Biopharma Competition FDA Safety 
pharmaphorum
JULY 1, 2022
billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.
Clarivate
OCTOBER 19, 2023
Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). For example, in the U.S.,
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Clarivate
OCTOBER 10, 2022
Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Fruquintinib will face fierce competition should it be approved in the third- and later-line setting.
Pharmaceutical Technology
DECEMBER 20, 2022
Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. McCall sees the whole experience as a positive one for biopharma: “When I started in industry, this type of data sharing and collaboration was unheard of.
Clarivate
OCTOBER 7, 2021
What’s new from ESMO: Interim efficacy and safety analysis from the randomized KEYNOTE-716 study showed that the trial met its primary endpoint of RFS, with patients receiving Keytruda presenting an RFS of 90.5% This novel antibody-drug conjugate (ADC)ADC faces much competition, should it be approved. at 12-months compared to 83.1%
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