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Rapport COVID-19 DEW, propulsé par Reformulary® - Lire la suite

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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: July 29, 2020

Canada
International

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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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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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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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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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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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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