Advisory panels

Latest Headlines

Latest Headlines

FDA panel advises against more clinical trials for opioid constipation drugs

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.

FDA to vote on opioid-induced constipation pills

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.

FDA panel backs GSK's Votrient for soft-tissue sarcoma

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.

FDA panel approves outcomes claim for Vytorin

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

FDA panel wants bone drugs' labeling changed, but how?

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

Even if FDA approves Xarelto, Pradaxa could still gain

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

Government watchdog attacks FDA conflicts plan

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

Roche experts won't have to disclose financial ties at Avastin meeting

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

FDA panel favors Trilipix combo, but asks for trial

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

NEJM fuels calls to withdraw Abbott's Meridia

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,