The next generation of hepatitis C virus (HCV) therapies moved a step closer to the corner drugstore with the initiation of Pharmasset Inc.'s pivotal Phase III studies of the HCV nucleotide analogue PSI-7977. The program will evaluate a 12-week, all-oral, interferon-free regimen of PSI-7977 and ribavirin in three groups of patients with HCV, independent of viral genotype or their ability to take interferon therapy.The Princeton, N.J.-based company expects to submit data from the three Phase III trials in the second half of 2013, both in the U.S.
Privately held AgonOx LLC, which could afford to be picky with its hot T-cell technology, selected MedImmune LLC, a unit of AstraZeneca plc, over more than two dozen other potential suitors for an exclusive global agreement to develop agonists and other immune system activators for cancer therapy using AgonOx's OX40 platform.OX40 is a protein transiently expressed on the surface of effector T-cells, but only after activating the T-cells with immune-stimulating antigens, including tumor antigens.
Salix Pharmaceuticals Ltd. delivered bad news to investors Thursday morning. Based on a phone call with the FDA Wednesday evening, the Raleigh, N.C.-based company now expects to receive a complete response letter (CRL) on its supplemental new drug application (sNDA) for Xifaxan (rifaximin) 550-mg tablets for the treatment of non-constipation irritable bowel syndrome (non-CIBS) and IBS-related bloating.
Fresh off a big score at the Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis conference in Amsterdam, the Netherlands, for its oral multiple sclerosis immune modulator BG-12, Biogen Idec has inked a multi-million-dollar deal with privately held Portola Pharmaceuticals Inc. (See BioWorld Today, Oct.
Ahead of schedule, on Wednesday Onyx Pharmaceuticals Inc. and partner Bayer HealthCare Pharmaceuticals reported positive Phase III data for the VEGF-multikinase inhibitor regorafenib (BAY 73-4506) in patients with metastatic colorectal cancer (mCRC) whose disease has progressed after standard treatment.While keeping details under wraps, the companies said the trial met its primary endpoint of statistically significant improvement in overall survival.
Gilead Sciences Inc. and privately held GlobeImmune Inc. turned up the heat on an already sizzling hepatitis space by inking an exclusive worldwide license and collaboration to develop therapeutic vaccines that use Gilead's Viread (tenofovir disoproxil fumarate) and other oral therapies to treat chronic hepatitis B virus (HBV).
Cubist Pharmaceuticals Inc., which focuses on the development of drugs to combat conditions prevalent in the hospital setting, will expand its product pipeline with the acquisition of Adolor Corp. in a deal potentially valued at $415 million.
Canadian biotech Sunshine Biopharma Inc. is seeking to bring a ray of light to women with multidrug-resistant breast cancer by arresting the rapid development and spread of their disease.
Biotech start-up Arteaus Therapeutics LLC raised $18 million in a Series A financing from Atlas Venture, of Cambridge, Mass., and OrbiMed Advisors, of New York, to advance a migraine headache antibody technology licensed from Eli Lilly and Co.
Despite its moniker, privately held Stealth Peptides Inc. is poised to make a name for itself in the development of mitochondrial-targeted therapies, potentially addressing cardiovascular, renal, ophthalmologic, neurologic and metabolic indications.
