Latest Headlines

Latest Headlines

FDA OKs expanded label for InSightec's noninvasive ultrasound fibroid device

The FDA has signed off on Israeli devicemaker InSightec's ultrasound technology to treat women with uterine fibroids who want to conceive, a win for the company as it pushes for new indications of its product and reels in funding to spur R&D.

FTC warns consumers against buying unapproved weight-loss devices

Alongside the FDA, the Federal Trade Commission oversees the marketing and promotion of medical devices. FTC Consumer Education Specialist Aditi Jhaveri took to the agency's blog to warn consumers against purchasing unregulated devices that promote "do-it-yourself" projects, such as weight loss.

Cell Therapy mulls IPO as regenerative medicine boards EMA fast track

The European Medicines Agency has put Cell Therapy's Heartcel on its conditional approval pathway, raising the possibility that the allogeneic stem cell therapy could come to market in 2017. And with the drug now nearing the market, Cell Therapy has begun to sound out investors about an IPO.

Bristol takes aim at three more hep C niches with Daklinza

In the face of hefty hep C competition from Gilead and AbbVie, can Daklinza profit from a set of niche uses?

Merck KGaA and Pfizer get their fifth-place immunotherapy on the FDA fast track

Merck KGaA and Pfizer, playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.

OptiNose raises up to $30M to get drug-device combo through FDA

Specialty pharma OptiNose hopes to use up to $30 million in new financing to get its OPN-375 in combination with its novel breath-powered device through the FDA. But the agency already demonstrated some skepticism around the device last year--it issued a complete response letter to OptiNose partner Avanir because of device errors and required further testing.

The FDA is lukewarm on those hyper-valuable vouchers for fast drug reviews

Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for neglected diseases. But the agency seems less than enthusiastic about honoring its end of the bargain, with one top official expressing concerns about how the voucher program might harm the FDA's core mission.

Advaxis offers a tardy defense after FDA puts cancer vaccine on hold

Two weeks after reporting that its cancer vaccine spurred a positive response among a group of cervical cancer patients in a small clinical trial, Advaxis waited until after the market closed today to reveal that the FDA has placed the same cancer vaccine--axalimogene filolisbac (ADXS-HPV)--on a clinical hold, slamming the brakes on four studies.

FDA slaps most serious label on MicroPort hip implant device recall

China's MicroPort earned the FDA's most serious designation over a recall of devices used in hip joint replacement surgery after reports surfaced that showed the products could be endangering patients' lives.

Novocure nabs first-line FDA approval for glioblastoma, turns to reimbursement and other solid tumors

Europe's Novocure has won an expanded indication for a 2011 FDA approval of its Optune to treat newly diagnosed glioblastoma in combination with temozolomide, a standard chemotherapy. The company has been on a roll of late, disclosing a CE mark for its second-generation version of Optune on Oct. 5 and pricing a $165 million IPO on Oct. 2.