Topic:

Regulatory

Latest Headlines

Latest Headlines

When is 5 years not 5 years? When it's the FDA counting, Eisai claims

What makes a 5-year exclusivity period? Under U.S. law, it's the 5 years after FDA starts the clock ticking. Eisai has no qualms about that. But the Japanese drugmaker says the agency started that clock much too soon for two of its products--and it's suing the FDA to change that.

Sanofi wins FDA's blessing for an oral Gaucher drug

Sanofi's rare ailment-focused Genzyme unit won FDA approval for a new Gaucher disease treatment, providing an oral alternative to its own trailblazing intravenous therapy.

Mist formulation of Boehringer Ingelheim's COPD inhaler gets advisory committee nod

The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-3 to recommend approval of Boehringer Ingelheim's mist formulation of its dry-powder inhalable treatment for chronic obstructive pulmonary disease.

Lilly, Boehringer score FDA backing for Lantus copy, but patent fight awaits

Eli Lilly won't be able to sell its Lantus copycat--dubbed Basaglar--for at least 30 months because of a patent fight with Sanofi.

UPDATED: FDA warning letter says Marck plant plagued by faked records and dead frogs

The FDA in March issued an import alert against a Marck Biosciences sterile manufacturing plant in Kheda, India. A July warning letter posted today explains why. Employees recorded data for functions that were not performed. Records, if kept at all, were often put on "scratch paper." The bathroom was filled with mold and an exit loading dock was littered with dead and decaying frogs.

DOJ clears AstraZeneca for a U.S. Brilinta takeoff

The U.S. Department of Justice closed out its probe of a key Brilinta trial--and without further ado. No additional label warnings. And certainly no forced withdrawal from the U.S. market.

Big investors urge drugmakers to stop badmouthing biosimilars

As the FDA considers whether it should approve recently filed biosimilar versions of Johnson & Johnson's Remicade and Amgen's Neupogen, a parade of pharma companies, physicians and payers is coming forward to voice their concerns, not the least of which is how these products will be named. Now another group of concerned parties has joined the chorus: investors.

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.