HHS gives thumbs down to bluebird’s fertility support programme
The US government will not give bluebird bio the opportunity to offer fertility support to patients covered by federal insurance programmes like Medicaid.
24 July 2024
24 July 2024
The US government will not give bluebird bio the opportunity to offer fertility support to patients covered by federal insurance programmes like Medicaid.
A Phase II trial with J&J and Addex’s epilepsy drug had failed to meet the primary endpoint in April.
The acquisition of AbbVie’s clinical compounds enhances Sionna’s ability to address these challenges and solidifies its position as a potential future player in the CF market.
J&J's Tecvayli and Talvey are set to become the two top-selling BiTEs by 2030.
Telix is eyeing an expansion of the diagnostic imaging indications for its assets and advancing pivotal trials as the radiopharma arena heats up.
The latest resubmission addressed remaining CMC concerns, with the FDA confirming that the Phase III data was “sufficient”.
The approval for EPYSQLI is supported by comprehensive evidence, including analytical, non-clinical and clinical data.
The sNDA filing is based on the positive outcomes of the Phase IV TRD4005 study.
Merging industry-leading business intelligence & award-winning journalism, this is an unrivalled opportunity for engagement with B2B professionals across a network of 40+ leading media websites.
Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.
Give your business an edge with our leading industry insights.