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FDA-Nixed Language Can Be In Drug Promos, Expert Testifies


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FDA-Nixed Language Can Be In Drug Promos, Expert Testifies
Law360 (July 19, 2021, 9:29 PM EDT) A former FDA official testified in a California opioid trial Monday that it would not necessarily be a problem if drugmaker Endo s promotional material included a phrase that regulators had demanded be taken out of the product s official label.
Minnie Baylor-Henry, the director from 1995 to 1999 of the U.S. Food and Drug Administration s Division of Drug Marketing, Advertising, and Communications or DDMAC spent nearly a day on the stand as an expert witness for Endo, one of the drugmakers defending against four California jurisdictions claims that they ushered addictive drugs into the health care ecosystem and created a. ....

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Association between industry payments and prescriptions of long-acting insulin: An observational study with propensity score matching


Association between industry payments and prescriptions of long-acting insulin: An observational study with propensity score matching
Roles
Conceptualization,
Data curation,
Formal analysis,
Funding acquisition,
Investigation,
Methodology,
Validation,
Writing – review & editing
Affiliations
Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, Los Angeles, California, United States of America,
Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, United States of America
Roles
Conceptualization,
Funding acquisition,
Investigation,
Methodology,
Writing – review & editing
Affiliations
Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, Los Angeles, California, Unite ....

United States , Los Angeles , Aarons Kesselheim , Geralds Levey , Barbaraa Levey , University Of California , National Provider Identifier , National Center , Translational Science Institute Under Grant , National Institutes Of Health , Centers For Minority Aging Research Center , Translational Sciences , National Plan Provider Enumeration System , Centers For Medicare , Harvard University , United States Preventive Services Task Force , Medicaid Services , Open Payments , Creative Commons Attribution License , Physican Compare , Medicare Provider Utilization , National Institutes , Chronic Diseases , Minority Aging Research Center , Health Improvement , Minority Elderly ,

BioXcel Therapeutics Appoints June Bray to Board of Directors


BioXcel Therapeutics Appoints June Bray to Board of Directors
Former Allergan executive brings extensive global regulatory experience across multiple therapeutic areas
March 01, 2021 07:00 ET
| Source:
BioXcel Therapeutics
BioXcel Therapeutics
New Haven, Connecticut, UNITED STATES
NEW HAVEN, Conn., March 01, 2021 (GLOBE NEWSWIRE) BioXcel Therapeutics, Inc. ( BioXcel or the Company ) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the appointment of June Bray to its Board of Directors. Ms. Bray brings over forty years of extensive U.S. and global regulatory experience in the healthcare industry and most recently served as Senior Vice President, Global Regulatory Affairs and Medical Writing at Allergan. ....

John Graziano , Julia Deutsch , Mary Coleman , June Bray , Vimal Mehta , Actavis Forest Research Institute , Company Nasdaq , Bioxcel Therapeutics Inc , Hoechst Roussel Pharmaceuticals , University Of Rhode Island , Bayer Healthcare Pharmaceuticals , Regulatory Affairs At Organon , Fairleigh Dickinson University , Berlex Laboratories Inc , Global Regulatory Affairs , Xcel Therapeutics , Senior Vice President , Medical Writing , Chief Executive Officer , Drug Approvals , Forest Research Institute , Vice President , Regulatory Affairs , Berlex Laboratories , Rhode Island , Pharmaceutical Marketing ,