Ever since the FDA drafted a set of rules for biosimilars in 2012, a debate has been raging over whether those drugs should carry the same generic names as the products they emulate. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have different names than branded biotech drugs.
Danish financial regulators took a dim view of Novo Nordisk's decision to spend the weekend pondering the FDA's February 2013 snub to Tresiba before spreading the news of the agency's complete response letter and the major delay that would be triggered by its demand for a new study. And today Novo said it had decided to accept a $90,000 fine to close the books on the incident, not the least bit chastened at the slap on the hand.
The Alabama Supreme Court won't back away from a controversial ruling against Pfizer, in a liability case closely watched by the rest of the pharma industry.
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U.K.'s National Institute for Health and Care Excellence has delivered a blow to Johnson & Johnson's Zytiga in final draft guidance recommending against the prostate cancer pill as a treatment for prostate cancer before chemotherapy.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.