The promise of RNAi – the idea that specific genes can be pinpointed and silenced to treat disease – has loomed large on biopharma's radar for the past decade, even netting a 2006 Nobel to RNAi discoverers Craig Mello and Andrew Fire.
The long-awaited approval of Arena Pharmaceuticals Inc.'s Belviq (lorcaserin) looks to bode well for its contemporaries – Vivus Inc.'s Qnexa (phentermine/topiramate), which has a PDUFA date of July 17, and Orexigen Therapeutics Inc.'s Contrave (naltrexone/bupropion), which is in an FDA-required cardiovascular outcomes study to address a complete response letter – but it could also offer some assurances for other companies with earlier-stage obesity candidates coming down the pike.
Galera Therapeutics Inc., a 2009 start-up based on the approach of treating disease by targeting superoxide, came out of stealth mode in December with a new CEO and a Series A financing of $11 million.
It may have taken more than two decades, but NPS Pharmaceuticals Inc. is set to launch its first commercial product in the first quarter, following Friday's FDA approval of Gattex (teduglutide [rDNA origin]) as a long-term treatment for short bowel syndrome (SBS).
Now that 2012 is drawing to a close, it’s once again time to take a look back at a year that saw some big hits and misses for the biotech industry – and there were plenty of both. The hits saw some big drug approvals – some of those well in advance of PDUFA dates, which, hopefully, is a good sign that the FDA is willing to accelerate approvals in areas of high unmet need – and major clinical advances in areas such as hepatitis C, while the misses included disappointing data and some stark realities facing big pharma firms....
Ariad Pharmaceuticals Inc. got an unexpected holiday gift from the FDA, with the agency granting approval to its much-lauded pan BCR-ABL inhibitor, ponatinib, more than three months ahead of the drug's March 27, 2013, PDUFA date, and only two months after the Cambridge, Mass.-based firm completed a rolling new drug submission.
As a handful of global pharma firms vie for bigger portions of the increasingly popular dermatology market, a new entrant entered the space earlier this year: Aclaris Therapeutics Inc., which launched with a $21 million Series A round to advance its lead topical dermatology program into clinical testing.
Only days after highlighting abstracts for its upcoming presentations at the American Society of Hematology (ASH) meeting in Atlanta and CEO Ron Squarer's assertion that his firm was "evolving into a late-stage development company" with five programs moving toward pivotal decisions in 2013, Array BioPharma Inc. is doubling its cash position with a $65.7 million public offering.
Disappointing clinical data clobbered shares of two biotech firms Thursday: BioCryst Pharmaceuticals Inc. fell 40.4 percent on news that a Phase III trial of influenza candidate peramivir would be halted for futility, while Catalyst Pharmaceutical Partners lost nearly two-thirds of its value after reporting a Phase IIb miss for cocaine-dependence candidate CPP-109.
