The company has filed a case with the U.S. FDA, alleging that due procedure was not followed in allowing rival Liquidia Corp’s application for a blood pressure drug.
Yesterday the company stated that Chief Operating Officer Robert Michael would succeed Richard Gonzalez to become the second-ever CEO of the drugmaker on July 1.
Despite this setback, AstraZeneca is looking to differentiate in the DKD space with its pipeline drug, zibotentan. If approved, having another treatment option could be of high value to physicians looking to find an optimal treatment of choice for individuals with DKD.
With the investment in the plant, Daiichi Sankyo is looking to create new laboratories for its antibody drug conjugates used to develop and manufacture therapies for breast, lung and stomach cancers.
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.
Rapt Therapeutics said on Tuesday the U.S. FDA had placed on hold two mid-stage trials of the company’s drug to treat eczema and asthma, after liver failure was observed in one of the patients.
The first human patient implanted with a brain-chip from Neuralink appears to have fully recovered and is able to control a computer mouse using their thoughts, the startup’s founder Elon Musk said late on Monday.
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.
As the last full month of winter 2024 nears an end, the FDA has two target action dates: one for a Humira biosimilar and another for a schizophrenia treatment.
The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the FDA’s approval was based on trials which extended median progression-free survival (PFS) by nearly nine months.
