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The FDA will allow sponsors to extrapolate efficacy results from adult studies to use in pediatric studies of anti-infective drugs, as long as the disease process and the effects of the drug are similar in both populations. Read More
The FDA issued Intercept Pharmaceuticals a complete response letter for its investigational drug, obeticholic acid (OCA), for liver fibrosis due to nonalcoholic steatohepatitis (NASH). Read More
The University of Oxford is ready to launch a phase 3 trial in Brazil of AstraZeneca (AZ)’s COVID-19 vaccine candidate, considered by the World Health Organization (WHO) to be the frontrunner in the research race. Read More
After weeks of waiting, Gilead Sciences announced yesterday that it will charge U.S. insurers $3,120 for a six-vial, five-day course of remdesivir, and a lower price of $2,340 for governments of developed countries, including the U.S. Read More
Novartis has agreed to pay $345 million to the U.S. government to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) by bribing doctors in Greece and Vietnam. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight drugs for approval, including Vertex Pharmaceuticals’ triple combination therapy for treatment of cystic fibrosis. Read More
The FDA hit AbbVie with a complete response letter (CRL) for abicipar pegol, its investigational drug for treatment of wet age-related macular degeneration. Read More
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with the Stevanato Group to help solve a serious problem facing vaccine manufacturers as they scale up production — a global shortage of glass vials. Read More
China has approved phase 1 trials of a COVID-19 vaccine candidate being developed by the country’s military in collaboration with two Chinese companies. Read More