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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…

Compass raises $80M to take magic mushroom drug toward phase 3

Compass Pathways has raised $80 million to prepare its psilocybin therapy for phase 3 development. The London-based biotech is advancing the drug, the active ingredient in magic mushrooms, for use in people with treatment-resistant depression. Psilocybin was studied in the 1960s, but research ground to a halt over the following decades. Teams at academic centers including the…

$5.5 billion stem cell initiative facing rocky road

Backers of a $5.5 billion stem cell research proposal in California today have once again missed a self-imposed, but critical deadline as they continue to struggle with securing enough signatures to place the measure on the November ballot. The campaign’s website this morning listed what is now its third deadline for gathering the signatures of…

DEA Removes CBD from Controlled Substances Act

On Monday, April 6, GW Pharmaceuticals revealed that the company had received notice from the U.S. Drug Enforcement Administration (“DEA”) stating that its drug Epidiolex was no longer subject to the requirements of the Controlled Substances Act (“CSA”). In a company release announcing the agency decision, GW CEO Justin Gover stated, “This notification from DEA fully establishes…

BrainStorm Awarded $1.5M Non-Dilutive Grant for 2020 by the Israel Innovation Authority

NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA). The grant…

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,…