesivir has been granted conditional approval by the European Commission to treat severe COVID-19 patients. It has been shown to reduce recovery time by about 4 days in infected individuals, although there is not yet evidence it can decrease mortality. The drug has received approvals in a number of countries, including the UK and US, and Gilead recently unveiled pricing, documented in earlier COVID-19 DEW Reports.

Published: July 4, 2020

Yahoo Sports

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Potential coronavirus vaccine has “right sort of response” in trial

A leading researcher working on the University of Oxford’s much heralded COVID-19 vaccine candidate has indicated she is encouraged by the immune response being shown in clinical trials. The candidate is currently undergoing phase 3 trials involving 8000 participants, and drug manufacturer AstraZeneca has committed to delivering billions of doses worldwide if it proves successful.

Published: July 1, 2020

Global News

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Gilead’s US $2,340 price for coronavirus drug draws criticism

Gilead Science has set its price for remdesivir in the US and other developed countries. A five-day course will cost US$2,340 for patients in the United States covered by government health programs, as well as in other developed countries. The price will be higher for Americans with private insurance, with treatment costing $3,120. Remdesivir is an antiviral drug that has been featured in previous editions of the COVID-19 DEW Report and has been observed in some clinical trials to shorten recovery time in COVID-19 patients. It is currently administered intravenously in a hospital setting, though Gilead will be trialling an inhaled solution of the drug.

Published: June 29, 2020

CTV News

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China approves COVID-19 vaccine for military use, skips final phase of testing

China’s Central Military Commission has approved a COVID-19 vaccine candidate developed by CanSino, which has also been authorized for clinical trials in Canada, for use in military members. The vaccine has shown potential to prevent COVID-19 in phase 1 and 2 trials, however it is still pending a more comprehensive phase 3 trial to evaluate the efficacy and safety on thousands of people.

Published: June 29, 2020

CBC News

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Brazil signs $127m agreement to produce COVID-19 vaccine

AstraZeneca continues to extend the global footprint of its COVID-19 vaccine candidate, being developed by the University of Oxford. Brazil has committed $127 million to produce 30 million doses, half by December 2020 and the other half January 2021. This follows significant commitments to produce more than a billion doses across Europe and the United States. AstraZeneca’s candidate is widely seen as the most promising among vaccine candidates currently under development.

Published: June 27, 2020

UPI

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Gilead to test a version of remdesivir that can be inhaled

Gilead Science’s antiviral drug remdesivir, which has shown some positive results in treating COVID-19 patients, will soon have a nebulized (inhaled) version ready for clinical trial. The drug previously has only been available for intravenous use, which requires that it be administered in hospital settings. It is thought that an inhaled version could be more accessible to patients, especially at earlier stages of the disease, although researchers will be exploring potential complications, such as whether the drug acts quickly enough when nebulized or how patients with lung damage respond to it.

Published: June 22, 2020

The New York Times

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GSK/Clover's COVID-19 vaccine moves into human trials

A collaboration between the UK’s GlaxoSmithKline and China’s Clover Pharmaceuticals to find a COVID-19 vaccine is advancing to a clinical trial. The candidate, which is an adjuvanted vaccine (has an added component to strengthen the immune response) showed promising preclinical results including high antibody levels in animals and now will enter a phase 1 trial.

Published: June 22, 2020

Pharma Times

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MMR vaccine may protect against COVID-19, researchers suggest

Research in the United States suggests some potential that the measles, mumps and rubella (MMR) vaccine could offer protection against COVID-19, particularly against the lung inflammation that can characterize severe cases. Some of the evidence presented includes the fact that children, who are often exposed to vaccines more frequently than adults, seem to be less affected by COVID-19 than other age groups. It is important to note that further lab work is required to determine with certainty if the MMR vaccine would offer a benefit, and that it is only being presented to help prevent an individual from developing severe disease.

Published: June 19, 2020

CTV News

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Johnson & Johnson in talks to supply COVID-19 vaccine in Europe: reports

After weeks of commitments from AstraZeneca to provide COVID-19 vaccine shots across Europe if its candidate succeeds, Johnson & Johnson is also in talks with the European Commission to secure a commitment for its shot, which is undergoing clinical trials. There is considerable jockeying for guaranteed access to an eventual COVID-19 vaccine, as Sanofi is also negotiating in Europe. All three companies also have varying levels of commitment to provide shots to the United States.

Published: June 19, 2020

Fierce Pharma

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First human trial of potential antibody treatment for Covid-19 begins

Eli Lilly and Company is collaborating with a Canadian partner to deliver the first human trial of antibody treatment in COVID-19 patients in the United States. Vancouver-based AbCellera has isolated antibodies from recovered COVID-19 patients in the US, which Eli Lilly has engineered into a monoclonal antibody therapy. New York University's Grossman School of Medicine, Cedars-Sinai in Los Angeles and Emory University in Atlanta will be sites that begin administering the treatment to hospitalized COVID-19 patients, and if successful it could be made available by fall.

Published: June 2, 2020

CNN

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Novartis to manufacture partner’s COVID-19 vaccine ‘at no cost’

Novartis has entered the race for a COVID-19 vaccine, partnering with the Massachusetts Eye and Ear and Massachusetts General Hospital to test a vaccine candidate that will be developed by its subsidiary AveXis. AveXis will provide its expertise and production capabilities at no cost for the purposes of supplying the trials, and Novartis will retain the option to manufacture the candidate commercially if the trials are successful.

Published: June 1, 2020

BioPharma

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Pfizer CEO has announced that the Covid vaccine will be ready by the end of October -

Pfizer’s CEO has expressed confidence the company’s COVID-19 vaccine candidate will be approved for use by the end of this year. As was covered in an earlier edition of the COVID-19 DEW, the company is partnering with BioNTech on a candidate that is currently undergoing clinical trials in the United States and Europe.

Published: May 31, 2020

First Word Pharma

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Oxford, AstraZeneca Begin Advanced Trials of Covid Vaccine

A promising vaccine candidate out of Oxford University in the UK is moving towards a large clinical trial in conjunction with AstraZeneca. More than 10,000 participants are being sought, including a younger age group aged 5-12, as well as a group of participants above 55. Most participants will be aged 18 and up.

Published: May 22, 2020

Bloomberg

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Monkeys infected with COVID-19 develop immunity in studies, a positive sign for vaccines

New research suggests that monkeys develop immunity to COVID-19 following infection from it, an important fact to establish as vaccine development moves forward. In one study, nine monkeys infected with the virus were unable to be re-infected following recovery, while in another study monkeys that received a vaccine candidate showed significant, and in some cases, total, protection from the virus compared to a control group.

Published: May 20, 2020

National Post

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Early results from Moderna vaccine trial show participants developed antibodies against coronavirus

Cambridge, U.S.-based Moderna is reporting positive results from the first trial of its COVID-19 vaccine candidate. The phase 1 trial administered the shot to dozens of participants, and of the 8 who later had antibody readings taken, all showed the development of antibodies that help prevent infection. Moderna has already been approved for a phase 2 trial and hopes to be conducting a phase 3 trial with thousands of participants by July.

Published: May 18, 2020

CTV News

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Exvastat wins 3.6m euro grant for COVID-19 trial

Ireland-based Exvastat has won a 3.6 million euro grant from the Innovative Medicines Initiative to reformulate imatinib (GLEEVEC®), a cancer drug that slows the growth of certain cells. It is thought that the drug can be used to reduce the build up of lung fluid to treat Acute Respiratory Distress Syndrome (ARDS) in severe COVID-19 patients. A number of companies, including Vrije Universitat, Amsterdam Medical Center, KABS (Canada) and Simbec-Orion will participate.

Published: May 15, 2020

Pharma Times

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U.S. FDA probes accuracy issue with Abbott's rapid virus test

The United States Food & Drug Administration (FDA) is investigating concerns that Abbott’s recently approved rapid COVID-19 test is missing positive cases, potentially clearing individuals with the virus. Reports from various researchers suggest a range of missed positives from one-third to half of all tests. Abbott disputes the concerns, claiming the data in question was collected by administering the test improperly with too long of a delay between when the sample was taken and processed.

Published: May 15, 2020

CBC News

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NIH to test hydroxychloroquine, azithromycin combination as potential COVID-19 treatment

The United States National Institute of Health (NIH) is launching a randomized, controlled phase 2b trial of hydroxychloroquine and azithromycin (ZITHROMAX®) to determine the combination’s suitability to reduce hospitalizations and deaths in COVID-19 patients with mild to moderate symptoms. A group of 2,000 participants will be randomized to receive the drug combination or placebo. Participants will take the therapy at home and record symptoms, with full results possibly available by the end of the year.

Published: May 14, 2020

First Word Pharma

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Pfizer to outsource some drug production, focus on coronavirus vaccine

Drug manufacturer Pfizer has taken further steps to prepare for large scale production of its COVID-19 vaccine candidate should it be successful in clinical trials currently underway. The company has shifted production of some of its other drugs to outside contractors in order to prepare its own vaccine manufacturing facilities to produce hundreds of millions of doses by 2021.

Published: May 10, 2020

First Word Pharma

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Triple combination therapy shows promise for COVID-19 patients with less severe illnesses

A triple antiviral therapy made up of interferon beta 1b, lopinavir-ritonavir and ribavirin showed improvements in patient recovery time compared to a control group taking only lopinavir-ritonavir. According to results published in The Lancet, among 127 participants with mild to moderate COVID-19 symptoms, those taking the three-drug combination typically tested negative for the virus five days sooner than those just on lopinavir-ritonavir.

Published: May 10, 2020

First Word Pharma

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U.S. FDA approves emergency authorization for coronavirus antigen test with fast results

The United States Food & Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for a new COVID-19 antigen test. Developed by Quidel Corp of San Diego, the test rapidly detects proteins that signal the virus’s presence in the nasal cavity, giving results in 15 minutes.

Published: May 9, 2020

Globe and Mail

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Algernon to begin COVID-19 human trials in South Korea

Vancouver-based Algernon Pharmaceuticals will begin a 40-participant clinical trial of its repurposed drug NP-120 (ifenprodil) in South Korea, and has pending applications for a multinational trial of the drug in Canada, the United States and Australia. The drug, originally developed to treat circulatory disorders and currently being trialed for use treating patients with idiopathic pulmonary fibrosis (IPF), is thought to have potential to protect the lungs from inflammation, which is typically the most severe symptom in critically-ill COVID-19 patients.

Published: May 7, 2020

Financial Post

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FDA gives okay for Moderna to advance coronavirus vaccine candidate mRNA-1273 to Phase II testing

Moderna has received United States Food & Drug Administration (FDA) approval to begin a phase 2 clinical trial of its mRNA-1273 COVID-19 vaccine candidate. The trial will enrol 600 participants. A phase I trial began in March under the National Institute of Health (NIH), and an application is being prepared for a phase 3 trial to commence in early summer.

Published: May 7, 2020

First Word Pharma

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Pfizer starts U.S. trials of experimental coronavirus vaccine

Pfizer’s COVID-19 vaccine candidate has begun clinical trials in the United States, with patients enrolled from the NYU Grossman School of Medicine and the University of Maryland’s School of Medicine. The candidate will be tried on 360 participants aged 18-55, and if safety and immunity can be seen in that group the trial will expand to a group aged 65-85. The company, which is partnering with BioNTech in this effort, will examine four different candidates in hopes of having one finalist ready for the fall.

Published: May 5, 2020

BNN Bloomberg

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French drugmaker to enrol thousands for coronavirus vaccine trials

Sanofi SA is partnering with industry rival GlaxoSmithKline Plc (GSK) to develop a COVID-19 vaccine candidate it believes could face clinical trials by September. Sanofi will contribute a protein antigen, a molecule that can help trigger an immune response, based off its influenza vaccine, while GSK will provide an approved adjuvant – a response-boosting agent – to increase antibodies and produce longer-lasting immunity. The plan is for an early stage phase I/II trial that enrols hundreds of participants in order to obtain more data than earlier trials typically provide, with hopes of late-stage trials with thousands of participants no later than early 2021.

A rundown of all COVID-19 vaccine developments can be viewed here.

Published: May 5, 2020

Globe and Mail

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FDA issues emergency use green light for Gilead’s remdesivir

The United States Food & Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for Gilead’s antiviral drug remdesivir for use in adults and children hospitalised with severe disease, following trial results that showed improvements in recovery time for hospitalized patients. The National Institute of Health (NIH) study, documented in an earlier edition of the COVID-19 DEW, showed a 31% increase in recovery time for patients taking remdesivir over placebo. The emergency authorization is temporary, allowing for healthcare professionals to administer the drug in the United States until the circumstances warranting the authorization change.

Published: May 4, 2020

Pharma Times

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FDA grants emergency authorization to Roche antibody tests

The United States Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Roche’s COVID-19 antibody test. Roche states the test is 100% accurate in determining the presence of antibodies, and 99.8% accurate in ruling them out. The company believes it can produce 100 million units by the end of the year.

Published: May 3, 2020

Forbes

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Moderna aims for a billion COVID-19 shots a year with Lonza manufacturing tie-up

Moderna Therapeutics has found a manufacturer for its COVID-19 vaccine candidate, partnering with Lonza in a deal that could, over the long-term, bring production capacity to 1 billion shots per year. The company has a vaccine candidate, known as mRNA-1273, in a phase 1 trial in the United States, and has an application in to begin a phase 2 trial.

Published: May 1, 2020

Fierce Pharma

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Antiviral drug remdesivir shortens time to recover from pandemic virus, top US health official says

A large study enrolling 1,063 participants run by the United States’ National Institute of Health (NIH) on Gilead Sciences’ remdesivir shows COVID-19 patients taking the drug had recovery times improved by 31% (at 11 days, compared to 15 days for those receiving standard of care) leaving some, including Dr. Anthony Fauci, to believe it will soon become the country’s standard of care for treating the disease. There was more interest in the results from this trial because it involved comparing the results against a control group receiving placebo, unlike some earlier remdesivir trials. The global view for remdesivir results was a bit more mixed, as a study out of China published by The Lancet showed no improvement in patient outcomes. However, Gilead and analysts suggested that the study was inconclusive to draw meaningful conclusions as it was terminated early due to insufficient participants.

Published: April 29, 2020

CBC News

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Diagnostics firm says new Covid-19 test could be used 1 million times a week

Hologic, a Massachusetts-based diagnostic test manufacturer, believes it could create 1 million units per week of its new COVID-19 test, a development that if it materialized would dramatically increase the United States’ testing capacity. The new tests run on a different version of existing COVID-19 testing technology and uses a proprietary technology. The company has applied for Emergency Use Authorization (EUA) for the product; until authorization is granted, it will be supplying it to labs governed by regulations that would allow its use prior to an EUA.

Published: April 29, 2020

Stat News

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Arthritis drug shows early promise in severe COVID-19 cases study

A rheumatoid arthritis drug has shown potential to fight off the extreme inflammation that characterizes many severe COVID-19 cases in a clinical study out of France. Tocilizumab (ACTEMRA®) was used in a trial of 129 moderate to severe pneumonia patients, a known complication of COVID-19. While full results are not yet out, researchers involved in the study say that compared to a control group, those receiving the drug had a reduced number of deaths or life support interventions.

Published: April 28, 2020

CTV News

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In race for a coronavirus vaccine, an Oxford group leaps ahead

A team from the Jenner Institute at Oxford University will be testing a COVID-19 vaccine candidate in more than 6000 people by the end of May, thanks to earlier vaccine development work on similar viruses including a coronavirus from last year. While many trials of potential COVID-19 vaccines start off with a few hundred participants, the Oxford team is moving forward at an accelerated pace after six rhesus monkeys who received their vaccine in the United States are healthy approximately a month after heavy exposure to COVID-19. The team believes that under the accelerated timeline, there is the possibility of a few million doses being available by September, far ahead of any other vaccine candidate currently being studied.

Published: April 27, 2020

The New York Times

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China’s Sinovac amps up COVID-19 vaccine work with new facility backed by Chinese government

Chinese biotech firm Sinovac has obtained government assistance to finalize its push to produce up to 100 million units of COVID-19 vaccine per year if its candidate is successful. An $8.5 million low-interest loan will be used to construct a production facility, which will be repurposed for other vaccines if its COVID-19 candidate is unsuccessful.

Published: April 24, 2020

Fierce Pharma

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Did Gilead’s remdesivir flop a Chinese trial? Analysts beg to differ

There is disagreement over media characterizations of leaked results of an aborted remdesivir trial in China. After the World Health Organization (WHO) inadvertently released data from a study that was suspended due to lack of participants, the Financial Times picked up the story and described the trial as a “flop.” In the posted results, remdesivir was not associated with clinical or virological benefits. However, some analysts and remdesivir manufacturer Gilead Sciences point out that due to the small number of patients, the trial did not capture enough data to draw meaningful conclusions. As well, the manufacturer notes that better results were observed in patients treated early in their disease, although they did not provide data to support this statement.

Published: April 23, 2020

Fierce Biotech

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Lilly to start testing experimental drug in coronavirus patients soon

Eli Lilly hopes to begin human trials of an antibody treatment derived from the blood of recovered COVID-19 patients in the next month under a partnership with AbCellera Biologics. Eli Lilly will apply to the United States Food & Drug Administration (FDA) sometime in May and is prepared to move into a trial soon after approval. The company sees a potential antibody treatment as a bridging option until a vaccine is available.

Published: April 23, 2020

First Word Pharma

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Pfizer and new partner BioNTech nab approval to start closely watched COVID-19 vax test

Pfizer and BioNTech have been granted approval in Germany to begin a phase 1/2 trial of 4 mRNA COVID-19 vaccine candidates. Each candidate is a different format and targets different antigens. The trial will look for optimal dosing and study the effects of repeated immunization in 200 18- to 55- year old healthy subjects, and will test additional high-risk candidates in the second stage.

Published: April 22, 2020

Fierce Biotech

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Hydroxychloroquine takes another hit in failed small scale COVID-19 study

A small-scale analysis of 368 severe COVID-19 patients treated in US Department of Veterans Affairs hospitals found no evidence of reduced risk of death or need for mechanical ventilation over supportive care among those treated with hydroxychloroquine, on its own or in combination with azithromycin (ZITHROMAX®). In fact, those patients given hydroxychloroquine on its own showed an increased risk for all-cause mortality. The study is one of many on-going around the world to determine the suitability of hydroxychloroquine and its analog chloroquine, two old anti-malaria drugs that have recently garnered attention in the search for a COVID-19 treatment.

Published: April 22, 2020

Fierce Pharma

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Alexion, following clues from early tests, preps phase 3 study of Ultomoris in severe COVID-19

Alexion is beginning a global phase 3 trial of ULTOMIRIS® (ravulizumab-cwvz) that will involve about 270 patients with severe COVID-19 symptoms, including pneumonia and respiratory distress. By inhibiting the complement portion of a patient’s immune system, it is thought that the drug can reduce lung inflammation, as well as lower cytokine and chemokine levels. Alexion has also considered further trials of SOLIRIS® (eculizumab) but opted for ULTOMIRIS®, a follow-up drug to SOLIRIS®, due to the less frequent dosing required and easier scaling of production.

Published: April 20, 2020

Fierce Pharma

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Gilead’s remdesivir looks promising in early leaked results, but don’t jump to conclusions: analysts

COVID-19 patients at the University of Chicago Medical Centre have responded well to remdesivir, with most patients being discharged following decreasing fever and improved respiratory symptoms. The hospital is in the midst of two phase 3 trials involving 125 patients, including 113 severe cases. It’s important to note that these results were shared by an infectious disease specialist at the hospital on a call with other staff, and were not publicly released; they do not represent full trial results. The Chicago study is one of several underway around the world to determine remdesivir’s suitability as a COVID-19 treatment.

Published: April 16, 2020

Fierce Biotech

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World’s biggest trial of drugs to treat COVID-19 begins in UK

The world’s largest trial of COVID-19 treatments is underway in the United Kingdom, with more than 5,000 patients enrolled representing 10% of all confirmed cases. The trial is starting with a number of repurposed drugs, including azithromycin (ZITHROMAX®), hydroxychloroquine, lopinavir-ritonavir (KALETRA®) and low-dose dexamethasone. The next drug to be added is an interleukin-6 antagonist, tocilizumab (Actemra), an immunomodulator used to treat inflammatory conditions. There is also discussion of including convalescent plasma. Because of the trial’s size, each drug already has between 500 and 900 patients, plus a control group of 2,000.

Published: April 17, 2020

The Guardian

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Roche to launch COVID-19 antibody test by early May

Following Roche’s launch of a test for active COVID-19 infections, the company has announced plans to release an antibody test for the virus next month. The Elecsys Anti-SARS-CoV-2 serology test will help identify people who have been infected with the disease, including those who may not have had any symptoms, and will be useful for return-to-work planning and modelling how widely it has infected a population. The technology has potential to provide results in 18 minutes and process up to 300 tests per hour.

Published: April 17, 2020

Fierce Biotech

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J&J eyes ‘imminent’ coronavirus vaccine production, aims for a billion doses worldwide

Johnson & Johnson (J&J) has begun “at risk” manufacturing of its COVID-19 vaccine candidate, forecasting that it could produce as many as a billion units by the end of the first quarter of 2021. In this context, “at risk” means that the final design of the vaccine could change. J&J envisions a timeline where human trials could begin in September 2020, with emergency use approval to follow in early 2021. The company has partnered with US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) to provide $1 billion in funding for vaccine production and has committed to produce its vaccine candidate on a non-profit basis.

Published: April 14, 2020

Yahoo Finance

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Gilead shares slip as a second remdesivir COVID-19 trial is halted in China

Gilead Sciences has suffered what appears to be a setback in its efforts to test remdesivir as a potential treatment for COVID-19. In the past week two different trials, one for severe COVID-19 patients and another for mild to moderate ones, were suspended due to lack of participants. This follows some encouraging results from much smaller samples, including a 53 person study, and lab work at the University of Alberta.

Published: April 15, 2020

Fierce Biotech

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Fujifilm speeds production of potential COVID-19 therapy Avigan

Japanese company Fujifilm is rapidly scaling production of its influenza drug AVIGAN® (favipiravir) to meet demand as a potential COVID-19 treatment. The drug was originally developed and approved for use as a treatment for novel and re-emerging influenza in the event an outbreak occurs, and has never been dispensed to the general public in Japan or internationally. It is currently subject to a number of trials in Japan and around the world.

Published: April 15, 2020

Fierce Pharma

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China’s CanSino Bio advances COVID-19 vaccine into phase 2 of preliminary safety data

China-based CanSino Bio has disclosed in financial regulation documents that it intends to move a COVID-19 vaccine candidate to a phase 2 clinical trial “soon.” The development is lightning-quick by industry standards, as it has only been three weeks since the phase 1 trial concluded. Online enrolment is already available for this next phase. The trial will look at outcomes along three different timeframes: adverse reactions after 14 days; antibody levels after 28 days; and follow-up for up to six months.

Published: April 10, 2020

Fierce Pharma

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Two-thirds of acute coronavirus patients tested on antiviral drug improved

An early study of remdesivir as a treatment for hospitalized COVID-19 patients yielded some encouraging results, as more than two-thirds (68%) saw an improvement. In total, outcomes for 53 individuals spanning North America, Europe and Japan were tracked following a 10-day compassionate use course of the drug. More than half of patients initially needing mechanical ventilation resumed breathing on their own, and almost half of all patients were discharged from hospital. Thirteen percent of patients died, and mortality was highest among those on a ventilator. Additional trials are required before broader conclusions about remdesivir’s suitability as a COVID-19 treatment may be drawn.

Published: April 11, 2020

The National Post

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Samsung scores $362m deal to help Vir scale up COVID-19 antibody production

Vir Biotechnology and Samsung Biologics have agreed to a $362 million deal to scale up production of Vir’s monoclonal antibody program to potentially treat COVID-19. Vir is currently focused on two possible antibodies, VIR-7831 and VIR-7832, aiming for phase 2 clinical trials in a matter of months. The company has signed a number deals in the past several months to boost production if treatment is shown to be effective.

Published: April 10, 2020

Fierce Pharma

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Alexion plans phase 2 study of Soliris in COVID-19 in coming days: report

Alexion has announced plans to launch a Phase 2 trial of SOLIRIS® (eculizumab) to treat COVID-19 after some positive results in a smaller, ten patient proof-of-concept trial. The drug is currently used to treat a range of rare diseases related to the immune system, and researchers feel there is a rationale for testing it in COVID-19 patients. The trial is expected to start in a matter of days.

Published: April 7, 2020

Fierce Pharma

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Roche accelerates another Actemra trial for COVID-19

Roche received a significant financial boost from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to speed up the process of bringing ACTEMRA® (tocilizumab) to a phase 3 trial of COVID-19 patients. The $25 million grant is the next phase in the United States government’s commitment to test the drug, following expedited Food and Drug Administration (FDA) approval to begin earlier trial phases. Currently used to treat rheumatoid arthritis, it is thought to have potential to reduce the lung inflammation that characterizes severe COVID-19 cases.

Published: April 7, 2020

Fierce Pharma

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COVID-19 vaccine candidate shows potential, research shows

The University of Pittsburgh School of Medicine has developed a vaccine candidate that shows potential in trials with mice to neutralize the SARS-CoV-2, the coronavirus that causes COVID-19. The vaccine is delivered through a fingertip sized patch and researchers are in the process of obtaining regulatory approval to move into Phase 1 human trials.

Published: April 2, 2020

Science Daily

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Novartis, Incyte set to roll JAK inhibitor Jakavi into COVID-19 clinical trial

Novartis and their partner Incyte will be moving to a Phase 3 trial for JAKAVI® (ruxolitinib), testing whether or not it can reduce the lung complications that characterize most severe COVID-19 cases. The companies will also establish a compassionate use program for the drug, while protecting supplies for patients currently taking it for a range of inflammatory diseases and cancers.

Published: April 3, 2020

Fierce Pharma

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BD to offer fingerstick antibody test for COVID-19

BD is preparing to offer a fingerstick test to detect antibodies that show an immune response to COVID-19, with results within 15 minutes. The test has potential to help rule out COVID-19 in patients as well as determine possible immunity to the virus in individuals who have had mild or no symptoms. The test should be available in the month of April and BD plans to produce up to a million units.

Published: April 2, 2020

Fierce Biotech

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Gilead CEO says coronavirus hopeful remdesivir will be ‘affordable’ but it could still rake in revenue

Following widespread attention from reports of remdesivir showing potential to treat COVID-19 (covered in the March 31 COVID-19 DEW) Gilead Sciences CEO Daniel O’Day has committed to ensuring affordability and accessibility. In an open letter O’Day also outlined unprecedented amounts of remdesivir being made available through compassionate use programs and detailed plans moving forward to make that program more sustainable by focusing it on pregnant women and children while giving hospitals the option to make an application on behalf of critically ill patients. In Canada, remdesivir was previously available through Health Canada’s Special Access Programme but due to volume of demand, Canadians are now encouraged to seek enrolment in a clinical trial.

Published: March 30, 2020

Fierce Pharma

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Abbott receives FDA emergency use authorization for new COVID-19 test

The United States Food & Drug Administration (FDA) has given emergency use authorization to a COVID-19 test from Abbott that gives positive results in five minutes and negative results in 13 minutes. The test is portable, allowing for deployment as testing needs change and arise.

Published: March 30, 2020

ABC News

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Treatment of 5 critically ill COVID-19 patients with convalescent plasma

A case series from Shenzhen, China that focused on five critically ill COVID-19 patients previously on ventilation found clinical improvements in all patients approximately one week after being treated with convalescent plasma from other patients who had successfully recovered from COVID-19. Improvements were seen in the form of body temperature normalization, decreases in viral loads related to COVID-19 and increases in neutralizing antibodies. Four patients no longer required respiratory support after plasma transfusion. Due to the small sample size and uncontrolled study design, further clinical trials are needed before drawing larger conclusions.

Published: March 27, 2020

JAMA Network

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Remdesivir most promising COVID-19 drug, say researchers

A recently published survey of therapeutical developments related to COVID-19 suggests that the most effective treatments will prove to be those that target the SARS-CoV-2 virus responsible for COVID-19, namely remdesivir, which was developed by Gilead Sciences as a treatment for Ebola virus disease and Marburg virus infections, and tilarone. The review runs through more than 15 potential vaccines in development around the world and looks at other therapies just reaching the phase of trials in humans, such as blood transfusions between successfully recovered and critically ill patients. Here in Canada, while remdesivir was previously available under the Special Access Programme, that is no longer the case. Canadians are encouraged to seek access through clinical trials via Gilead Sciences.

Published: March 27, 2020

Drug Target Review

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FDA authorizes handheld COVID-19 test

Mesa Biotech’s Accula device received emergency approval from the FDA. The company has a record of producing similar products for influenza testing, which can be administered at medical facilities and potentially give results in 30 minutes.

Published: March 24, 2020

Fierce Biotech

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Top COVID-19 aspirants chloroquine, AbbVie’s Kaletra and a flu drug disappoint in clinical tests

Chloroquine/ hydroxychloroquine, KALETRA® (lopinavir/ritonavir) and ARBIDOL (umifenovir) produced suboptimal results in various clinical trials performed in China, slowing hopes that one of the drugs could be re-purposed to treat COVID-19 patients. That said, the drugs are expected to continue being trialed moving forward, including in a major World Health Organization initiative expected to involve thousands of patients.

Published: March 24, 2020

Fierce Pharma

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Roche launches clinical trial of COVID-19 pneumonia hopeful Actemra after backing from China.

An arthritis drug already included in the Chinese treatment guidelines for COVID-19 will soon face expanded testing in other countries, including the United States, to better establish its suitability before more widespread use. Beginning in early April, Roche’s ACTEMRA® (tocilizumab) will be compared to placebo to treat patients with severe COVID-19 pneumonia, following up on widespread interest in it after its early March approval in China.

Published: March 19, 2020

Fierce Pharma

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