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The House and Senate are expected to vote today on a combined fiscal 2021 appropriations and COVID-19 relief legislative package after passing another stopgap spending bill Sunday to keep the federal government funded for 24 hours. Read More
The import, sale and marketing of a competitor to AbbVie’s Botox wrinkle treatment must be stopped for nearly two years, the U.S. International Trade Commission (ITC) ruled this week. Read More
In a Thursday hearing of a congressional committee, two members of the Sackler family and Purdue Pharma’s current president and CEO, Craig Landau, dutifully expressed sorrow for the role played by Purdue’s former flagship product, the painkiller OxyContin (oxycodone), in the opioid abuse crisis that has killed thousands of Americans. Read More
With COVID-19 cases surging across Europe, EC President Ursula von der Leyen announced yesterday that EU countries will start vaccinations with the two-dose Pfizer/BioNTech vaccine on Dec. 27. Read More
Before proceeding with trials that use complex innovative designs (CID), sponsors should meet with the FDA to discuss their plans, according to a final guidance released Wednesday that provides details on the kinds of information to bring to an agency meeting. Read More
A final guidance released yesterday indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Read More
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-4 on Wednesday, with one abstention, that findings from a study sponsored by the National Institutes of Health (NIH) could support new heart failure indications for the generic drug spironolactone. Read More
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 12-1 yesterday that study data presented by Novartis to support a new indication for its blockbuster heart failure drug Entresto (sacubitril/valsartan) provided enough evidence. Read More
The European Medicines Agency (EMA) said it will complete its review of the Pfizer/BioNTech COVID-19 vaccine by Dec. 21 — a week ahead of schedule — and the EU is poised to grant emergency approval by Dec. 23, allowing vaccinations to begin by year’s end. Read More
Over two dozen state attorneys general penned a letter to HHS Secretary Alex Azar this week urging him to levy fines against a number of big pharma companies that have refused or threatened to refuse 340B drug discounts to contract pharmacies. Read More