Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration. Read More
After many months of jockeying, the U.S. FDA has approved Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) for treating hypoparathyroidism. Ascendis said this is the first and only treatment for adults with the rare endocrine disease. Read More
Merck & Co. Inc. is acquiring Curon Biopharmaceutical Ltd.’s bispecific antibody CN-201 that targets CD3 and CD19 for B-cell associated diseases, for up to $1.3 billion. Under the terms of the deal, Merck (known as MSD outside of North America) through a subsidiary will acquire full global rights to CN-201 for an up-front payment of $700 million in cash. Curon is also eligible to receive up to $600 million in development and regulatory-based milestone payments. The deal is expected to close in the third quarter of 2024. Read More
Executives of ARS Pharmaceuticals Inc. are anticipating a quick switch for severe allergy patients following the U.S. FDA approval of Neffy (epinephrine nasal spray 2 mg), marking the first needle-free treatment option. Read More
The BioWorld Cancer Index (BCI) finished July down 3.94% for the year, maintaining its downward trend after reaching a high of 11.07% at the end of February and closing in March with a 3.92% gain. In comparison, the BCI underperformed the Nasdaq Biotechnology Index, which climbed 10.82%, and the Dow Jones Industrial Average, which posted an 8.37% increase over the first seven months of the year. Read More
Cullinan Therapeutics Inc. terminated development of Harbour Biomed Holdings Ltd.’s bispecific B7H4 x 4-1BB immune activator, CLN-418 (HBM-7008), after reviewing phase I data. Read More
In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AN2, Avidity, Cantargia, Kiromic, Neuren. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS Pharma, Ascendis, Crispr, Humacyte, Sandoz, Scpharmaceuticals, Shanghai Junshi, Vertex, Wave Life. Read More
