Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: Hospira says it will whack its U.S. branded sales team if Precedex generics launch

The launch of a generic of a key product in the U.S. always makes a sales organization uneasy because it inevitably means layoffs. But the last thing any sales team wants to hear is that its boss will have to lay off pretty much everyone if a generic comes to market. Yet that is what Hospira told a court is in store if it doesn't block copies of its sedative Precedex.

Depomed scores a win in its epic struggle to fend off Gralise copycats

On Tuesday, Depomed announced that it won its patent lawsuit against Actavis, which wanted to market a generic version of Depomed's shingles pain drug Gralise. Depomed's shares surged more than 13% in after-hours trading to $14.94.

Celgene cost-sharing deal sways NICE to greenlight new Revlimid use

Celgene used a tried-and-true technique to persuade cost-effectiveness watchdogs to change their minds on Revlimid. The U.S.-based drugmaker capped its cost.

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.