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{ Category Archives: } COVID-19

Gilead to donate 300,000 more remdesivir doses to US hospitals

Gilead will increase the number of doses of remdesivir it’s donating to the federal government in the next six weeks, STAT reported. The drugmaker had planned to donate 607,000 vials of remdesivir — the drug that received FDA emergency approval for use in treating COVID-19 patients after it was shown to shorten recovery time in patients with the virus…

Infectious-disease doctors ask government to explain how it decides who gets Gilead’s remdesivir

Within a week of the Food and Drug Administration’s authorization of remdesivir as a COVID-19 treatment, clinicians are pushing the Trump administration to clarify how it is selecting which hospitals get access to the drug. Shares of Gilead Sciences Inc. GILD, +0.18%, which developed remdesivir, edged up 0.2% in Thursday trades and are up 19.4% in 2020. MORE…

Regeneron scales up manufacturing, eyes human tests of COVID-19 antibody cocktail in June

As COVID-19 ravages across the globe, Regeneron has responded with its own two-pronged approach against the disease. After early results in China showed inhibiting IL-6 could manage a potentially deadly immune overreaction in serious COVID-19 patients, Regeneron and partner Sanofi started a phase 2/3 trial of their rheumatoid arthritis therapy Kevzara, following a similar move…

Marketing COVID-19 is bad news for new drug launches. Which will suffer most?

The COVID-19 pandemic and the ensuing societal countermeasures are upending operations in many sectors—and biopharma isn’t immune. The current lockdown is not only hurting clinical trial enrollment but also delaying regulatory timelines for drugs nearing a decision. And with tried-and-true, in-person marketing techniques no longer allowed, new launches may also feel the pain—or hold off altogether. Consider Bristol…

Amgen teams up with Adaptive to both treat and prevent COVID-19

After The Wall Street Journal first broke the news this week, Amgen and new partner Adaptive Biotechnologies have confirmed they are the latest pharma-biotech duo joining forces against the pandemic. The pair, which said it will “start work immediately,” will develop fully human neutralizing antibodies targeting the COVID-19-causing virus, SARS-CoV-2, to potentially prevent or treat…

IL-6 to the rescue? Sanofi, Regeneron barrel ahead into another pivotal effort testing Kevzara for Covid-19

Sanofi and Regeneron have hustled up a second pivotal trial for their IL-6 drug Kevzara as a potential therapy for severe cases of Covid-19. The partners swiftly assembled a study drawing patients from Italy, Spain, Germany, France, Canada and Russia, planning to sign up 300 patients in a Phase II to test a low and…

Novartis, life sciences firms collaborate with BMGF to fight against COVID-19 disease

Novartis and a consortium of life sciences companies have collaborated with Bill & Melinda Gates Foundation (BMGF) to advance the development, manufacture and delivery of vaccines, diagnostics and treatments for COVID-19, the disease resulted due to the novel coronavirus SARS-CoV-2. Novartis, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, Pfizer,…

COVID-19 prompts Pfizer to stop enrollment in most studies

Pfizer has paused enrollment in many new and ongoing clinical trials in response to the COVID-19 pandemic, Reuters reports. The action sees Pfizer join Bristol Myers Squibb and Eli Lilly on the list of Big Pharma companies to revise their R&D plans in light of the novel SARS-CoV-2 coronavirus. Each company has responded slightly differently to…

FDA authorizes CPAP machines and more as emergency ventilator alternatives

The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators as shortages begin to impact hospitals’ responses to the coronavirus pandemic. This includes modified anesthesia gas hardware and positive-pressure breathing devices as well as home continuous positive airway pressure machines used to treat sleep apnea, portable oxygen generators…

Gilead halts emergency access to COVID-19 contender remdesivir amid ‘overwhelming demand’

Since the early days of the current coronavirus outbreak, Gilead Sciences’ experimental antiviral drug remdesivir has been hailed as a leading hope. That halo has apparently overwhelmed the Big Biotech. Gilead has temporarily stopped granting patients emergency access to remdesivir under compassionate use due to an “exponential increase” in requests over the last few days,…