Celgene Corp.'s Istodax (romidepsin) got an accelerated nod, as expected, in peripheral T-cell lymphoma (PTCL) patients who have received at least one prior therapy, pitting it against Allos Therapeutics Inc.'s Folotyn (pralatrexate), a drug that suffered slower-than-expected sales despite being the first approved for PTCL.
Three years after restrictive labeling and labor-intensive postmarketing requirements crushed hopes for a potential blockbuster, GlaxoSmithKline plc handed back the last of its stake in constipation drug Entereg (alvimopan) to Adolor Corp., but analysts see the move as a positive for the Exton, Pa.-based biotech.
Only a few months after pulling in $25 million in equity funding, privately held Synageva BioPharma Corp. is gaining access to the public markets, as well as a nice chunk of cash, in a planned stock-for-stock merger with Trimeris Inc.
Ambit Biosciences Inc.'s venture syndicate stepped up for a $30 million Series D-2 round to help support the ongoing Phase II pivotal trial of acute myeloid leukemia (AML) drug AC220 and allow the San Diego-based biotech to avoid the less-than-friendly initial public offering (IPO) market.
Intercell AG's prophylactic vaccine against Staphylococcus aureus infections is out of the picture, two months after a Phase II/III study was halted for futility, with the news sending shares of the Austrian biotech falling 22 percent.
On the heels of its deal to apply its delivery technology to ViroPharma Inc.'s hereditary angioedema (HAE) drug, Halozyme Therapeutics Inc. inked another collaboration, this one with stealth biotech Intrexon Corp. valued at a potential $63 million.
The work at Epiomed Therapeutics Inc. dates back to NASA's efforts back in the 1980s to reduce motion sickness on the space shuttle, but the semivirtual biotech start-up has tweaked those early discoveries and set its sights on the multi-billion-dollar nausea and vomiting market.
Back in 2008, the FDA hit developers of diabetes drugs with new guidance requiring large and costly cardiovascular outcomes study, putting several late-stage programs in limbo. Now obesity drugmakers could find themselves facing the same fate.
Despite hailing two six-month pivotal studies' successes for Relovair in chronic obstructive pulmonary disease (COPD), South San Francisco-based Theravance Inc. saw its shares dinged by nearly a dollar Thursday as investors focused on the one endpoint that fell short of statistical significance.
After a three-day weekend to digest the news of Optimer Pharmaceuticals Inc.'s approval for macrolide antibiotic Dificid (fidaxomicin), investors jumped on the San Diego-based firm's stock (NASDAQ:OPTR) Tuesday, which, trading at seven times its average volume, gained $1.53, or 11.8 percent, to close at $14.51.
