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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
The new head of the European Medicines Agency (EMA), Emer Cooke, said she is “hopeful” that the agency will grant a conditional marketing authorization for a COVID-19 vaccine by Christmas. Read More
The European Commission (EC) last week adopted an ambitious drug access strategy inspired by the COVID-19 pandemic that proposes allowing generics manufacturers to sidestep having to get patent permissions during public health emergencies. Read More
Sputnik V will be “two or more times cheaper than foreign vaccines based on mRNA technology with similar efficacy rates,” Russia’s sovereign wealth fund said. Read More
Financial terms of the EU contract were not disclosed, but Moderna CEO Stephane Bancel said the company planned to charge governments between $25 and $37 per dose. Read More