To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small to justify the costs. Neither Kisunla (donanemab, Eli Lilly and Co. Inc.) or Leqembi (lecanemab, Eisai Co. Ltd.), “demonstrate sufficient benefit to justify their high cost, including the cost of administering them,” the National Institute of Health and Care Excellence (NICE) concluded after an extended appraisal of the two amyloid neutralizing antibodies. Read More
The realignment within the U.S. FDA continued with reports of the removal of two high level executives. When asked by BioWorld if the Center for Biologics Evaluation and Research’s (CBER) Office of Therapeutic Products director and deputy director had been forced out and if so, why, an HHS spokesperson responded on background with a single sentence: “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.” Read More
One year after the FDA’s nod, the EMA is following on and recommending conditional approval of Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) as the first drug in Europe for treating noncirrhotic metabolic dysfunction-associated steatohepatitis. Read More
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient. Read More
The U.S. FDA clearance June 16 of CSL Behring LLC’s humanized anti-factor XIIa monoclonal antibody garadacimab (CSL-312) to prevent hereditary angioedema (HAE) attacks juiced up the space in which – although other therapies are available as well – developers continue working on new prospects. Read More
Shanghai Yao Yuan Biotechnology Ltd., also known as Drug Farm, is advancing a portfolio of immune-modulating therapies for various indications including hepatitis B virus, hepatocellular cancer and a relatively new rare genetic disease called ROSAH, an acronym for retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and headache. Read More
Keymed Biosciences Co. Ltd. has raised HK$982 million (US$125 million) in a placement on the Hong Kong Stock Exchange (HKEX:2162) to commercialize its IL-4Rα monoclonal antibody CM-310 branded as Stapokibart, and to advance its larger pipeline. Read More
Immuno Cure Biotech Ltd. is collaborating with Pharmajet Inc. to evaluate the safety and immunogenicity of its HIV therapeutic DNA vaccine, Icvax, delivered via Pharmajet's innovative Tropis needle-free injection system. Read More
Stay updated with BioWorld's latest index insights, featuring sector-specific charts that track the performance of companies in biopharma, drug development, cancer research, infectious diseases and neurological diseases. This page offers updates on index movement, as well as links to relevant stories about the biggest gainers and losers within each index. Explore the BioWorldindex insights page for in-depth, real-time data and performance analysis. Read More
New hires and promotions in the biopharma industry, including: Aligos, Applied, Atalanta, Avalo, Cardiff, Climb, Grin, Nervgen, Neurvati, Nob Hill, Rewind, Sinovac, Sling, Tolremo. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aptevo, Camurus, F2G, Galderma, Oncoinvent, Scholar Rock, Shionogi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioaegis, Diagonal, Medicovestor, Moleculin, Senti. Read More
