Amneal Pharmaceuticals
NEWS
Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.
Regeneron envisions new dosing for Eylea’s label and it’s the moment of truth for BioMarin’s gene therapy for hemophilia A. For that and more, see inside.
Between new formulations of traditional drugs nearing the market and completely novel approaches in mid-stage trials, 2023 is poised to be a pivotal year in Parkinson’s disease treatment.
ImmunityBio is laying off 38 employees at its Dunkirk site in New York, Amneal will shutter a Long Island facility and Rigel culls 30 employees following wAIHA regulatory decision.
Amneal Pharmaceuticals received the green light from the U.S. Food and Drug Administration for bevacizumab-maly, a biosimilar to Genentech (Roche)’s Avastin.
Releuko is expected to launch in the third quarter of 2022 as a treatment for neutropenia, a low white blood cell condition experienced by chemotherapy patients.
In the pivotal Phase III trial, Amneal’s investigational Parkinson’s drug, IPX-203, met its primary endpoint, demonstrating superior “Good On” time in patients with motor fluctuations.
Kaiser Permanente has reportedly filed a lawsuit against drug maker Merck for allegedly allowing a “pay-for-delay” scheme that cost the former millions of dollars.
Two weeks after announcing concerns about high-levels of carcinogens in popular diabetes drugs, the U.S. Food and Drug Administration announced the first voluntary recalls of this class of drugs manufactured by five companies.
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