The latest global regulatory news, changes and updates affecting biopharma, including: WHO: Antibiotic pipeline nearly static, Canada creates new drug safety net, CDSCO provides guidance on COVID-19 vaccines.
The current pause on administering Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine likely will continue in the U.S. after the CDC’s Advisory Committee on Immunization Practices (ACIP) declined to make a recommendation on a path forward April 14.
“There is a big need for a drug in outpatients. If you could treat them and keep them out of hospitals, that would be important and play a big role in getting us through this pandemic,” Romark Laboratories LC’s CEO, Marc Ayers, told BioWorld.
More than a quarter of all biopharma/nonprofit deals and grant awards in 2021, as well as 79% of the disclosed funding, targets the COVID-19 pandemic, following a trend that began in the early months of last year as SARS-CoV-2 reared its ugly head.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve Life Sciences, Agenus, Aligos, Ardelyx, Ascletis, Astrazeneca, Auris, Endo, Galectin, Gannex, Innocoll, Kyowa Kirin, Moderna, Nervgen, Orphomed, Proqr, Rocket, Romark, Synthetic Biologics and Veracyte.
The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.
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