Triarm Therapeutics Ltd. is on a mission to democratize CAR T therapies to make them more accessible and affordable, Triarm CEO Jay Zhang told BioWorld. “Nearly half of the patients eligible for CAR T therapies still cannot get treated, and the main reason is the expense, and the second is they cannot afford to wait.
Regenerative medicine company Mesoblast Ltd. saw its stock shoot up 45% on the news that the U.S. FDA is satisfied with the additional data submitted from the company’s phase III study for remestemcel-L for treatment of adults with steroid-refractory acute graft-vs.-host disease (SR-aGVHD) to support filing a BLA in pediatric patients with SR-aGVHD.
Nuvation Bio Inc. said on March 25 it will acquire Anheart Therapeutics Ltd., a U.S.- and China-based precision oncology company, in an all-stock transaction, adding Anheart’s ROS1-inhibiting lung cancer drug, taletrectinib (AB-106), to its pipeline.
The U.S. FDA released two draft guidances in the third week of March 2024, one of which is a modest edit of an existing guidance for pre-submission activities between the agency and manufacturers.
The U.S. FDA granted Neuronetics Inc. clearance for use of its Neurostar advanced therapy as an adjunctive treatment of major depressive disorder in patients aged 15 to 21, making it the first transcranial magnetic stimulation treatment (TMS) cleared for this age group, the company said.
The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.
The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
Neuromuscular disease specialist NMD Pharma A/S has been given U.S. FDA approval for a phase IIb trial of NMD-670, after demonstrating proof of mechanism for the orally-available chloride ion channel-1 inhibitor in generalized myasthenia gravis.
Less than two years after acquiring Sound United for $1.025 billion, Masimo Corp. plans to hive off the consumer audio subsidiary along with consumer health products such as its Stork baby monitor and Freedom smart watch and band. The “rushed” announcement made Friday “came after being informed that Politan intended to nominate directors this week,” said activist investor Politan Capital Management. Politan, which owns 8.9% of the company, secured two board seats in a highly contentious proxy battle last year and nominated two more on Monday morning.
The U.S. Department of Health and Human Services (HHS) was quite vocal in its statement regarding a recent hospital cybersecurity breach, but HHS recently suffered an undisclosed data breach that cost $7.5 million in taxpayer monies.
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