As Novo Nordisk A/S and Eli Lilly and Co. go head-to-head in the U.S. and Chinese glucagon-like peptide-1 receptor agonists (GLP-1RA) market for diabetes and obesity, Novo Nordisk is in innovator gear once more with leading studies of GLP-1s in Alzheimer’s disease. Read More
Intercept Pharmaceuticals Inc. lost its uphill battle to convince the U.S. FDA’s Gastrointestinal Drugs Advisory Committee that the risks of its second-line primary biliary cholangitis drug outweigh the benefits. The committee overwhelmingly said the data in the follow-up studies of treating the rare disease with Ocaliva (obeticholic acid), which has accelerated approval from the FDA, was insufficient. Read More
Immuneering Corp. CEO Benjamin Zeskind said he is “pleased with enrollment across the full trial” that’s ongoing with IMM-1-104 in cancer, and 30 subjects are due per arm in five arms that the phase IIa experiment includes. Read More
Imcheck Therapeutics SAS’s gamma-delta T-cell activating antibody has become a poster child for the French government’s plan to reduce dependence on imports of biopharmaceuticals by directly supporting domestic development and manufacture of 20 novel products by 2030. The Marseille-based company has been awarded nondilutive public funding of €20.18 million (US$22.4 million) as part of the €54 billion France 2030 strategy, which aims to restore the country’s industrial competitiveness. Read More
Despite heightened political tensions, both Chinese and U.S. industry officials are working to strengthen ties in the health care and biotech sector, including launching strategic initiatives to foster Sino-U.S. biotech investment and M&A deals. As one of the initiatives, representatives from Hong Kong, China and the U.S. convened at the Bio Hong Kong 2024 conference to launch a global health care M&A and financial investment alliance, along with fostering company and talent growth in Hong Kong. Read More
Three biopharmas debuted on Nasdaq Sept. 13, raising a combined $703 million for two Massachusetts-based companies focused on bifunctional antibodies for autoimmune diseases and cancer, and one Midwestern firm developing peptide therapies for endocrine and metabolic disorders. Read More
Biopharma deal values reached $14.88 billion in August, declining from July’s $20.86 billion but improving over June’s $12.79 billion. With a total of $135.17 billion raised through the first eight months, 2024 continues to hold the record for the highest year-to-date deal value in BioWorld's records. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aura, Gilead, GSK, Innovent, Monopar, Nkgen, QL, Seres, Sernova, Ultimovacs, Vyne. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Debiopharm, Emergent, Encell, Epitopea, ITM, Kazia, Lucy, Oncopeptides, Oncternal, Orano, Radiomedix, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Janssen, J&J, Neuraptive. Read More
