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The FDA has slapped hair and skincare products maker Alikay Naturals with a warning letter that takes the company to task for the presence of lead in one of its products. Read More
Health insurer Anthem is suing Express Scripts in federal court for nearly $15 billion, claiming that the PBM has overcharged and is refusing to renegotiate future drug prices. Read More
Valeant Begins CEO Search, Adds Ackman to Board
Hospira Plagued Again by Particulate Matter in Injectables
Court: Mylan Must Face Patent Suits in Delaware
Amgen, UCB’s Osteoporosis Candidate Meets Primary Endpoint in Phase 3
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Johnson & Johnson and Novartis each scored a victory in the UK, with the National Institute for Health and Care Excellence backing their respective treatments for prostate cancer and heart failure. Read More
The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
Days after the European Medicines Agency launched an investigation into Gilead’s Zydelig, the agency’s Pharmacovigilance Risk Assessment Committee now is recommending the drug be taken with antibiotics to prevent pneumonia. Read More
The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More
Small drugmaker Fabre-Kramer Pharmaceuticals won a big victory Thursday after the FDA ignored its own internal advisory committee recommendations and negative determinations by the Office of New Drugs’ Office of Drug Evaluation I. Read More
The FDA put a damper on Eagle Pharmaceuticals’ plans to market its blood thinner Kangio via a complete response letter not recommending approval. Read More