Concerns voiced during January’s U.S. FDA advisory committee meeting failed to deter Cidara Therapeutics Inc. from winning approval by the agency March 22 for once-weekly Rezzayo (rezafungin for injection) to treat a pair of indications – candidemia as well as invasive candidiasis (IC) – in adults with limited or no alternatives. Read More
Incyte Corp.’s retifanlimab-dlwr received its first regulatory nod on March 22, with the U.S. FDA granting accelerated approval for the PD-1 inhibitor to treat adults with a rare form of skin cancer, advanced Merkel cell carcinoma. Read More
Tofersen’s development is progressing in fits and starts. That was evident at the U.S. FDA’s March 22 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, which unanimously agreed Biogen Inc.’s failed phase III study predicted a clinical benefit in treating amyotophic lateral sclerosis (ALS) that includes the rare superoxide dismutase 1 component. Read More
Biohaven Ltd. has acquired global rights, excluding China, from Highlightll Pharmaceutical Co. Ltd. to develop and commercialize a dual inhibitor of tyrosine kinase 2 (TYK2) and JAK1, BHV-8000 (TLL-041), for the treatment of brain disorders in a deal worth up to $970 million. Read More
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease. Read More
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China. Read More
Mbiomics GmbH raised €13 million (US$14.2 million) in a first close of a series A round that will enable it to pivot from being a microbiome analytics firm to becoming a therapeutics developer. Read More
Just days after Karuna Therapeutics Inc. reported positive data from a third registrational trial of Karxt (xanomeline plus trospium) in schizophrenia, Puretech Health plc sold a portion of its royalty in Karxt in a potential $500 million agreement with Royalty Pharma. Puretech was a founder of Karuna and co-inventor of Karxt, an oral M1/M4-preferring muscarinic agonist. Read More
New hires and promotions in the biopharma industry, including: Imcheck, Janone, Jasper, Monte Rosa, Morphimmune, Neogap, Outpace, Regencor, Sosei, Vividion. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arch, Asahi Kasei, Basilea, Bayer, Everest, Generation Bio, Gilead, Macomics, Macrogenics, Moderna, Ono, Onconova, Orion, Pangea, Pionyr. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Athersys, Avadel, FSD, Iecure, Marinus, Mesoblast, Regeneron, Sandoz. Read More
