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Spectrum Pharmaceuticals, receiving yet another blow from the FDA on its cancer therapy candidate, poziotinib, has announced that it will drop its poziotinib program and is laying off 75 percent of its research and development staff. Read More
Axsome Therapeutics’ proprietary combination of dextromethorphan and bupropion — already approved for major depressive disorder as AXS-05 — also reduced the risk of agitation related to Alzheimer’s disease (AD), the company reported. Read More
Included in — then stripped out of — user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s accelerated approval (AA) and require more regular study progress updates from manufacturers. The proposals also sought to permit the FDA to require studies to be underway at the time the drug is approved, or prior to that time, and to allow use of real-world evidence to support the studies. Read More
Accelerated approval (AA) was catapulted directly into the public eye with the FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) 18 months ago on the shaky success of its surrogate endpoints — and the pathway has stayed firmly in the limelight ever since, facing increasing scrutiny from seemingly all quarters. Read More
The FDA has issued a warning letter to a Lake Forest, Calif.-based biologics company, Invitrx Therapeutics, for selling unapproved allogenic cellular-derived drugs, including a human umbilical cord-derived product. Read More
CSL Behring has won FDA approval for Hemgenix (etranacogene dezaparvovec-drlb), a gene therapy with the potential to cure hemophilia B and — at $3.5 million per treatment — the most expensive drug in the world. Read More