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The FDA said Wednesday that its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
An obesity candidate linked to patient deaths during a clinical trial last year may have a potential path forward after its sponsor revealed that it met its co-primary endpoints in a Phase 3 study. Read More
The FDA’s chief watchdog for drug promotion — the Office of Prescription Drug Promotion — issued its first untitled letter of the year, blasting Hospira for running an online video that omitted multiple required disclosures. Read More
Boehringer-Ingelheim has to hand over settlement papers to the FTC after the U.S. Supreme Court rejected the company’s assertion that the documents are protected communications. Read More
Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes. Read More
Patient in French Study Dies, Others Improving
FDA Fast Tracks Zogenix Candidate in Rare Disease
Abbott's Compounding Pharmacy Recalls Products Over Lack of Sterility Assurance
Investigative Allergic Conjunctivitis Treatment Flops Read More
Merck has agreed to pay $830 million to settle claims that it failed to inform investors of the heart risks related to its Vioxx pain medication, which is now discontinued. Read More
The U.S. Supreme Court has refused to hear Johnson & Johnson’s appeal of an unfavorable ruling in a negligent labeling case, a decision that will cost the company $140 million. Read More
The European Commission has blessed the first biosimilar of Amgen’s blockbuster drug Enbrel, clearing the way for Samsung Bioepis to release the biosimilar in select EU countries in the coming weeks. Read More
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More