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Gilead Sciences has downgraded its development pact with Belgian drugmaker Galapagos after deciding to no longer pursue FDA approval for its rheumatoid arthritis (RA) drug Jyseleca (filgotinib). 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
Moderna has revealed that it was impacted by last week’s cyberattack on the European Medicines Agency (EMA), during which hackers compromised agency computer systems and accessed vaccine regulatory submission documents for Pfizer/BioNTech’s and Moderna’s COVID-19 vaccines. 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 FDA’s vaccines advisory committee will meet tomorrow to discuss Moderna’s two-dose COVID-19 vaccine and is expected to vote in favor of Emergency Use Authorization (EUA) from the agency. 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