Biogen Idec Inc.'s fourth-quarter earnings missed estimates, but Wall Street barely noticed as revenue topped expectations, driven largely by steady growth in multiple sclerosis (MS) drugs Avonex (interferon beta-1a) and Tysabri (natalizumab), with investors already looking ahead to the much-anticipated launch of oral MS drug BG-12.
A month after the earlier-than-expected approval of Iclusig (ponatinib) in chronic myelogenous leukemia (CML), Ariad Pharmaceuticals Inc. is taking advantage of the current public markets to more than double its cash balance.
With antibiotic candidate tedizolid nearing the finish line, Trius Therapeutics Inc. is shoring up its balance sheet with a $29.9 million public offering, strengthening its position ahead of partnering discussions in Europe.
Three months after its shares were clobbered on disappointing survival data in non-small-cell lung cancer (NSCLC), ArQule Inc.'s stock sank again, after tivantinib, its MET inhibitor, missed primary and secondary endpoints in a Phase II trial in second-line colorectal cancer (CRC).
Despite a clinical setback in 2009, when two massive Phase III trials of cangrelor were halted for lack of apparent efficacy, the antiplatelet candidate is back on track, as The Medicines Co. reported positive results from a new Phase III study.
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....
