Topic:

Regulatory

Latest Headlines

Latest Headlines

Biogen ready to steal market share with newly minted MS drug Plegridy

Biogen Idec has added another bow to its multiple sclerosis quiver. With the FDA's approval of Plegridy, a long-acting form of its popular Avonex, Biogen can fight for an even bigger share of the MS market.

Docs to FDA: Biosimilars should have different names than branded drugs

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.

Novo Nordisk accepts a $90K slap on the hand for delaying news of Tresiba setback

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.

Alabama Supreme Court redux: Pfizer can be sued for generic Reglan harms

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.

Struggling Eisai files its thyroid cancer drug lenvatinib in U.S., EU

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.

Biogen scores fresh MS advance with blockbuster Plegridy OK

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 fends off Roche as hep C heavyweights fight for blockbuster rights

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.

FDA approves ear inserts to reduce TMJ pain

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.

NICE Zytiga snub is 'plainly illogical,' critic says

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.

Top U.S. senator urges Hospira to abandon inversion plans

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.