Topic:

Regulatory

Latest Headlines

Latest Headlines

Lilly grabs a 'tentative' FDA OK for insulin treatment, but Sanofi still blocks its path

Eli Lilly has won a "tentative" FDA approval for its knockoff of Sanofi's Lantus, but don't look for it at a pharmacy anytime soon. The insulin glargine injection--to be marketed as Basaglar eventually in the U.S.--faces an automatic 30-month stay after Sanofi filed a suit against Lilly and its partner Boehringer Ingelheim claiming patent infringement.

Sun Pharma recalls nearly 500,000 bottles of antibiotics

After releasing an earnings report that showed strong growth in the U.S., India's Sun Pharmaceuticals is recalling nearly 500,000 bottles of antibiotics, a fourth recall since announcing its $4 billion deal to buy compatriot Ranbaxy Laboratories and fix its ongoing quality faux pas.

Pfizer hands in an early application for the blockbuster contender palbociclib

As expected, Pfizer has submitted an early FDA application for palbociclib, beating a quick path to market with a breakthrough breast cancer treatment that could peak at nearly $3 billion a year.

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.