An appeals court Wednesday overturned a federal court ruling that GlaxoSmithKline was liable for the suicide of an attorney who took a generic of its antidepressant drug Paxil (paroxetine). Source:…
Cancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse—and patients and researchers should be told if…
The FDA issued a warning letter to Hangzhou Karic Commodities and placed it on an import alert after an inspection of its Hangzhou, Zhejiang facility revealed numerous violations, including a…
Sen. Edward Markey (D-Mass.) is urging the FDA to overhaul the risk evaluation and mitigation strategy (REMS) program. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb announced Wednesday that the agency is hiring the National Academies of Sciences, Engineering and Medicine to help develop guidelines for opioid analgesic prescribing. Source: Drug Industry…
The FDA is asking stakeholders to suggest structural endpoints for use in trials of medical products aimed at treating the root cause of osteoarthritis. Source: Drug Industry Daily
Citing data integrity concerns, the FDA hit Kyowa Hakka Bio with another warning letter for repeat violations at its Hofu, Yamaguchi facility. The agency issued a previous warning to the…
Under a voluntary initiative set to take effect this month, Oklahoma will introduce value-based drug purchasing for Medicaid, only fully compensating manufacturers of drugs that deliver the promised results. Source:…
CVS and Rite Aid filed an antitrust suit accusing AbbVie of mounting “sham” patent lawsuits against two generic manufacacturers to protect its testosterone replacement drug AndroGel from competition. Source: Drug…
In the first 100 days since the Trump administration issued its American Patients First blueprint, 15 drug companies have cut list prices, reversed planned price hikes or called for price…