Chinese pharmaceutical and biotech companies are leading development of glucagon-like peptide-1 receptor agonists as Novo Nordisk A/S and Eli Lilly and Co. edge closer to launching blockbuster therapies in China. At the heart of the GLP-1 boom is a nationwide obesity problem driven by a confluence of factors, including the rise of a modern, sedentary lifestyle, according to Clarivate. Despite the rising prevalence of obesity and type 2 diabetes, the gap in obesity therapeutics is “substantial and leaves a solid market opportunity for weight loss drugs,” Karan Verma, principal analyst of healthcare research & data analytics at Clarivate, said. Read More
After missing the primary and secondary endpoints in its phase III study of losmapimod in treating the rare disease facioscapulohumeral muscular dystrophy (FHSD), Fulcrum Therapeutics Inc. is yanking the program’s plug. The selective p38α/β mitogen activated protein kinase inhibitor had a lot of money behind it. It was originally in-licensed from GSK plc and then, in May, Sanofi SA signed on to help Fulcrum develop and commercialize losmapimod for FHSD worldwide, excluding the U.S., in a deal worth $1.06 billion. Read More
Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma. Read More
Vironexis Biotherapeutics Inc. came out of stealth mode today, disclosing that it has more than 10 product candidates it’s been developing over the last three years. The therapies are built on the company’s AAV-based platform, Transjoin, which is designed to have patients' livers express bispecific antibodies that bind to both CD3 on T-cells and various targets on tumor cells. Read More
A novel gene therapy that leads to cellular rejuvenation could restore vision after non-arteritic anterior ischemic optic neuropathy (NAION) and glaucoma. The technique is based on a reprogramming process that reverses the epigenetic DNA alterations caused by aging. Preclinical studies in glaucoma mice and nonhuman primates (NHP) models for this stroke-like disorder that affects the eye, showed an improvement of vision and restoration of the damaged axons of the optic nerve. Read More
The BioWorld Drug Developers Index (BDDI) declined in August, ending the month down 1.11% for the year and diverging from its previous trend of mirroring the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA). By the close of August, the BDDI had slipped, while the NBI gained 11.7% year-to-date and the DJIA rose 7.05%. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Arecor, Apollomics, Avistone, Briacell, Biogen, Biothera, Bridgebio, Eli Lilly, Eupraxia, GSK, Hightide, Innovent, Johnson & Johnson, Merck, Oneness, Regeneron, Sanofi, Telix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Actuate, Agios, Bausch Health, Bridgebio, NS Pharma, Synerkine. Read More
