An FDA panel today advised the agency against requiring more large clinical studies for the cardiovascular risks of drugs that treat opioid-induced constipution, relieving drugmakers like AstraZeneca, Salix Pharmaceuticals and others from bearing the burden of further clinical safety trials.
The FDA has announced it will vote this week on whether a class of drugs that treat opioid-induced constipation needs more clinical testing in light of a side effect: heart attack. The class of drugs includes recently approved products from Salix Pharmaceuticals and Cubist Pharmaceuticals but also one that AstraZeneca is developing with Nektar Theraputics.
Good news came for GlaxoSmithKline ($GSK) Tuesday after the FDA's Oncologic Drugs Advisory Committee voted 11 to 2 in favor of approving Votrient to treat patients with advanced soft tissue sarcoma who have received prior chemotherapy. The FDA approved Votrient in 2009 to treat advanced renal cell carcinoma.
The FDA advisory panel reviewing a new indication for Merck's ($MRK) cholesterol fighter Vytorin gave the drug a nod for preventing cardiovascular problems in patients with kidney disease, but voted
What to do about the potential risks of bisphosphonates? An FDA advisory panel wasn't exactly sure. At a meeting last week, the agency's expert committee voted to change the labeling on these popular
Boehringer Ingelheim may well have started celebrating earlier this week when the FDA gave a black eye to Bayer ($BAYN) and Johnson & Johnson's ($JNJ) potential competitor to its anticoagulant
The FDA's plan to reconsider conflict-of-interest rules governing its advisory-panel experts is drawing fire from the Project on Government Oversight, which argues that the regulations should not be
Experts speaking on behalf of Roche/Genentech's Avastin for use in breast cancer patients won't be required to disclose financial ties after the presiding officer of next week's hearing on the issue
New questions about the efficacy of Abbott's Trilipix drug weren't strong enough to inspire a thumbs down from an FDA advisory panel. The agency's committee of experts recommended in a 9-to-4 vote
Get ready for more controversy over Abbott Laboratories' (NYSE: ABT) diet pill Meridia. Two weeks before an FDA advisory panel meets to consider the drug's safety, final data from a long-term,