Life Science Law Blog Archives - Asebey Law

FDA Resolves Semaglutide Shortage: What It Means for Ozempic®, Wegovy®, and Compounded Versions

Asebey Law — Thu, 06 Mar 2025 13:50:31 +0000

FDA Declares End to Semaglutide Shortage On February 21, 2025, the FDA issued a declaratory order announcing that the shortage of semaglutide injection products — namely Ozempic® and Wegovy® — has been resolved. Semaglutide, a GLP-1 receptor agonist used to manage type 2 diabetes, and obesity, had been in short supply since 2022 due to unprecedented patient demand. FDA confirmed that Novo Nordisk’s current production capacity now meets or exceeds both current and projected national demand, although some localized supply disruptions may still occur as products move through the supply chain. Compounding Pharmacy Exceptions: FDA Regulations, Drug Shortages, and Clinical...

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What is Trump’s Regulatory Freeze, and What Does It Mean for Federal Rulemaking?

Asebey Law — Wed, 05 Feb 2025 16:17:30 +0000

On January 20, 2025, President Trump issued an executive memorandum announcing a “regulatory freeze” that pauses all federal rulemaking activities across executive departments and agencies. Key highlights include: No New Rules Proposed or final rules cannot move forward until reviewed and approved by an appointee designated by the President. Exceptions may apply for emergencies or urgent circumstances, such as those with statutory or judicial deadlines, as determined by the Director or Acting Director of the White House’s Office of Management and Budget (OMB). Immediate Withdrawal Any rules submitted to the Federal Register but not yet published, or issued in any...

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Introducing the Life Sciences Law Blog

Asebey Law — Mon, 03 Feb 2025 16:43:54 +0000

Welcome to the Life Sciences Law blog — your resource for legal insights, regulatory developments, and policy trends shaping the life sciences industry today. In this space, we’ll explore how key issues impact FDA-regulated companies as well as the cannabis, hemp, and psychedelics industries. Writing about science and law is what we love to do. We’re not just here tracking headlines; We’re translating them into practical takeaways through a thoughtful perspective. Whether it’s exploring how biotech companies tackle clinical trial design, analyzing the latest developments in compounded GLP-1 regulations, or discussing emerging trends in psychedelics and cannabis, understanding not just...

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Veteran FDA Attorney Launches Boutique Life Sciences Law Firm, Asebey Life Science Law

Asebey Law — Wed, 23 Oct 2024 10:00:00 +0000

Firm integrates scientific knowledge and regulatory expertise to offer comprehensive legal solutions and scientific guidance to life science companies. FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Edgar J. Asebey, a seasoned attorney with over 20 years of FDA regulatory law experience, has launched Asebey Life Science Law, a boutique law firm specializing in FDA regulatory law, transactional law, and strategic advisory services for the life sciences industry. As a former scientist, biotech founder, venture capital fund advisor, and equity partner at an AM 100 law firm, Edgar is uniquely qualified to lead a firm that provides much needed regulatory guidance, enforcement defense and industry expertise...

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