The FDA posted briefing documents related to the Nov. 6 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, and Wall Street’s opinion turned out decidedly mixed regarding the odds for aducanumab, the anti-amyloid beta monoclonal antibody for Alzheimer’s disease from Cambridge, Mass.-based Biogen Inc. and Eisai Co. Ltd., of Tokyo. Read More
An earlier-than-intended release of abstracts for the American Society of Hematology annual meeting spilled multiple market-moving updates Nov. 4, though with no apparent shocks so far. Shares of Allogene Therapeutics Inc. sunk 8% on Nov. 4 over some metered disappointment around initial data for ALLO-715, a potential medicine for relapsed/refractory (r/r) multiple myeloma. By contrast, shares of Global Blood Therapeutics Inc. climbed nearly 15%, buoyed by new data supporting the long-term use of its sickle cell disease therapy, Oxbryta (voxelotor). Read More
HONG KONG – Pangyo, South Korea-based SK Biopharmaceuticals Co. Ltd. has agreed to collaborate with New York-based Lifesci Venture Partners to invest in private health care companies developing novel therapies and innovative technologies. Read More
One of the reasons that pancreatic cancer remains such a stubbornly dismal disease is that it is extremely desmoplastic. In other words, most of a pancreatic tumor is not made up of tumor cells, but of stroma. Stroma, in turn, is a double-edged sword for the tumor cells. Its connective tissue component impedes blood flow, which is part of what makes pancreatic cancer so drug-resistant. But the lack of blood also means a lack of oxygen and nutrients, so pancreatic tumors must find alternate ways to feed themselves. That’s where nerves come in. In the Nov. 2, 2020, online issue of Cell, researchers published new insights into how innervation feeds tumors, and how to stop them from doing so. Read More
LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation. Read More
It didn’t take long for a U.S. district judge to grant Gilead Sciences Inc.’s request for a temporary restraining order to stop two interconnected health care networks in Florida from defrauding the company’s Advancing Access Medication Assistance Program that provides free HIV pre-exposure prophylaxis drugs to eligible, uninsured people. Read More
HONG KONG – Humanigen Inc. has executed its first licensing agreement in the Asia-Pacific region, in a deal worth up to $20 million that gives Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. the development and commercialization rights to lenzilumab for COVID-19 in South Korea and the Philippines. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: PhRMA: Broader response to trade barriers needed; Russia setting up drug purchasing center. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzinova, Biomx, Calithera, Cassava, Ionis, Nanology, Nektar, Pfizer, Soleno, Vtv. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axsome, Bristol, Equillium, Generex, Ionis, Jubilant, Myokardia, Novan, Novavax, Ocular, Pfizer, Prothena, Salliant, Sofie. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lianbio, Logicbio, Pharmacyte, XNK. Read More
