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In a widely reported interview over the weekend, FDA Commissioner Stephen Hahn said the agency is prepared to issue an Emergency Use Authorization for a COVID-19 vaccine before phase 3 trials are complete if the benefits outweighed the risks. Read More
The FDA has been accused of potentially fouling up its Aug. 23 Emergency Use Authorization (EUA) of convalescent plasma (CCP) for the treatment of COVID-19 by adding a requirement that each unit of plasma include information on the concentration of antibody titres. Read More
The European Commission announced Monday that it is participating in the World Health Organization’s international COVAX program for COVID-19 vaccines and is contributing $478 million. Read More
In applications for patents — including some generally relevant to its COVID-19 vaccine candidate — Moderna failed to disclose millions of dollars it got from the Defense Advanced Research Projects Agency (DARPA), alleges an advocacy group that wants the Department of Defense (DOD) to investigate. Read More
Nestlé has announced that it will acquire Aimmune Therapeutics for $2.6 billion in a deal that will add Palforzia — the first FDA-approved treatment for patients with peanut allergy — to Nestlé’s pharmaceuticals portfolio. Read More
GlaxoSmithKline failed yesterday to convince an FDA advisory committee that it should be allowed to add study data showing a reduction in mortality to the label of its chronic obstructive pulmonary disease (COPD) drug Trelegy Ellipta. Read More
GlaxoSmithKline and Vir Biotechnology have dosed the first patient in a phase 2/3 clinical trial of their investigational COVID-19 antibody treatment VIR-7831 for early treatment in patients at high risk of hospitalization. Read More