Amicus Therapeutics, fresh off reviving a once-failed drug, has reached an accord with U.S. regulators and is on track to submit its rare disease treatment for FDA approval before the end of this year.
Orthopedic specialist Wright Medical is up almost 10% to a $1.2 billion valuation in early trading on the news that its Augment Bone Graft has been granted a PMA approval. It's slated for use as an alternative to auto-graft for ankle or hind-foot fusion indications.
BioDelivery Sciences' Onsolis, a cancer pain treatment that makes use of the company's buccal delivery platform, picked up a new FDA approval for a reformulation of the treatment, which is expected to return to the U.S. market in 2016. BioDelivery earlier this year pulled out of a commercialization partnership with Sweden's Meda, which decided to focus more on respiration, and BioDelivery is currently looking for a new partner.
The marketer of the Lap-Band, the most successful medical device marketed in the U.S. to aid weight loss, has gained an FDA approval for what it hopes will lead the next wave of obesity devices--the Orbera Intragastric Balloon.
Whether looking at Phase III success, drug launches or product sales, biopharma is hitting its stride in R&D, according to new analysis from Thomson Reuters. And, as the industry evolves its approach to research and regulators speed up the review process, the latest upswing could be a sign of better days ahead for drug developers.
Otsuka and its partner Lundbeck snagged an FDA approval for Rexulti (brexpiprazole) to treat schizophrenia and as an add-on therapy for major depression, leaving the two companies prepping for an August launch into an increasingly crowded field.
St. Jude Medical got FDA approval to resume a U.S. trial of its transcatheter aortic valve system, a win for the company as it recovers from safety concerns tied to the device last year.
Actavis announced FDA approval of its drug delivering intrauterine device, Liletta, as a form of reversible contraception.
Medical device approvals continued at a steady clip in 2014 despite mounting pressure from lawmakers to roll out a more stringent review process.
On the heels of FDA's rejection of the AcelRx New Drug Application for sublingually delivered postoperative pain killer Zalviso, CEO Richard King expounded on the "optical system errors" of the opioid drug's handheld, preprogrammed delivery device during a July 28 conference call with investors.