Cliodhna McDonough-Stevens looks at what the COVID-19 pandemic might mean for the future of cell and gene therapy across Europe. … [Read more...]
Magenta’s AML and MDS Drug Trial Put on Hold
The FDA has asked the company to develop an additional bioassay to inform dose escalation decisions and safety monitoring. … [Read more...]
Pfizer/BioNTech’s BLA Gets Priority Review Designation From FDA
The FDA has granted priority review designation to Pfizer’s and BioNTech’s Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in people 16 years of older. … [Read more...]
ICER Panel Reviews the Aduhelm Roller Coaster: Says it’s Not Worth the Ticket Price
How do you determine a drug’s cost/benefit ratio when you know the cost to procure and administer it could soar to $100,000 each year, but the benefit could be zero? … [Read more...]
Pfizer Agrees to Pay $345 Million to Settle EpiPen Lawsuit
Pfizer has agreed to a $345 million settlement of a class action antitrust suit over the EpiPen, an epinephrine auto-injector used in the emergency treatment of anaphylaxis. … [Read more...]