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FDA takes major step to ease access to CAR-T therapy

BioPharma Drive: Drug Pricing

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements. Abecma and J&J’s Carvykti are used for multiple myeloma.

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Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.

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Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations

The Pharma Data

First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older Timely new data for the start of the influenza vaccination campaigns across the Northern Hemisphere. About the study.

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Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

The Pharma Data

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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First Single-Shot COVID-19 Vaccine for Adults 18 and Older in U.S.

The Pharma Data

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. “For

Vaccine 52
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PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

The Pharma Data

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable.

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OBI Pharma Announces Presentations at ESMO Asia 2020 Virtual Annual Meeting for OBI-833, a Novel Anti-Globo H Targeted Therapeutic Cancer Vaccine

The Pharma Data

These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. Department of Hematology and Oncology, Taipei Medical University Hospital, Taipei, Taiwan. About OBI Pharma.

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