Aqilion AB has sold rights to its TAK1 inhibitors to Merck KGaA in an exclusive license and research collaboration agreement worth at least €960 million (US$1.03 billion) including potential milestones and royalties. The global giant will pay the Swedish biotech – which is headquartered in Helsingborg – €10 million in cash up front for the program and potential development and commercialization milestones and tiered royalties on worldwide net sales of more than €950 million. Read More
Erytech Pharma AS, repositioning itself to recover from a tough phase III cancer study failure in 2021, will merge with Pherecydes Pharma SA, which specializes in precision phage therapy for treating resistant and/or complicated bacterial infections. Read More
Psychedelic drugs may exert their effects at intracellular serotonin receptors that serotonin itself, which does not cross cell membranes, cannot reach. The findings were published in the Feb. 17, 2023, issue of Science by researchers from the University of California at Davis. An accompanying editorial by Evan Hess and Todd Gould at the University of Maryland School of Medicine called them “a key achievement in the understanding of the mechanism of action of psychedelics” and “an important step forward for a rapidly expanding and much-needed field of study.” Read More
The steadily percolating psychedelic drug space stands poised to generate a near-term stream of potentially encouraging developments in a range of mental health disorders, including depression, anxiety, post-traumatic stress disorder and more. Read More
If the Feb. 16 hearing before the U.S. Senate Commerce Committee is anything to go by, it’s almost a given that the bipartisan Pharmacy Benefit Manager (PBM) Transparency Act will eventually be passed by the Senate. But its journey through the Republican-controlled House could be more uncertain in light of growing concerns about an “activist agenda” at the FTC. Read More
After gaining emergency regulatory approval in Japan for its oral COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), Shionogi & Co. Ltd. is advancing several global phase III trials across a wide range of COVID-19 patient populations. Branded as Xocova in Japan, ensitrelvir received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare in late November 2022 for SARS-CoV-2 infection based on the results from phase II/III trials in non-hospitalized patients in Asia. Read More
The U.S. FDA granted Nanjing Iaso Biotherapeutics Co. Ltd. both regenerative medicine advanced therapy and fast track designations for its new drug, BCMA CAR T-cell therapy CT-103A (equecabtagene autoleucel), allowing it to speed up development and commercialization in the U.S. for the treatment of relapsed/refractory multiple myeloma. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, Coherus, Cytovation, Dilafor, Dr. Falk, Eluminex, Glycomimetics, Innovent, Junshi, Fortress, Helocyte, Renexxion, Small, VBI, Vyne. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Concert, Galera, Henlius, Kinnate, Redhill, Unravel. Read More