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The Biden administration yesterday launched a $3 billion program to develop antiviral medicines for treating COVID-19 and confronting future pandemics. Read More
Biogen has launched a phase 3 trial of its monoclonal antibody, BIIB059, a potential blockbuster that has shown promise for treating individuals suffering from lupus, a chronic and debilitating autoimmune disease. Read More
Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz (tofacitinib) reduced the incidence of death or respiratory failure among hospitalized patients with COVID-19 pneumonia in a Brazilian study. Read More
CureVac’s much-anticipated messenger RNA-based COVID-19 vaccine, CVnCoV, was only 47 percent effective at preventing symptomatic disease in a sizable trial at its interim analysis, missing success criteria. Meantime, Europe has pre-ordered 225 million doses of the vaccine, which may not achieve regulatory authorization. Read More
The FDA has approved a third batch of Johnson & Johnson (J&J) COVID-19 vaccine drug substance for release from the embattled Emergent plant in Baltimore, Maryland — but still hasn’t authorized the Bayview facility to resume production. Read More
A proposed regulatory science pilot program and the FDA’s cost estimates under the next iteration of the Biosimilar User Fee Act (BsUFA) program were the focus of discussions in a recent negotiation meeting. Read More
The U.S. and EU reached an agreement to reduce export restrictions for COVID-19 vaccines and therapeutics at a Tuesday summit meeting in Brussels. Read More
Civica Rx, a two-year-old nonprofit organization launched to address generic drug shortages in the U.S., announced that drugmaker Catalent and health insurance giant Anthem are joining the organization’s new CivicaScript operating unit that focuses on making generic drugs. Read More