Peptidream Inc. and Genentech Inc., a Roche Holding company, signed a deal worth up to $1 billion to discover and develop macrocyclic peptide-radioisotope (peptide-RI) drug conjugates. Peptidream, of Kawasaki, Japan, will use its peptide discovery platform system technology to discover, optimize and develop macrocyclic peptide candidates for use as peptide-RI drug conjugates against targets of interest to Genentech. Genentech will pay Peptidream an up-front payment of $40 million and up to $1 billion in potential development, regulatory, and commercial-based milestones. In addition, Peptidream is eligible to receive tiered royalties on net sales (ex-Japan) of any products arising from the collaboration. Read More
Merck KGaA has entered deals that could bring U.K. artificial intelligence companies Benevolentai Ltd. and Exscientia plc more than $1.2 billion. Oxford, U.K.-based Exscientia and Merck will collaborate to find three small-molecule candidates in oncology, neuroinflammation and immunology. Exscientia is getting $20 million up front and could bring in $674 million in milestones payments. Read More
“Why do the top 10 pharmaceutical companies remain in the top 10?” asked Li Chen, founder and CEO of Hua Medicine, to audience members at the Chinabio Partnering Forum in Shanghai on Sept. 20. “[It comes down to] their ability to innovate themselves, but also the capability to acquire technology from partnerships, [to] manufacture and sell in countries like the U.S." Read More
Shares of ARS Pharmaceuticals Inc. (NASDAQ:SPRY) plummeted 55.8% Sept. 20 on word that the U.S. FDA issued a complete response letter (CRL) for Neffy, despite receiving a recommendation for approval in May from the agency’s advisory committee (adcom) and following a three-month delay in action. Read More
Although preclinical studies of genetically engineered interleukin-18 (IL-18) historically indicated its potential in cancer treatment, interest in the cytokine languished after GSK plc shelved its IL-18 therapeutic on lack of responses in a phase II melanoma trial. But in 2020, Yale University-based professor of immunobiology Aaron Ring set about reviving IL-18 as a cancer therapeutic. He went on to engineer a decoy-resistant form of IL-18 and then founded Simcha Therapeutics Inc. to develop the drug – named ST-067. Read More
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].” Read More
The U.S. Centers for Medicare & Medicaid Services is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation. Read More
The impact of the U.S. Supreme Court’s full scope enablement ruling in Amgen Inc. v. Sanofi SA is reverberating through other genus patent challenges. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcturus, Arcutis, Aspargo, Astellas, Avacta, Caliway, Cerevance, Geovax, Immpact, Indaptus, Iveric, Revolution, Saol, Scancell. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 60 Degrees, AB Science, Astex, Atamyo, Beigene, Biophytis, Gilead, GSK, Intelgenx, Merck & Co., Otsuka, Pfizer, Rhythm, Viiv. Read More
