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Sen. Amy Klobuchar (D-Minn.) is calling on the Federal Trade Commission to investigate certain drugmakers for possible antitrust violations in light of recent drug price increases. Read More
Eight drugmakers have contributed more than $10 million in recent weeks, with Johnson & Johnson putting in more than half the total, to fight a proposed November 2016 ballot initiative in California that would cut state spending on prescription drugs. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
President Barack Obama late Wednesday signed into law a bill to compensate patients who participate in clinical trials involving rare diseases. Read More
Long-term efficacy data on two multiple sclerosis drugs — Novartis’ Gilenya and Sanofi’s Lemtrada — back their ability to keep relapsing MS at bay, while Roche’s investigational ocrelizumab performed well in both relapsing and primary progressive forms of the disease. Read More
The FDA last month awarded $19 million in research grants to boost the development of products to treat 17 different rare diseases, many of which have little or no available treatment options. Read More
The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiotics. Read More
The House Energy & Commerce Committee is once again demanding information on the status of all patients in NIH clinical trials affected by the shutdown of the agency’s drug compounding facility, despite receiving a letter from NIH saying there were no negative impacts on affected patients. Read More
President Obama’s nomination of Robert Califf to lead the FDA is drawing praise from those in industry and academia who see him as an outstanding choice and a strong leader deeply respected by the scientific community. Read More