Back in 2008, biotech companies working on cancer vaccines were not exactly shouting it from the rooftops. In fact, most companies working in the space quietly began branding their drug candidates “immunotherapies” when they met with investors in an attempt to avoid connection with the spate of disappointing headlines such as the ones that ran in BioWorld Today – “Cell Genesys Crushed on Latest GVAX Failure,” “Favrille Sinks on Phase III Failure of Lead Cancer Drug” and “Genitope Dropping MyVax Work, Focusing Instead on Antibodies.” Then Dendreon Corp.’s Provenge (sipuleucel-T) hit its Phase III survival endpoints and won FDA approval...
San Diego-based Panmira Pharmaceuticals LLC is not the traditional biotech start-up. Founded this month to develop assets spun out ahead of Bristol-Myers Squibb Co.'s July acquisition of Amira Pharmaceuticals Inc., the new company really could be labeled Amira Part Two.
Figuring out how to get chemotherapy directly into tumor cells while sparing healthy cells has long been one focus of cancer drug development. The trick is developing a targeted drug delivery vehicle that's actually capable of penetrating cells.
Gilead Sciences Inc. dropped dosing of its non-nucleoside polymerase inhibitor GS 9190 in combination with interferon and ribavirin in the wake of two adverse events in separate studies testing four-drug regimens in patients with hepatitis C virus (HCV), but the news is not expected to affect the firm's all-oral, interferon-free HCV program.
PTC Therapeutics Inc.'s Duchenne's muscular dystrophy (DMD) program looks to be the first casualty of Genzyme's Corp.'s acquisition by Sanofi SA, with the Cambridge, Mass.-based biotech handing back ex-North American rights to ataluren.
NuPathe Inc.'s Zelrix, a version of sumatriptan delivered via a patch for migraine sufferers unable to take the oral therapy, won't hit the market next year as planned after the FDA issued a complete response letter (CRL) requesting additional information, news that sent shares of the Conshohocken, Pa.-based firm plunging 34.6 percent.
Privately held Zymeworks Inc. emerged from stealth mode this week, with its first major commercialization deal matching up its bispecific antibody technology with drug development at Merck & Co. Inc. in the areas of oncology and autoimmune diseases.
Only two months after Shire plc shelled out $750 million in cash for Advanced BioHealing Inc. – a move hailed as a rare win for investors in the regenerative medicine space – the big pharma reported disappointing data from a pivotal trial aimed at expanding the use of ABH's lead product Dermagraft.
Investors of United Therapeutics Corp. experienced a bit of déjà vu Wednesday as shares took a tumble on disappointing data from a Phase III study testing oral treprostinil on top of background therapy in patients with pulmonary arterial hypertension (PAH).
Mountain View, Calif.-based Vivus Inc. priced a registered direct offering of 6.9 million shares at $6.65 each for gross proceeds of $45.8 million to boost its balance sheet and support ongoing work with obesity drug Qnexa (phentermine/topiramate), including the resubmission of a new drug application (NDA) expected next quarter.
