Topic:

Regulatory

Latest Headlines

Latest Headlines

Boston Scientific wins expanded European approval for Lotus transcatheter valve system

Boston Scientific won expanded European approval for its Lotus transcatheter valve system, adding to the company's current aortic valve offerings and bolstering its presence in overseas markets. 

Fifth Circuit backs shield against branded pharma's liability for generic harms

The court fight over Pfizer's stomach drug Reglan (metoclopramide) has yielded another ruling in Big Pharma's favor. Once again, a U.S. court has ruled that branded drugmakers can't be sued for damages allegedly caused by generic versions of their drugs.

Titan Spine wins 510(k) for spinal fusion implant

Wisconsin's Titan Spine announced today that it received 510(k) clearance from the FDA for its Endoskeleton TL System implant for spinal fusion.

FDA cites Italian API maker for deleting all analytics

FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.

Roche's Avastin up for another lift with fast-track cervical cancer review

Roche's cancer blockbuster Avastin has yet another shot at boosting sales. The FDA put Avastin up for priority review in cervical cancer, with a decision date of Oct. 24.

Roche's Avastin steps on FDA fast track for new cervical cancer use

When it comes to expanding Avastin into new cancer territories, Roche has a win-some, lose-some record. Now, Roche is closer to adding cervical cancer to its arsenal of indications in the U.S.

Boston Scientific wins CE mark for next-generation drug-coated balloon catheter

Boston Scientific won a CE mark for its next-generation drug-coated balloon catheter for peripheral artery disease, expanding its presence in the endovascular market and continuing its push to reinvigorate sales.

PhRMA, BIO, GPhA ask court to trash California drug disposal law

Pharmaceutical companies, which have been fighting a county drug disposal law in the California Bay area for nearly two years, say they exist to develop and produce drugs, not to be waste disposal companies. But that is what the law in Alameda County would require them to become, they told a federal appeals court.

Riled by $84,000 Sovaldi, Senate panel digs into Gilead's Pharmasset buy

Add a new set of pricing foes for Gilead Sciences). A U.S. Senate committee has joined the forces arrayed against the company's breakthrough hepatitis C drug Sovaldi and its $84,000 price tag.

FDA warns Gilead over 'misleading' paid search link

The drug is approved for treating--not preventing--hepatitis B, prompting FDA to call the advert misleading.