Given what CEO Raymond Stevens called a space that’s “evolving extremely rapidly,” Structure Therapeutics Inc. chose – rather than wait for next year’s 12-week data – to unblind the eight-week obesity findings with GSBR-1290, an oral glucagon-like peptide-1 (GLP-1) agonist for which the firm also provided a phase IIa update in patients with type 2 diabetes. Read More
Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The results could reach a vulnerable population of patients who are immunocompromised and don’t get the same protection as other patients, the company’s CEO, Dave Hering, told BioWorld. Read More
Neuren Pharmaceuticals Ltd. plans to progress NNZ-2591 to phase III trials following positive top-line phase II results in children with Phelan-McDermid syndrome, a genetic neurodevelopmental disorder for which there are no approved treatments. Read More
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. said it secured more than $100 million in an oversubscribed capital raise to advance CBL-514, its lead asset for subcutaneous fat reduction nearing phase III studies. Read More
More than 17,000 jobs losses were announced by 206 biopharma companies in 2023, down about 7% from the more than 18,400 workforce reductions attributed to biopharma last year. All told, there were 17,169 workforce reductions in 2023, not including undisclosed numbers. Read More
Both the U.K. MHRA and the U.S. FDA approved their first CRISPR-based gene therapy in 2023. Crispr Therapeutics AG and partner Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) was approved by the MHRA in November and the FDA on Dec. 8. The U.K. approval is for both severe sickle cell disease (SCD) and transfusion-dependent thalassemia (TDT). In the U.S., the approval is for severe SCD, with a PDUFA date for TDT coming up in spring 2024. Read More
Shares of Checkpoint Therapeutics Inc. dropped 44.8% Dec. 18 on news that the U.S. FDA issued a complete response letter (CRL), delaying potential approval of PD-L1 antibody cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA had accepted in March the BLA, seeking use for treating patients who are not candidates for curative surgery or radiation, setting a Jan. 3, 2024, PDUFA date. Read More
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. Read More
You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aadi, AC Immune, Carrick, Cullinan, Ensysce, Hansa, Immusoft, Karuna, Neurosense, Spago, Verrica, Wave Life. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anagenex, Attwill, Biocon, Biocytogen, Blue Water, Eli Lilly, First Wave, Genfleet, Immunogenx, Nimbus, Nuvectis, Ona, Onconetix, Organon, Point, Proteomedix, Replay, Revive, Sanofi, Syena, Verastem and Viatris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, CSL, Cymabay, JCR, Leo, Merck & Co., Sanofi, Takeda, US Worldmeds, Vertex. Read More
