Regulatory

This target date is the latest development in a long series of setbacks that Acadia - and other pharma companies - have experienced getting Alzheimer’s treatments approved.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
China has become a leader in biotech in the last five years, especially in CAR-T therapies. Companies like Johnson & Johnson are on the prowl to acquire Chinese companies to form collaborations.
Robert Califf became the new commissioner of the U.S. Food & Drug Administration and emphasized the use of real-world evidence (RWE) in Agency decisions.
As COVID-19 cases fall in the wake of the latest surge from the Omicron variant, the question on the minds of many is, what comes next for these Pfizer and Moderna?
The FDA turned down Ocugen’s Emergency Use Authorization request for Covaxin in children 2 to 18, which the company is co-developing with India’s Bharat Biotech.
FDA
Pfizer announced its RSV vaccine candidate PF-06482077 or RSVpreF, received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
FDA
Belgium-based Celyad Oncology voluntarily paused a clinical trial with Merck after two deaths. Getting CAR T therapies to work in solid tumors has proven to be a difficult challenge.
It is unknown whether tightening economic sanctions will limit Russia’s ability to ship its vaccines to areas that do not have strong manufacturing capabilities.
Studies from Guttmacher Institute found that 54% of all abortions in the United States in 2020 were done with pills instead of surgery, an increase from approximately 44% in 2019.
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