There’s a growing renewal of interest in CDK9 as a therapeutic target, including by two companies adding to the momentum with a $150 million deal. Sellas Life Sciences Group and Genfleet Therapeutics Inc. entered an exclusive license agreement granting Sellas rights to develop and commercialize the small molecule CDK9 inhibitor GFH-009 outside mainland China, Hong Kong, Macau and Taiwan. Read More
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application. Read More
Shares in Pharming Group NV were up after the company announced detailed data from its phase II/III trial of leniolisib for the rare disease activated phosphoinositide 3-kinase delta (PI3K-delta) syndrome (APDS). Read More
Back in 2015, a black box warning from the U.S. FDA about the cardiovascular risks of testosterone therapy products caused a major upheaval in the market. Read More
There is a project management joke that the first 90% of a project takes 90% of the time, whereas the last 10% of the project takes the other 90% of the time. Read More
Biosion Inc. has out-licensed ex-China rights for its anti-Siglec-15 monoclonal antibody BSI-060T and additional preclinical assets with the same target to Pyxis Oncology Inc. for $10 million up front and potential milestone payments of up to $222.5 million, plus single to low double-digit royalties on commercial sales. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abeona, Alcresta, Amarin, Asceneuron, Catalyst, Fauna, GHIT, Quantum, Silverback, SK, Stealth, Surface, T2, Tevard. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akston, Amylyx, Autolus, Cytodyn, Design, Everest Medicines, Gilead Sciences, Glaxosmithkline, JW, Mission, Nordic, Novartis, Novavax, Outlook, Sorrento, Vir, Xortx. Read More
