Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further

The FDA panel convened to discuss the risk of upstaging uterine sarcoma cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids recommended upgrading the labeling of power morcellators and ensuring that patients are made aware of the risk prior to surgery, among other measures.

EMA approves 39 drugs in H1, down from 44 last year

The European Medicines Agency approved 39 new drugs in the first half of the year, PharmaTimes reports.

Day One: Inside the FDA power morcellator panel

Panelists were concerned about the lack of data on the prevalence of uterine sarcoma among women undergoing hysterectomy or myomectomy surgeries during the first day of the FDA panel on the risks of upstaging uterine cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids.

Boston Scientific's Guidant faces more legal pushback in J&J lawsuit

Boston Scientific's Guidant subsidiary faces more legal pushback in its ongoing breach-of-contract lawsuit against Johnson & Johnson, as a federal judge denied the company's request to toss out the case.