The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted 14-4 Thursday in support of the use of TB Alliance's pretomanid as part of a combination regimen to treat the most resistant cases of tuberculosis (TB). Regimen was the key word. "I'm voting for a regimen, not a single drug," said Matthew Goetz, a professor at the David Geffen School of Medicine at the University of California-Los Angeles and chief of the infectious diseases division at the Veterans Affairs Greater Los Angeles Healthcare System. Read More
LONDON – The number of confirmed cases in the Ebola epidemic in the Democratic Republic of Congo (DRC) has reached 2,025, amid signs that control measures that have been effective in outbreaks elsewhere are unequal to the complex circumstances in the war-torn country. Read More
Axovant Sciences Ltd. has terminated its $187.5 million license and collaboration agreement with Benitec Biopharma Ltd., a Sydney-based gene therapy company, regarding AXO-AAV-OPMD (formerly BB-301) for treating oculopharyngeal muscular dystrophy (OPMD). Read More
HONG KONG – Aiming to expand its market in greater China, Cstone Pharmaceuticals Co. Ltd. submitted a new drug application (NDA) for Tibsovo (ivosidenib) to the Taiwan Food and Drug Administration (TFDA), seeking approval of the first drug to treat adults with relapsed or refractory (r/r) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Read More
PHILADELPHIA - While amounts raised through seed and series A venture capital rounds in 2018 have towered above previous years, indicating a growing interest in investing early, the money does not address a researcher's need to fund science at an even earlier stage, sometimes at the very beginnings of an idea. Read More
PHILADELPHIA – With a major gap remaining between the demographics of people enrolled in clinical trials and those most likely to use the drugs the FDA approves, the agency is pushing forward with new steps to tackle the complex problem, issuing a draft guidance on enhancing trial population diversity on Thursday. If successful, the move could complement the efforts of industry and its partners as they pursue everything from community outreach to simple logistical supports. Read More
PHILADELPHIA – This year's Australian delegation saw the most impressive participation to date at the Biotechnology Innovation Organization's (BIO) 2019 conference, with more than 150 Australian companies participating as well as numerous government representatives. Read More
PHILADELPHIA – Compared to oncology, chronic diseases such as cardiovascular disease, diabetes and dementia represent much more substantial costs to the overall U.S. health care system, yet investment and R&D innovation in those areas has been on a steady decline over the past decade or so, according to research compiled by the Biotechnology Innovation Organization (BIO). Read More
Insys Therapeutics Inc., of Phoenix, entered a $225 million settlement to resolve separate criminal and civil investigations into its marketing of Subsys, a sublingual fentanyl spray approved by the FDA in 2012 for the treatment of breakthrough pain in cancer patients. Read More
Bioventus LLC, of Durham, N.C., entered a collaboration agreement with tissue bank MTF biologics to co-develop a next-generation placental tissue product for treating musculoskeletal conditions, with an initial focus on knee osteoarthritis. Terms of the deal were not disclosed. Read More
Third Rock Ventures LLC, of Boston, said it closed an oversubscribed Third Rock Ventures V LP fund, raising $770 million. This new fund will support its ongoing strategy of discovering, launching and building innovative life sciences companies. Read More
