The U.S. Center for Medicare & Medicaid Services (CMS) opened a 30-day comment window on its proposed national coverage determination (NCD) to limit Medicare access to monoclonal antibodies targeting amyloid beta in Alzheimer’s disease (AD) only in clinical trials. Biogen Inc., clearly the target, along with its AD treatment Aduhelm (aducanumab), was among the first to respond. Read More
Salarius Pharmaceuticals Inc. is joining the red-hot protein degradation space with an acquisition of a portfolio of oral small-molecule protein degraders and IP from Deuterx LLC it’s calling "transformative." The lead asset, SP-3164, is a cereblon-binding molecular glue that Salarius plans to move to the clinic in 2023 as a potential treatment for hematological cancers and solid tumors. Salarius paid Deuterx $1.5 million in cash and 1 million shares of restricted stock (NASDAQ:SLRX) up front, worth about $487,900 at market close on Jan. 13. Read More
Astrazeneca plc has announced two significant R&D deals with Scorpion Therapeutics Inc. and Benevolentai Ltd., which it hopes will sharpen its research into cancer, lupus and heart failure. Both of the deals involve artificial intelligence (AI) as a way to increase the probability of success during the clinical development process and reduce the chances of costly trial failures. Read More
Sana Biotechnology Inc. has acquired rights to two CAR T constructs through a pair of deals, one with partners Innovent Biologics Inc. and Iaso Biotherapeutics Co. Ltd. and a second with the U.S.-based National Cancer Institute (NCI). In the Innovent-Iaso deal, Sana secured nonexclusive commercial rights to a B-cell maturation antigen-targeted CAR T construct for in vivo gene therapy and ex vivo hypoimmune cell therapy applications. The NCI deal, for exclusive commercial rights to the NCI’s CD22 CAR asset, could help Sana “address key relapse challenges for CD19-directed CAR T-cell therapies,” the company said. Read More
Robert Califf moved a step closer to his second stint as head of the U.S. FDA when the Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-8 Jan. 13 to favorably send his nomination to the full Senate for a confirmation vote. Read More
LONDON – A population level study tracking every pregnancy in Scotland between the start of the pandemic in March 2020 and the end of October 2021 lays bare the devastating impact of COVID-19 on perinatal mortality. Read More
Hoping to improve Europe’s clinical trial environment, EU officials launched an initiative Jan. 13 to transform how clinical trials are designed and conducted. Read More
Olga Torres, co-owner of Miami-based Unlimited Medical Research, pleaded guilty Jan. 12 to obstructing a 2017 FDA inspection in connection with an alleged scheme to falsify data in a clinical trial evaluating an asthma drug for children. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alar, Arrowhead, Blade, Cyteir, Glaukos, I-Mab, IMV, Mesoblast, Pfizer, Revolution, Vaxxinity, Zai Lab. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Ascendis, Atai, Basilea, Cellular, Denali, Edesa, GSK, Hutchmed, Jeil, Mitsubishi, Novavax, Pharmather, Rockwell, SK, Vir.
