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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
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
AstraZeneca is selling off limited rights to its former blockbuster statin drug Crestor to Grünenthal for $320 million upfront and possible future milestone payments of up to $30 million. 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