Atea Pharmaceuticals Inc.’s experimental Covid-19 antiviral pill being developed with Roche failed to help patients with mild and moderate Covid-19 in a small study of mostly low-risk patients, driving the Boston-based drugmaker’s shares down more than 65 percent on Oct. 19.
The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
A late-stage trial of Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) failed to reach the study’s main goal, but secondary measures and biomarkers showed favorable trends, the company said on Oct. 17.
Roche’s Ocrevus treatment showed fewer patients with relapsing multiple sclerosis needed walking aids, the company said on Oct. 13
According to a Wall Street Journal report, the preferred Covid-19 shot globally is the Pfizer-BioNTech vaccine.
The U.S. Food and Drug Administration awarded Roche’s Alzheimer’s disease drug candidate Breakthrough Therapy Designation, bringing the IgG1 antibody gantenerumab closer to finally receiving full FDA approval.
To keep the company’s pipeline full of promising new treatments over the long term, Amgen continues to invest in building a set of differentiated early research capabilities.
Acting U.S. Food and Drug Administration Commissioner Janet Woodcock’s days as interim head of the regulatory agency are numbered due to federal regulations. Not only does President Biden have to appoint a new FDA commissioner, he will also need to tap a new head of the National Institutes of Health (NIH) following the retirement announcement of longtime director Francis S. Collins, M.D., Ph.D.
Fresh out of the gates with $500 million in financing, neuroscience-focused Neumora Therapeutics forged a strategic partnership with Amgen to develop and commercialize assets owned by the pharma giant, targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases.
Pfizer Inc. and BioNTech SE asked U.S. regulators to authorize emergency use of their Covid-19 vaccine for children ages 5 to 11, a group for whom no shot is allowed, Pfizer said on Oct. 7.