The accelerated clearance won by Johnson & Johnson (J&J) from the U.S. FDA for Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma (r/r MM) in adults brings to the market the bispecific antibody that takes aim at G protein-coupled receptor class C group 5 member D, a target of interest to other developers as well. Read More
A complete response letter (CRL) from the U.S. FDA for GC-4419 (avasopasem) is causing Galera Therapeutics Inc. to dramatically change course to survive, with the company laying off about 70% of its workforce. That layoff, which will reach across several company departments, is designed to extend the cash runway into the second quarter of 2024. The adjustment comes after Galera expanded its commercial leadership in May to prep for a potential launch of avasopasem before the end of 2023. Read More
Building out its metabolic franchise, Novo Nordisk A/S is buying privately held Montreal-based Inversago Pharma Inc. for up to $1.075 billion, gaining lead asset INV-202, an oral cannabinoid 1 (CB1) inverse agonist. The candidate has demonstrated weight loss potential in a phase Ib trial and is currently in a phase II for diabetic kidney disease. Novo Nordisk’s interest in INV-202 is to explore its potential for obesity and obesity-related complications. Read More
Modalis Therapeutics Corp. – previously Edigene Corp. – has regained full rights to two gene therapy candidates for muscle disorders, MDL-201 and MDL-202, that were co-developed with Astellas Pharmaceutical Inc. since 2019. Read More
With more than 70,000 people living with cystic fibrosis (CF) worldwide, according to the Cystic Fibrosis Foundation, the introduction of CF transmembrane conductance regulator (CFTR) modulator therapies has revolutionized treatment of the disease. However, these drugs are not effective for around 10% of CF patients, driving a significant unmet therapeutic need. One startup hoping to address this is Anoat Therapeutics. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10X Capital, Addimmune, AGT, Amyris, Arcutis, Clinigen, CNX, Corium, Hikma, Huadong, Inovio, Lotus, Nashville, Rakuten, Recce, Standigm, XNK. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Futura, Georgiamune, Lemonex, Precigen, Virios. Read More
