Takeda's direct-to-consumer TV ad for the insomnia drug Rozerem (ramelteon) fails to disclose the drug's indication, does not include information related to side effects and suggests through "back to school"-themed images and statements that the drug is indicated in children, FDA says in a warning letter issued to the company March 5 and posted online March 8
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
The first Phase III data for the CD38-targeting antibody is expected in 2027 in antibody-mediated rejection in kidney transplant patients, followed by other indications.
Novo Nordisk will partner with privately held Deep Apple to study a novel, non-incretin target that could be better suited than GLP-1s for long-term obesity treatment.
The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.
