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.
FDA's May 28 approval of Natesto, the first nasally delivered testosterone gel for hypogonadism, came just in time for Canada's Trimel Pharmaceuticals, which had just $18 million left on hand at the beginning of the year.
AstraZeneca has won FDA approval for its new prescription strength fish oil therapy for artery-clogging fats, but don't look for it to help much in its nascent effort to convince investors that its bright prospects should make them steer clear of Pfizer's takeover pitch. This drug is headed into a crowded field that now includes a low-priced generic competitor.
After a quick march through the clinic, Novartis has won early FDA approval for the new "breakthrough" lung cancer drug ceritinib (or LDK378), which will now be launched as Zykadia.
The wave of new drug approvals that had been building at the FDA has broken. According to the official tally of new drug and biologics approvals at the agency, the biopharma industry registered only 27 OKs for new entities in 2013--a sharp plunge from 2012's high of 39 that once again raises big questions about the productivity and sustainability of the world's multibillion-dollar R&D business.
The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics (and Johnson & Johnson.