Brenda Sandburg
Senior Editor and Writer at The Pink Sheet
Senior editor @pharmapinksheet @Pharma_Intell. Cover pharma regulatory, policy & legal issues. All views my own. https://t.co/1JTWH6UfEy
Articles
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1 month ago |
espanol.medscape.com | Brenda Sandburg
Los estudios indican que tomar un suplemento de vitamina D puede ayudar a prevenir infecciones, fracturas y otras complicaciones tras una operación de prótesis de cadera o rodilla. Pero las pruebas son confusas y los médicos no recomiendan esta práctica de forma sistemática en el periodo perioperatorio.[1] Las guías existentes sobre el uso de la vitamina D no abordan los beneficios potenciales de la suplementación para mejorar los resultados tras una artroplastia.
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Oct 31, 2024 |
jdsupra.com | Brenda Sandburg
Life science companies will have to grapple with unique questions in complying with the European Artificial Intelligence Act, including the scope of the law’s research exemption and the use of AI in personalized medicine and real world-evidence. European Union lawmakers signed the AI Act, the first binding worldwide regulation on AI, in June. It was published in the Official Journal of the European Union on July 12, 2024 and entered into force across all 27 EU member states on August 1.
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Oct 18, 2024 |
insights.citeline.com | Brenda Sandburg
FTC Wins $448M Ruling Against AbbVie For Sham Litigation Rather Than Pay-For-Delay DealCourt finds AbbVie used sham litigation to maintain its monopoly on AndroGel but denies FTC request for an injunction; it is the largest monetary award in a litigated FTC antitrust case.
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Oct 18, 2024 |
insights.citeline.com | Brenda Sandburg
Patent Settlements: FTC Gets Teva To Eschew 'No-Authorized Generic' DealsGlobal settlement resolves charges against Teva in three pending FTC antitrust suits and expands terms of 2015 consent decree.
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Oct 18, 2024 |
insights.citeline.com | Brenda Sandburg
FTC’s Last Stand On Pay-For-Delay Deals? Supreme Court To Make Call On LegalityThe high court will determine whether brand-generic reverse payments to settle patent disputes are presumptively anticompetitive and unlawful when it takes up FTC v. Actavis; a ruling affirming the lower court would enable companies to enter agreements without the threat of litigation.
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This is outside the paywall. With more on Chevron oral arguments, mifepristone briefs and litigation over FDA's "you are not a horse" tweet. FDA’s Califf Is ‘Very Worried’ About Judges Overruling Agency Decisions :: Pink Sheet (https://t.co/rhgm5JRC0I)
https://t.co/X1D5F1a75q Colleagues note what made Sid Wolfe a gem. FDA also recognizes his commitment to public health. Story is free outside paywall.
It is so sad not to have Sid Wolfe in the world. He was a treasure and so wonderful to talk to about the history of FDA and the drug industry. I wrote a profile when he stepped down as director of HRG 10 years ago. https://t.co/Qt8coIcgi7