It will be difficult to compare Moderna, Inc. and Pfizer Inc.’s coronavirus vaccines based on their Phase 3 study designs, some vaccines experts said. “Both trials appeared to be well designed,” based on publicly available information, said Ira Longini, co-director of the Center for Statistics and Quantitative Infectious Diseases Emerging Pathogens Institute at the University … Continue reading “Moderna, Pfizer Protocols May Make COVID Vaccines Hard to Compare”
Author: Sarah Karlin-Smith
Sarah Karlin-Smith covers regulation of the pharmaceutical industry for the Pink Sheet.
Moderna: Speed of COVID 19 Vaccine Hinges On Enrolling Right Patients
Fast enrollment of the right patient populations will be critical to quickly conducting Phase III trials of COVID-19 vaccines and this will likely mean taking concerted steps to reach out to populations that can be harder to recruit for clinical trials, drug industry leaders said on a recent New York Academy of Sciences webinar. Moderna … Continue reading “Moderna: Speed of COVID 19 Vaccine Hinges On Enrolling Right Patients”
Antibiotic Development: HHS Not Yet Sold on “Pull” Incentives
The US Health and Human Services agency isn’t ready to go all in on “pull” incentives to encourage the development of new antibiotics, the agency indicated in response to a new Government Accountability Office report. “It is still unclear whether post-market financial incentives should necessarily be part of HHS’s forthcoming strategic framework to further incentivize … Continue reading “Antibiotic Development: HHS Not Yet Sold on “Pull” Incentives”