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Disclosure Requirements › Pharmaceutical Industry › Today's Popular Updates

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

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On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

K&L Gates LLP

Brussels Regulatory Brief: March 2021

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ANTITRUST AND COMPETITION - The European Commission Opens a New Investigation in the Pharma Sector - On 4 March 2021, the European Commission (Commission) has opened a formal investigation into alleged misuses of patent...more

The Volkov Law Group

Valeant Pharmaceuticals (Now Bausch Health) and Three Former Executives Settle SEC Cases

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Bausch Health agreed to pay the SEC $45 million to settle Valeant Pharmaceuticals (former name) accounting fraud schemes.  Three former executives, former CEO Michael Pearson, CFO Howard Schiller and Controller Tanya Carro...more

King & Spalding

HHS Issues Final Rule Requiring Disclosure of Partial Refills of Prescriptions to Help Curb Opioid Abuse

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On January 23, 2020, HHS issued its final rule adopting a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D.0, National Council for Prescription Drug Programs...more

Jones Day

Antitrust Alert: New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities

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Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar companies that relate to the...more

Jones Day

France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States

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On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more

Stinson - Corporate & Securities Law Blog

SEC Brings Enforcement Action for Disclosure Failures During Merger Talks

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The SEC announced that Allergan Inc. had agreed to admit securities law violations and pay a $15 million penalty for disclosure failures in the wake of a hostile takeover bid. The SEC’s order finds that Allergan failed...more

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