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Latest From Brenda Sandburg
CNS 'Graveyard Of Drug Development' Needs Oncology-Like FDA Regulatory Approach
Lundbeck executive calls for adaptive trial designs, transdiagnostic approach, and more scientific discussions between sponsors and the US Food and Drug Administration.
GSK Seeks To Halt Boehringer Promos That 'Denigrate' Effectiveness Of Ellipta, Diskus Inhalers
US FDA's wariness of taking enforcement action against Rx drug promotions may lead to more suits like GSK's. Complaint says healthcare providers are switching COPD patients to BI's Respimat inhaler in response to BI's marketing campaign.
Sanofi Pasteur Head Loew On The Vaccine Unit's Future Growth Drivers
David Loew talked to Scrip about the next-generation meningococcal vaccine candidate MenQuadfi and a monoclonal antibody that may be the first RSV treatment for infants.
No Shutdown But Funding Lower Than House Bill In US FDA Budget Forecast
Former Senate Appropriations Committee staffer expects FDA's FY 2020 budget will not be finalized until early next year and that it will be close to the sum in the appropriations bill passed by the Senate.
US FDA's Budget Forecast: No Shutdown, But Funding Down From House Mark
Former Senate Appropriations Committee staffer expects FDA's FY 2020 budget will not be finalized until early next year and that it will be close to the sum in the appropriations bill passed by the Senate.
'Super Dramatic' Ruling On PTAB Judges' Unconstitutional Status Will Have 'Limited Fallout'
Patent owners can challenge US Patent and Trial and Appeal Board's decisions on grounds the judges were not constitutionally appointed in a narrow number of cases, but they may have difficulty winning a different outcome.