Ophthotech Corp.'s potential $1 billion-plus, ex-U.S. deal with Novartis AG for Fovista, the antiplatelet-derived growth factor (PDGF) agent capable of enhancing the efficacy of anti-VEGF therapies in wet age-related macular degeneration (AMD), added juice to a growing $5 billion market – one about to take the next step into co-formulation. Read More
Coming as little surprise after an FDA advisory panel backed Entyvio (vedolizumab) for treatment of severe ulcerative colitis and moderate to severe Crohn's disease, Takeda Pharmaceutical Co. Ltd.'s drug gained approval on its May 20 PDUFA date, becoming the first integrin inhibitor to hit the market since Biogen Idec Inc.'s Tysabri (natalizumab). Read More
Shares in Genmab A/S opened Tuesday morning down 11 percent on overnight news that its anti-CD20 antibody Arzerra (ofatumumab) failed to demonstrate a progression-free survival (PFS) benefit over Rituxan (rituximab) in a phase III head-to-head study in patients with diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma (NHL). Read More
Adequate FDA resources and a greater commitment at the agency to consider expedited approval paths early in drug development would go a long way in advancing cures for rare diseases and other medical conditions, a House subcommittee was told Tuesday. Read More
Aadi LLC, a small new biotech company led by Abraxane (nab-paclitaxel) co-inventor Neil Desai, is in-licensing a once-shelved nanoparticle therapy from Celgene Corp. to develop it for oncology and cardiovascular indications. Celgene acquired the drug, ABI-009, in its 2010 acquisition of Abraxis Bioscience Inc. and retains an option to reacquire it in the new deal. Read More
Though biotechs Ardelyx Inc. and Kite Pharma Inc. have virtually nothing in common except headquarters in California, both filed for initial public offerings (IPOs) Monday, hoping to keep that wobbly window open. Read More
SHANGHAI – Neostem Inc. signed an exclusive license agreement with Cellular Biomedicine Group, of Shanghai, for its patient-specific immunotherapy (DC-TC) to treat late-stage hepatocellular carcinoma (HCC) in China, home to more than 45 percent of the world's HCC patients. Read More
Genprex Inc., of Austin, Texas, said it enrolled the first patient in a phase II trial to test lead candidate Oncoprex in combination with Tarceva (erlotinib, Roche AG and Astellas Pharma Inc.) in late-stage lung cancer patients. Read More
Glaxosmithkline plc, of London, presented data at the American Thoracic Society meeting in San Diego, showing that the addition of umeclidinium (UMEC) at either dose to inhaled corticosteroid and long-acting beta2 agonist combination fluticasone proprionate and salmeterol (FSC) resulted in a statistically significant improvement in lung function when compared with placebo plus FSC in patients with chronic obstructive pulmonary disease over 12 weeks. Read More
The SEC charged two California-based doctors this week with insider trading, alleging that they used their knowledge as investigators in a prostate cancer trial sponsored by Gtx Inc. to sell Gtx stock prior to the public announcement that the FDA had halted the study due to safety concerns. Read More
