The release by the U.S. CMS of the final national coverage determination (NCD) for Biogen Inc.’s Alzheimer disease (AD) drug, Aduhelm (aducanumab), lit speculation on the meaning for others in the space. CMS is “still being conservative,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “We’re in a new era. It’s unprecedented that Medicare doesn’t pay for a drug that received approval from the FDA,” even though it was not a full but an accelerated clearance. Read More
Elevated serum creatinine levels in some participants prompted Biocryst Pharmaceuticals Inc. to pause three clinical trials involving BCX-9930, an oral, small-molecule factor D inhibitor for treating rare diseases. Read More
Harbour Biomed Therapeutics Ltd. has out-licensed a preclinical bispecific antibody, HBM-7022, to Astrazeneca plc in a global licensing deal worth up to $350 million. Read More
Everest Medicines Ltd. has formed a partnership with China Resources Pharmaceutical Group (CR Pharma) to co-launch an independent company to focus on the development of messenger RNA (mRNA) vaccines. The new entity will take over rights Everest obtained through a collaboration with Providence Therapeutics Holdings Inc. They include the full technology platform and Everest’s mRNA manufacturing infrastructure. Read More
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III. Read More
After an eight-year academic collaboration with Glaxosmithkline plc, Kynos Therapeutics Ltd. has spun out of Edinburgh University with a £9 million (US$11.7 million) financing and a phase I-ready program. The company specializes in kynurenine 3-monooxygenase (KMO), a mitochondrial outer membrane protein that is a critical gatekeeper in the kynurenine pathway of tryptophan metabolism, and which regulates inflammation and immunity. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abionyx, Akston, Annexon, Aptinyx, Ardelyx, Erytech, Meji, Pathalys, Talaris, Tonix, Vyne. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akebia, Aosaikang, Aspect, Astrazeneca, Emergex, Everest, Genmab, Halozyme, J&J, Medisix, Melinta, Moderna, Propella, Twist, Vaccitech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Henlius, Ilias, Minerva, Regeneron, Sanofi, Triastek. Read More
