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.
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.
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.
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, 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.
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.
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.
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.
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.
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.