Trying to translate discovery research and early clinical data into phase III success has proved the bane for drug developers working in Alzheimer's disease. But executives at Agenebio Inc., which is gearing up to start a phase III study in the second half of this year with lead product AGB101, think their approach will be up to the task.
CTI Biopharma Corp.'s pacritinib hit the primary endpoint in the first phase III study evaluating the next-generation JAK2/FLT3 multikinase inhibitor in myelofibrosis patients, with top-line data also showing benefit in a subset currently not helped by marketed JAK2 inhibitor Jakafi (ruxolitinib), findings that could provide crucial differentiation in the marketplace.
The latest foray in the oft-thorny RNAi patent landscape sees Arrowhead Research Corp. nabbing the entire RNAi portfolio of Novartis AG, picking up rights to a host of intellectual property (IP) and assets, including an existing license agreement with RNAi powerhouse Alnylam Pharmaceuticals Inc., a pipeline of three preclinical candidates and a patent estate the Pasadena, Calif.-based biotech said falls safely outside the scope of competitors' IP.
In the biopharma space, finding potential new uses for shelved drugs has become a business model unto itself, with proponents touting successes such as AZT – a drug that bombed in cancer trials only to return two decades later as the first approved therapy for HIV – and the National Institutes of Health even endorsing the strategy, setting up the National Center for Advancing Translational Sciences as a matchmaker to hook up researchers with failed compounds in 2012.
Rather than seeking a new partner after a worldwide licensing deal with Roche AG quietly terminated last year, privately held Chiasma Inc. decided to take its new drug application (NDA)-ready oral octreotide to market in the U.S. on its own.
A competitive partnering process for a preclinical-stage asset gave way to broader negotiations that brought together former Amgen Inc. colleagues and resulted in a deal that could accelerate the growth of low-flying biotech NGM Biopharmaceuticals Inc. beyond its early work in cardio-metabolic diseases.
NEW YORK – The Biotechnology Industry Organization's (BIO) first-ever venture capital study, which analyzed U.S. venture investments during a 10-year period – 2004 to 2013 – turned up several positive trends such as the increasing shift toward biologics and novel drug development, but there was one set of data that gave investors pause. (See BioWorld Today, Feb. 10, 2015.)
NEW YORK – The 17th annual BIO CEO & Investor Conference wrapped up, with the Biotechnology Industry Organization reporting more than 2,220 partnering meetings over the two-day event and a session schedule that hit all the big topics as industry experts offered up insight and lessons learned.
NEW YORK – "It's probably not an exaggeration to say there's a lot of hype" surrounding the microbiome space, noted Mark Breidenbach, of H.C. Wainwright & Co., who moderated a panel on the subject at the annual BIO CEO & Investor Conference.
NEW YORK – If the current trend in venture investment is a harbinger of what's to come, then it's good news for firms developing biologics, according to a report released today by the Biotechnology Industry Organization (BIO) that highlighted positive – and some negative – funding trends that have emerged in the last decade.
