Hopes remain for Unity Biotechnology Inc.’s UBX-1325 in diabetic macular edema (DME) following a phase II miss in wet age-related macular degeneration (AMD), where data from part A of the study called Envision fell short of the non-inferiority threshold when compared to Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) through 24 weeks. Read More
A lot of eyes and ears were tuned to the U.S. Supreme Court’s March 27 argument in Amgen Inc. v. Sanofi SA with its focus on how much enablement is necessary in broad genus patent claims. Read More
Preparing for next month’s launch of the first U.S. FDA-approved therapy for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare disease only identified 10 years ago, Pharming Group NV disclosed pricing for the newly branded Joenja (leniolisib) of $750 per tablet, or $547,500 per year. Read More
Ionis Pharmaceuticals Inc. and Astrazeneca plc’s candidate for hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), eplontersen, has continued to improve disease progression out to 66 weeks, according to Ionis. Read More
Jounce Therapeutics Inc. is leaving Redx Pharma plc at the altar after deciding instead to merge with Concentra Biosciences LLC. In late February, Jounce had said it planned to merge with Redx in an all-share transaction that would have created a $425 million combined entity. Read More
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd. RAY-1216 is a peptidomimetic inhibitor of SARS-CoV-2 main protease (Mpro), which is also known as a 3C-like protease (3CLpro). Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biochestra, Codiak, Crispr, Everest, Firefly Neuro, Gilead, Immunomedics, Merck, Pfizer, Stalicla, Vertex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Henlius, Incyte, Janssen, PTC. Read More
