BioVie has blamed “protocol deviations” at a number of clinical trial sites for the failure of a potential Alzheimer’s disease drug while claiming that the evaluable data still shows the candidate improves cognitive function.
Karuna Therapeutics officially has its date with the FDA. The agency will decide on the approval of KarXT for schizophrenia by Sept. 26, 2024.
Eli Lilly’s recent growth has been evident in all corners of the business: from its value and size through to its long-term ambitions. The company’s physical footprint has also expanded and is continuing to do so.
Thermo Fisher Scientific has had a longstanding agreement with Flagship Pioneering to help supply the incubator’s roster of young biotechs with life sciences hardware and research services. Now, Thermo Fisher is getting in on the startup game itself.
The GLP-1 receptor agonist drug class became a household name almost overnight thanks to the success of Novo Nordisk’s semaglutide, marketed as Wegovy for weight loss and more recently as Ozempic for type 2 diabetes. But while GLP-1s stand to rake in billions of dollars for the pharmas that make them, long-term adherence to the drugs is less than ideal, some clinical data suggests.
As if biotechs needed any more bad news, CAR-T therapy companies saw shares tumble on the news that the FDA will investigate the “serious risk” of subsequent, secondary cancers that can occur after treatment with the therapies.
Medtronic has launched a heart implant designed to help lower the lifetime risk of stroke in people with atrial fibrillation and to serve as a valuable addition to patients who are already undergoing open cardiac surgery.
CAR-Ts targeting a ‘special’ solid tumor antigen work well in some mouse models, but challenges remain
Chimeric antigen receptor T cell (CAR-T) therapy has dramatically improved the odds for patients with blood cancer, boosting survival rates from 15% to 40% for some types. But despite ongoing efforts from scientists, biotechs and Big Phama, the same success has yet to be replicated in solid tumors.
Aldeyra Therapeutics had prepared for the worst and now it’s here. The FDA has rejected the dry eye drug reproxalap.
Boehringer Ingelheim will harness an artificial intelligence model trained in the computer labs of IBM as the German drugmaker becomes the latest Big Pharma to apply machine learning tools to its drug discovery efforts.