Novartis Pharma AG continues to build up its radiopharmaceutical powerhouse and has expanded a peptide discovery collaboration with Peptidream Inc. in a deal worth up to $2.71 billion. Under the multi-program agreement, Kawasaki, Japan-based Peptidream will use its peptide discovery platform system technology to identify and optimize novel macrocyclic peptides against targets selected by Novartis for potential conjugation to radioligand therapies or other applications for both therapeutic and diagnostic purposes. Read More
As Poseida Therapeutics Inc. anticipates reporting further data this year from allogeneic CAR T-cell therapy P-MUC1C-ALLO1, for which Astellas Pharma Inc. has nabbed first negotiation rights, the two companies inked a second deal aimed at combining their respective cell therapy platforms in an early stage collaboration targeting solid tumors. Read More
While Nrx Pharmaceuticals Inc.’s oral antidepressant NRX-101 failed, producing a not statistically significant 33% reduction in suicidality along with a 70% reduction in the symptoms of akathisia, the company said it plans to forge ahead and conduct a registrational study. Read More
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products. Read More
The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome. Read More
BioWorld’s three-part series takes a deep dive into CAR T therapy development and investment in mainland China. The report examines the growing interest in CAR T therapy, an approach to cancer treatment designed to harness the power of the body’s immune system, looking at the rapid pipeline growth, investments and dealmaking, clinical trials and challenges surrounding patient access.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alumis, Arsenal, Aurion, Biora, Debiopharm, Foresee, Inmune, Mannkind, Nacuity, Nanoviricides, Recce, Repare, Terns, Vaxart. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Aurinia, Discovery, Eton, Genmab, Ingenium, Nanjing Leads, Replay, Shenzhen Chipscreen, Wave Life. Read More
