Tweaks made to the design of the phase III trial called Phoenix (vs. the narrowly positive phase II Centaur study) with Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate plus taurursodiol) didn’t work. Now, the Cambridge, Mass.-based firm is facing possible withdrawal of the treatment from the U.S. and Canada, where it’s known as Albrioza. Shares of Amylyx (NASDAQ: AMLX) closed March 8 at $3.36, down $15.61, or 82.3%, after the firm disclosed top-line results from Phoenix, a global, 48-week, randomized, placebo-controlled phase III effort with Relyvrio, also known as AMX-0035. Read More
In February, the biopharma industry sustained the positive momentum observed in January, with total financings increasing 105.94%, reaching $22.3 billion compared to $10.83 billion the first month of the year. The amount positions February as the second-highest month in BioWorld’s records, trailing only May 2020, which saw $23.98 billion in total financings. Read More
A first-quarter 2024 launch for Alzheimer’s drug donanemab appears to be off the table as Eli Lilly and Co. disclosed a last-minute decision by the U.S. FDA to convene an advisory committee to review data from the phase III Trailblazer-ALZ 2 trial. Read More
In what was more of a campaign speech accompanied by frequent chants of “four more years,” U.S. President Joe Biden loaded the annual State of the Union address March 7 with what sounded like campaign promises for a second term. Among those promises were calls to Congress to expand the prescription drug price provisions of the 2022 Inflation Reduction Act. Read More
After spending 20 years at Novartis, Radiopharm Theranostics Ltd. CEO Riccardo Canevari told BioWorld that when he joined Radiopharm he wanted to focus on something different within radiopharmaceuticals where no one was playing. “I believe these new modalities are at the beginning of their potential, much like in the immuno-oncology space years ago. That’s a nice place to be,” he said, but it’s not only about competition, it’s also about understanding what other companies are doing and if there is a disease area or a mechanism of action that is not being explored, he said. Read More
Yuhan Corp., of Seoul, South Korea, added a new potential cancer drug to its oncology pipeline, licensing a son of sevenless homolog 1 (SOS1) inhibitor co-developed by Cyrus Therapeutics Inc. and Kanaph Therapeutics Inc. for ₩208 billion (US$156.3 million). Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Alphyn, Arch, Gabather, Gilead, GSK, Immuron, Nodthera, Persica, Salix, Ultimovacs, Upstream, Viiv. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3T, Ambrx, Astellas, Citius, J&J, Kronos, Merck. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Creative Medical Technology, Fresenius Kabi, Ionctura, Mind Medicine. Read More
