Regulatory
A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.
The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.
The regulator has granted a priority review of the efficacy supplement for Sarepta Therapeutics’ gene therapy Elevidys with a target decision date of June 21, 2024.
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it.
Following a patient case of severe liver enzyme elevations, Inventiva is suspending its Phase III NATiV3 study in non-alcoholic steatohepatitis as Madrigal Pharmaceuticals awaits a March 14 PDUFA date.
The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.
While Gilead Sciences did not provide specific reasons for the halt, the company said it is “reviewing the benefit-risk” of its anti-CD47 antibody magrolimab across all ongoing trials.
In the next two weeks, the FDA is set to decide on a Humira biosimilar and a treatment for the negative symptoms of schizophrenia.
The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
PRESS RELEASES