Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: FDA clears first smartphone-based device to detect atrial fibrillation

AliveCor announced Aug. 21 that it has received FDA clearance for an algorithm to detect atrial fibrillation, and next month it plans to incorporate the new ability into its AliveECG app for monitoring the heart.

Cubist nears another big antibiotic approval as M&A rumors simmer

Lexington, MA's Cubist Pharmaceuticals is inching toward its second drug approval of the year, hoping to win European and U.S. clearance for a new anti-infective as analysts wonder whether the company is in line for a Big Pharma takeout.

DEA tightens opioid dispensing rules amid controversy over abuse

On Thursday, the Drug Enforcement Agency (DEA) announced that combination drugs containing hydrocodone will now be classified as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.

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. Patent and Trademark Office for an application granting the company new claims to RNA interference 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.