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CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.
The head of the US arm of a major Korean government development institute talks to Scrip about why biotechs and pharma firms are flocking to Boston, how the organization is providing support and what the main challenges are.
While Daiichi Sankyo reveals ambitious plan with Enhertu, Chugai shows stable growth plans with COVID-19 drugs, Astellas reacted to concerns over Xtandi’s slow growth with enthusiastic investment plan for the next potential star.
Citing risk of thrombosis with thrombocytopenia syndrome, FDA restricts adenovirus-based vaccine to adults for whom other vaccines are not accessible or clinically appropriate, or who would not otherwise get a vaccine; action comes almost five months after CDC decided to preferentially favor the mRNA vaccines from Pfizer/BioNTech and Moderna.
- Drug Delivery