Wandercraft SAS has begun commercial operations of its exoskeleton, Atalante X, in the U.S., offering another solution to the millions of people living with mobility impairments. The company also formed a partnership with the Kessler Foundation whose research team will investigate the possible benefits of the Atalante X for neurologically impaired patients, including those recovering from stroke, spinal cord injuries and motor neuron disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardioflow, Edwards Lifesciences, Spectral AI.
Caribou Biosciences Inc. has received FDA clearance of its IND application for CB-012, an allogeneic anti-C-type lectin-like molecule-1 (anti-CLL-1) chimeric antigen receptor (CAR) T-cell therapy. CLL-1 is highly expressed on acute myeloid leukemia (AML) cells and leukemic stem cells, but it is not expressed on hematopoietic stem cells.
A week before the U.S. Senate Health, Education, Labor and Pensions Committee is scheduled to vote on the confirmation of Monica Bertagnolli as the next NIH director, she faced a grilling by the committee fueled by drug pricing agendas and deals the Biden administration made with certain lawmakers to advance her nomination.
“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
To resolve a U.S. SEC insider trading charge related to Pfizer Inc.’s $11.4 billion acquisition of Array Biopharma Inc. in 2019, Brian Rubin consented Oct. 17 to a judgment ordering him to disgorge $90,458, plus prejudgment interest of $16,914, and to pay a civil penalty to be determined by the court.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Praxis Medical, Seastar Medical, Telesair, Vyspine.
Y-Mabs Therapeutics Inc. has received FDA clearance of its IND application for CD38-SADA, the company’s second program within its SAYA Y-PRIT (Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy) theranostic platform.
Bloomsbury Genetic Therapies Ltd. has announced U.S. and E.U. orphan drug designations for BGT-NPC, an investigational gene therapy for the treatment of Niemann-Pick disease type C (NPC). BGT-NPC is an investigational AAV9 gene therapy designed to provide a potentially curative solution to NPC patients following a one-time injection in the cerebrospinal fluid.
With an FDA approval decision on treosulfan possibly more than a year off, the U.S. Patent and Trademark Office granted Medac GmbH a third one-year extension of its method-of-use patent covering the drug, which is being developed as a conditioning agent in allogeneic hematopoietic stem cell transplantation.
RSS
