The FDA granted ImmunityBio's investigational candidate N-803 Breakthrough Therapy designation to be combined with Bacillus Calmette-Guerin to treat patients diagnosed with BCG-unresponsive non-muscle invasive bladder carcinoma in situ. The designation was granted based on data from early-stage and midstage trials.
China's National Medical Product Administration approved CASI Pharmaceuticals' application, filed by Juventas Cell Therapy, its partner, to launch the trial for its investigational therapy candidate CNCT19, or CD19 chimeric antigen receptor T-cell therapy, to treat relapsed or refractory B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. Enrollment is slated to begin early next year.
People with dementia-related psychosis who received Acadia Pharmaceuticals' Nuplazid, or pimavanserin, which had been approved by the FDA for Parkinson's disease-related psychosis, had a more than twofold lower psychotic relapse or worsening risk, while having similar odds of serious adverse events, compared with those who were given placebo, researchers reported at the Clinical Trials on Alzheimer's Disease meeting. FDA approval for the use of Nuplazid in dementia-related psychosis will be sought next year, according to Acadia.
Bristol-Myers Squibb announced that the FDA has granted its drug Orencia, or abatacept, Breakthrough Therapy designation as a treatment to prevent moderate to severe acute graft-versus-host disease in patients who received hematopoietic stem cell transplants from donors who are unrelated to them.
Atomwise and Stemonix have partnered to utilize their respective technologies to improve drug discovery and development. Stemonix develops organ models mimicking organs made from human induced pluripotent stem cells to be used to test potential drugs and will utilize Atomwise's deep learning techniques for this.
Japan's Consumer Affairs Agency announced that foods produced using gene-edited technology will not need to undergo safety inspections, though other biotech foods, such as those developed using genetic modification, must be tested for toxicity and carcinogenicity. The announcement also stated that these products' labels need not require a declaration that such technology was used to produce the said food item.
Medtronic entered an agreement in which its Integrated Healthcare Solutions unit will use the Lumeon CPM Platform, which includes chronic disease management and surgery optimization. The collaboration aims to support value-based care among European health care providers.
A recent round of post-approval studies showed that the survival rate of Abiomed's Impella RP heart pump remained steady when implanted in appropriately selected patients. Patients who would meet enrollment criteria for premarket studies had a 72.7% survival rate, compared with the 73.3% rate for those who participated in premarket studies.
Boston Scientific's Watchman heart implant demonstrated the lowest rate of hemorrhagic stroke recorded, with 95% of patients having discontinued anticoagulation drugs at one-year follow-up, according to a long-term study of registry data. Researchers said the data "support [left atrial appendage closure devices] as a safe and effective therapy for long-term anticoagulation in patients with nonvalvular atrial fibrillation."
An urgent field safety notice was issued by Terumo subsidiary MicroVention for certain lots of Azur endovascular embolization products because the devices may be missing the implant coil. Some lots of Azur peripheral coil system detachable 18 and detachable 35 are included in the notice.
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