CHMP adopts negative opinion over osteoporosis drug Evenity
The agency said that as the benefits of Evenity did not outweigh its risks, it recommended refusal of the drug’s marketing authorisation. The marketing authorisation application (MAA) of
France-based biopharmaceutical company Osivax has entered into an exclusive license option agreement with Japanese vaccine manufacturer KM Biologics for a broad-spectrum “universal” influenza vaccine candidates in Japan.
A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial has met its primary endpoint by showing a statistically-significant and clinically-meaningful improvement in OS
IMB-115 is an internally discovered compound with a novel mechanism of action in clinical development for the treatment of insomnia disorders, including insomnia associated with alcohol cessation (IAAC).
The exclusive license agreement is for the development and commercialization of CPI-613 (devimistat), Rafael’s first-in-class clinical lead compound, which targets cancer metabolism enzymes, as well as its other