The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016… Read More »Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data
The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance,… Read More »FDA issues Covid-19 vaccine guidance as White House reportedly relents
Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work… Read More »BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2
While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.
The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.
The company said that those who received the two-antibody cocktail REGN-COV2 showed a lower viral loads and faster alleviation of symptoms than those who received placebo.
The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar… Read More »AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19
Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting
The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.
Shots: Qiagen reports the launch of the Access Anti-SARS-CoV-2 Total test that runs on a portable device and provides accurate results on Total Ig Abs (IgA, IgM, IgG) in 10mins. The device can process up to 8 samples simultaneously or up to 32 tests/hour The… Read More »Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA… Read More »Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.
While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science… Read More »FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy
Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19
Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.
The companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.
Doctors have called for rules to be tightened on coronavirus antibody tests in the UK amid fears that false readings could put the public at risk. It’s not even known for sure that having antibodies against the SARS-CoV-2 coronavirus confers immunity. But with many other… Read More »UK doctors call for tighter rules on coronavirus antibody tests
An overview of various aspects of the supply chain that would be crucial in the production and distribution of COVID-19 Vaccine. Write to us at [email protected] if you want a PDF copy of this report. Over the past seven months, the global pandemic caused by… Read More »ViewPoints: COVID-19 Vaccine Distribution the Next Supply Chain Frontier
The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.
The deal brings Roche’s considerable manufacturing heft to Regeneron’s efforts to develop the two-antibody cocktail, REGN-COV2. Regeneron will distribute the drug in the U.S., while Roche will distribute it ex-U.S.
Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses? This is a question that a consortium of European pharma companies hopes to answer as it aims to rapidly develop new therapies to combat the pandemic. The Corona Accelerated… Read More »Could AI avert a future coronavirus pandemic?
Earlier this month, Ohio Gov. Mike DeWine received a false-positive result from a rapid antigen test for Covid-19, raising concerns about the tests’ accuracy. The assay’s maker, Quidel, said it is investigating the case.
The company plans to train 250 new racially and ethnically diverse clinical trial investigators and extend the reach of its trials to underserved rural and urban communities.
In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.
The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.
Russian President Vladimir Putin said a vaccine developed at a Moscow research institute that appears to still be in Phase I development among fewer than 100 participants had undergone all necessary tests.
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.
Shots: The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments… Read More »Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization
The drug has consistently failed to show a benefit when tested in randomized, controlled clinical trials. Social science may explain why laypeople and doctors alike continue clinging to it.
Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.
Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.
Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.
The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.
The company said that the COVACTA trial of Actemra in Covid-19 pneumonia had failed to meet its primary endpoint. Earlier this month, Regeneron and Sanofi announced that their study of a similar anti-inflammatory drug had also not met its primary endpoint.
The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.
The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named… Read More »Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial
A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab. The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483… Read More »Moderna gets further $472m as expanded phase 3 COVID-19 trial begins
The study adds to the growing body of evidence that the drug, promoted early in the pandemic by President Trump, is ineffective, despite its getting a briefly renewed lease on life earlier this month thanks to a retrospective analysis.
MedCity spoke with Evidation and BrightInsight, two startups that have recently announced funding rounds, amid a Covid-19 pandemic worsening in the U.S.
The company said the CareStart Covid-19 MDx RT-PCR test is designed to detect RNA from the SARS-CoV-2 virus and produce results within 83 minutes.
The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are… Read More »Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine
“Everybody’s an infectious disease company now,” ARCH Venture Partners Managing Director Bob Nelsen said. By contrast, a report last year showed a huge decline in venture capital investment in the infectious disease space.
The company said that patients receiving the drug, SNG001, had a 79% lower risk of requiring ventilation or dying compared with those on placebo, sending the company’s stock soaring more than 400%, but it did not clarify what that meant in terms of patient numbers.
The company announced the publication of interim data from the Phase I/II study of a vaccine it is developing with the University of Oxford. The news comes the week after Moderna announced the publication of data for its vaccine.
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The Beijing company said it selected the United Arab Emirates because of its ethnic diversity, which will enable it to determine the feasibility of taking its program global. It claims that its study is the first Phase III inactivated vaccine trial, but another Chinese firm… Read More »Sinopharm launches Phase III trial of inactivated-virus vaccine in Abu Dhabi
A joint report by cybersecurity agencies in the U.K. and Canada, endorsed by their U.S. counterparts, states that the hacker group Cozy Bear had been targeting organizations involved with Covid-19 vaccine development efforts.
Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.
The companies anticipate releasing more clinical data from the BNT162 messenger RNA vaccine program and potentially starting a 30,000-participant Phase IIb/III study this month.
The study is enrolling 60 healthy volunteers aged 18-45, but the company hopes it will form the basis of trials of the drug as an outpatient treatment for patients who do not require hospitalization. Remdesivir is currently administered via IV.
Research on the drug’s molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.
The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine to do so.
The NIAID create the Covid-19 Prevention Trials Network by combining four existing ones, primarily focused on HIV and AIDS, which will continue that work in addition to their new focus on Covid-19.
The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.
The company is running a Phase I/II study that started in May in Australia and plans to open a Phase III study of its vaccine candidate, NVX-CoV2373, that will enroll up to 30,000 participants starting in the fall.
Researchers in Spain, one of Europe’s worst-hit countries, randomly selected more than 61,000 people, but found that even in places with high infection rates like Madrid, relatively few people tested positive for antibodies against SARS-CoV-2.
The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.
Since the spread of COVID-19 was first reported, researchers of all types have mobilized to meet the challenges its causative agent, SARS-CoV-2, presents to the world. Data scientists in particular have been quick to apply their expertise to the problems of identifying, tracking and predicting… Read More »The FAIR Toolkit Helps Researchers with Data Challenges
Drug development is a multidisciplinary field that requires a drug to successfully pass through different stages — from chemical design to biological experimentation on cells and animals, and finally three phases of human clinical trials — before being approved by the FDA for clinical administration.… Read More »Drug Repurposing for SARS-CoV-2 Using Network Polypharmacological Approach
Coronavirus: 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic
Today I am going to share some important ways that doctors, hospitals and healthcare marketers can use social media to inform the public during the COVID-19 crisis. Priority One: Use social media to convince people to comply with social distancing, and consequently help us all,… Read More »Coronavirus: 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic