Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA allows Covidien to restart manufacturing of two recalled devices

The FDA approved Covidien's fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.

IRS claims device tax collection falls short

The Internal Revenue Service is having just as much trouble deciphering the Affordable Care Act as the general public. The Act levies a 2.3% tax on medical device companies, but the IRS reports that it believes it is only collecting 76% of tax owed.

GlaxoSmithKline grabs FDA approval for its latest asthma treatment

GlaxoSmithKline's banner respiratory division picked up another FDA approval, securing the agency's blessing for an inhaled asthma treatment as it expands its stable of drugs for airway disorders.

Celgene's cost-sharing offer persuades NICE to about-face on Revlimid

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.

Alnylam receives more good news on the IP front

Alnylam Pharmaceuticals received a Notice of Allowance from the U.S. Patents and Trademarks Office for an application granting the company new claims to RNA interference (RNAi) medicines.

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.