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Combination product agreement meetings — known within the FDA as CPAMs — are a prime way sponsors of such products can gather agency feedback on their applications, the agency said in a final guidance released yesterday. Read More
Novo Nordisk has announced that effective Jan. 1, it will stop distributing discounted medications to community-based pharmacies of covered entity hospitals under the 340B Drug Pricing Program, joining other drugmakers who have taken similar steps to combat what they claim are duplicate discounts created under the program’s expansion to include contract pharmacies. Read More
A group of pharma industry investors is pressing several leading drugmakers to make their COVID-19 treatments and vaccines both affordable and accessible. Read More
The UK’s Drug Safety Research Unit (DSRU) is gearing up to start an active surveillance study of COVID-19 vaccines following the country’s emergency clearance of Pfizer’s highly effective coronavirus vaccine, the group announced. Read More
Moderna is preparing to launch a new phase 2/3 trial in the U.S. to assess its promising coronavirus vaccine in adolescent participants aged 12 to 17, though it’s not yet clear when it will start enrolling volunteers. Read More
The U.S. government is exercising its option for an additional 650,000 doses of Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) for $812.5 million, following the drug’s Emergency Use Authorization (EUA) in November for mild-to-moderately ill COVID-19 patients at high risk. Read More
AstraZeneca’s (AZ) late-stage U.S. coronavirus vaccine trial is likely to have efficacy data in January that could be enough for the company to request Emergency Use Authorization (EUA), Operation Warp Speed’s chief adviser Moncef Slaoui said this week. Read More
The Commerce Department is requesting comments on the U.S. supply chain for essential medicines and on the wider public health “industrial base” and is providing an unusually short window for responses. Read More