Price tag, inadequate trial designs, safety and questions about possibility of boosters were among the reasons CDC advisors voted that adults 60 and over ‘may’ receive an RSV vaccine. A stronger ‘should’ receive RSV vaccine had seemed possible for the over 65 group earlier this year.
GSK plc and Pfizer Inc. will likely have to work harder than they anticipated to get older adults vaccinated with the sponsors’ newly approved respiratory syncytial virus (RSV) vaccines following a US Centers for Disease Control and Prevention advisory committee’s lukewarm reception of the products on 21 June.
The CDC’s Advisory Committee on Immunization Practices voted 9-5 that adults 65 years of age and older may receive a...
The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.
Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
