The European Union’s drug regulator on November 19 advised that an experimental Covid-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.
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The U.S. Food and Drug Administration on November 19 authorized booster doses of Pfizer Inc. and BioNTech SE’s Covid-19 vaccine for all adults, a move aimed at addressing waning protection among fully vaccinated Americans in the face of Delta variant-driven breakthrough cases of the illness.
Moderna Inc. said on November 19 the U.S. Food and Drug Administration extended the emergency use authorization of a booster dose of the company’s Covid-19 vaccine to all adults aged 18 and older.
Gilead Sciences Inc. announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA.
The U.S. health regulator extended the review of Bristol Myers Squibb’s oral heart disease drug candidate mavacamten, which the company acquired in its $13 billion buyout of MyoKardia during 2020.
Germany’s BioNTech on November 19 was awarded fast track designation by the U.S. Food and Drug Administration for the speedy review of a novel skin cancer therapy, which is based on RNA technology similar to the one that underpins the company’s Covid-19 vaccine.
BridgeBio Pharma secured credit assistance worth as much as $750 million to move forward with the company’s research and development efforts for the treatment of cancers and genetic diseases.
Gilead Sciences exercised options to three of Arcus Biosciences’ programs, and the two companies also added a research collaboration deal.
Sanofi is investing in French American startup Owkin to support drug discovery and development initiatives in four types of cancer.
AstraZeneca on Thursday cemented the company’s lead in bringing a preventative Covid-19 shot to market, saying its antibody cocktail offered 83 percent protection over six months, another possible weapon in the fight against the pandemic.