Still suffering from the loss of patent protection on its big Alzheimer's drug Aricept, Japan's Eisai said today that the company had fired off a pair of applications for its new cancer drug to U.S. as well as European regulators.
Billing it as the most important new innovation in the interferon drug class in a decade, Biogen Idec nailed down the FDA's approval of Plegridy, a new multiple sclerosis drug that patients can easily inject themselves with once every two weeks.
Gilead Sciences convinced an panel of arbitrators that rival Roche had no legitimate claims on Sovaldi, its record-setting hepatitis C treatment, but the antiviral pioneer still faces patent spats with a host of challengers looking to cash in on next-generation combo therapies for the disease.
The FDA has approved TMJ NextGeneration, custom ear canal inserts that increase the volume of the ear canal when the jaw is closed, thereby discouraging the user from clenching the jaw and the surrounding muscles.
U.K.'s National Institute for Health and Care Excellence has delivered a blow to Johnson & Johnson's Zytiga in final draft guidance recommending against the prostate cancer pill as a treatment for prostate cancer before chemotherapy. And nobody seems very happy about it--including NICE itself.
Amid growing regulatory action to crack down on corporate tax inversions, a top U.S. senator is urging Hospira to keep its operations at home and abandon plans to move abroad for taxpaying purposes.
After promising last month to fast track its review of Roche's Avastin in cervical cancer, the FDA has come back with a positive verdict--a full two months before its deadline. The agency approved the blockbuster drug to be used in combination with chemotherapy in women with advanced cervical cancer.
Medical device evaluation can only be as effective as the tools used to conduct the evaluation. The FDA has begun seeking applications for the Medical Device Development Tools Pilot Program to validate and review such tools in preparation for a final guidance on the topic.
Pfizer's Prevnar 13, the world's best-selling vaccine, scored a big win Wednesday, nabbing a CDC committee nod for universal use in adults over the age of 65. And once payer coverage kicks in, that's a nod that could be worth $2 billion for Pfizer, analysts say--with Merck's Pneumovax getting a boost, too.
With the FDA insisting on more studies before it will consider approval of its new antibiotic and needing money to pay for them, Switzerland-based Basilea figures it might sell some assets to raise the money.