Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair

It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis and Roche. Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.

GVK accused of tampering with data in Indian clinical trials

Indian CRO GVK Biosciences is working to get back in the good graces of European regulators after inspectors found evidence that its employees doctored clinical trial results.

The FDA commits $16M to track prescription drug use

The FDA has set aside $16 million for tracking which drugs are used, in what combinations and for how long, Regulatory Focus reports.

Alimera and pSivida finally win FDA approval for thrice-rejected drug

After a series of painful rejections, partners Alimera Sciences and pSivida have finally convinced the FDA to approve the eye drug Iluvien, sending each company's shares roaring on some renewed optimism for the long-delayed treatment.

Credit Suisse: FDA 483 unlikely to lead to import alert for Sun

Details of the FDA Form 483 that has loomed over Sun Pharma for the past two weeks have become public. Credit Suisse reports FDA inspectors made 23 observations during a recent inspection of a plant that accounts for up to 25% of Sun's sales, but the regulator found no evidence of data integrity failings.  

Lew's tax rules prompt AbbVie to weigh financing for Shire deal

U.S. Treasury Secretary Jack Lew hasn't scared Big Pharma away from tax inversion deals altogether. But his new rules limiting the benefits of pharma's latest M&A strategy are having some tangible effects already.

EU panel backs slew of new drugs and uses, boosting Lilly, AZ, Novartis, Gilead and more

When Europe's drug approval gatekeepers meet, they often tick off recommendations for some key Big Pharma products. This week, the Committee for Medicinal Products for Human Use backed a whopping 15 new meds and 3 new indications.

Gilead nears EU approval for the next big thing in hep C

Gilead Sciences, already a trailblazer in hepatitis C treatment, is creeping up on its next milestone: approval for a combination therapy that promises to cure the majority of patients without the need for painful injections.

FDA's Mini-Sentinel set to graduate on October 1

The FDA's Mini-Sentinel has long since outgrown its "mini" moniker and is now ready to graduate from being a pilot project to being an integral part of the agency's drug-safety infrastructure. Many people welcome the program's progress, but doubts and dissenting voices remain.

BIO, PhRMA seek FDA reassurance over scope of Twitter guidance

The window for commenting on the FDA's draft guidance on pharma's use of Twitter and other social media slammed shut last week, leaving the agency with a stack of feedback to consider. Many of the respondents are unhappy with the draft, which was called unconstitutional and overbroad.