Steve Usdin
Washington Editor at BioCentury
Co-Host at BioCentury This Week
Washington Editor, BioCentury. Author: Bureau of Spies & Engineering Communism.
Articles
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1 week ago |
biocentury.com | Steve Usdin
ARTICLE | Politics, Policy & LawBIO’s new board chair on MFN pricing, political realism, and why the industry can’t just say no anymore By Steve Usdin, Washington EditorFritz Bittenbender is taking on the job of BIO board chair at time when the biotech industry is facing public policy challenges across the value chain, from threats to the NIH funding of biomedical research that fuels early stage companies to the specter of international reference pricing crushing profitability.
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1 week ago |
biocentury.com | Steve Usdin
ARTICLE | Politics, Policy & LawThe former Amarin CEO and Merck executive is serving as an adviser to Commissioner Makary By Steve Usdin, Washington EditorFDA Commissioner Marty Makary has hired former pharmaceutical executive Karim Mikhail as a senior adviser and is considering appointing him as director of the Center for Drug Evaluation and Research, current and former FDA officials told BioCentury.
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1 week ago |
biocentury.com | Steve Usdin
ARTICLE | Politics, Policy & LawIndustry enthusiastic about streamlining reviews, concerned the program could become politicized By Steve Usdin, Washington Editor Biopharma executives applauded a pilot priority review pathway announced by FDA Commissioner Marty Makary Tuesday, anticipating streamlined reviews of innovative drugs, but some industry leaders, FDA officials and patient advocates privately expressed concerns.
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2 weeks ago |
biocentury.com | Steve Usdin
ARTICLE | Politics, Policy & LawFDA leaders planning biosimilars reboot, rolling submissions pathway By Steve Usdin, Washington Editor In a JAMA article published Tuesday and a webinar held Wednesday, FDA Commissioner Marty Makary and CBER Director Vinay Prasad outlined initiatives aimed at accelerating drug reviews, increasing competition, and advancing the Trump administration’s “most favored nation” drug pricing policies.
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3 weeks ago |
biocentury.com | Steve Usdin
ARTICLE | Politics, Policy & LawCBER Director Prasad says patients ‘deserve cures’ and FDA has an obligation to move fast — but personnel cuts could slow implementation of reforms By Steve Usdin, Washington Editor Eager to demonstrate tangible successes in speeding reviews of new medicines and clearing away outmoded regulatory barriers, FDA Commissioner Marty Makary and senior FDA leaders are prioritizing reforms to the regulatory framework for therapies to treat rare diseases.
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The death of a second boy in a trial of Sarepta’s DMD gene therapy is tragic. FDA Comm. Makary and CBER Dir Prasad have an opportunity to demonstrate leadership by investigating the unusual approval and charting a course forward for DMD patients. https://t.co/a16U4NJoC0
.@US_FDA's Makary, Prasad balance vows to speed reviews with industry criticism. Promise “massive” changes in biosimilars regulation and a new rolling submissions pathway, express support for Trump’s ‘most favored nation’ drug pricing policies. https://t.co/QitZKDfAqA
.@PearlF Brad Smith's conflicts have been known for some time. Here's an excerpt from a story (https://t.co/rHqusDgiAo) I wrote in February: https://t.co/YAw3bwbzSC