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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
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
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
Teva Pharmaceuticals subsidiary Actavis Laboratories infringed upon five patents belonging to Tris Pharma by producing and marketing generic versions of Tris’s Quillivant XR, an extended-release liquid formulation of methylphenidate to treat attention deficit hyperactive disorder (ADHD), a federal court has ruled. Read More
President Trump has scheduled a COVID-19 vaccine summit for Dec. 8 with pharma executives, government leaders, scientific experts and others just days before an FDA advisory panel meets to discuss Emergency Use Authorization (EUA) for Pfizer’s vaccine candidate. Read More
In a watershed moment in the pandemic, the UK became the first Western nation to authorize a COVID-19 vaccine for emergency use, granting Pfizer clearance for its highly effective shot Wednesday, though the move drew immediate criticism from the EU. Read More
The White House called in FDA Commissioner Stephen Hahn for a meeting yesterday to discuss the pace at which the agency is moving to authorize Pfizer’s COVID-19 vaccine. Read More
HHS has elaborated on the government’s decision to do away with the Unapproved Drugs Initiative (UDI), a controversial program launched in 2006 that forced drugmakers to either remove unapproved drugs from the market or earn FDA approval for them by showing safety and efficacy. Read More
A whistleblower who alleged that AbbVie paid kickbacks to doctors to get them to prescribe Humira (adalimumab) had most of his claims tossed in federal court on Monday, except those relating to Florida, where he once worked promoting the drug. Read More
The European Commission (EC) and Gilead Sciences say EU member states aren’t obligated to pay for the up to 500,000 treatment courses of Veklury (remdesivir) negotiated under a joint procurement agreement with the company in October — and the commission says that the European Medicines Agency (EMA) may reconsider the conditional marketing authorization it granted for the drug in July. Read More
The European Medicines Agency (EMA) on Tuesday received emergency vaccine clearance applications from Pfizer and Moderna and said that it could approve the highly effective coronavirus vaccines within weeks, if the data support it. Read More
The Canadian government has issued an interim order to prevent the export to the United States of drugs that are in short supply north of the border. Read More