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“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” said CDC Director Rochelle Walensky. Read More
Active pharmaceutical ingredient (API) manufacturer Bioiberica of Barcelona, Spain, was hit with a warning letter from the FDA for problems with contamination and lack of process controls. Read More
Labeling for proposed ready-to-use products that contain a range of drug strengths in a single container should contain instructions for determining the correct dose to be administered based on a patient’s weight or body surface area (BSA), according to a new FDA draft guidance. Read More
It’s getting crowded on the cell therapy bandwagon — and it won’t be able to hold many more passengers, according to a market analysis by GlobalData. Read More
Merck hit its second roadblock in a week, following the failure of its Lynparza trial with negative results in KEYNOTE-412, a phase 3 trial of Keytruda (pembrolizumab) in patients with unresected locally advanced head and neck squamous cell carcinoma. Read More
Following their three-year partnership, Ultragenyx Pharmaceutical has acquired GeneTx for an upfront payment of $75 million plus undisclosed future milestone and royalty payments. Read More