Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more
1. CONTENTIEUX - NOUVEAU RISQUE DE REMISE EN CAUSE À POSTERIORI D’OPÉRATIONS NON NOTIFIABLES - Par une décision du 2 mai 2024, l’Autorité de la concurrence (ci-après l’ « Autorité ») a fait pour la première fois...more
RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more
In a long-awaited decision published on 31 May 2021, the IAA found that Leadiant infringed Article 102 TFEU through a multifaceted strategy that led to it obtaining an excessive price for its CDCA Leadiant® medicine. A number...more
1. BIS Eliminates Reporting Requirements for Certain Encryption Items Effective March 29, 2021, BIS eliminated or reduced reporting requirements for certain encryption items. For encryption source code and beta test...more
This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more
The Office of Inspector General (OIG) approved in Advisory Opinion 19-02 a pharmaceutical manufacturer's proposal to implement a loaner program involving limited functionality smartphones containing technology that is...more
More on yesterday’s news of a split power-generation division at GE, including why fixing the ailing business is such an important task for new CEO Larry Culp and what federal criminal and civil accounting probes mean for the...more
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
By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of the appellate Court of Padua in a case concerning the administrative...more
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more
A federal magistrate judge in California has allowed a securities fraud suit against a late-stage private company to proceed despite the plaintiff investors holding a security interest only through intermediary,...more
2016 was an active year for U.S. export control developments impacting U.S. pharma/device companies. We expect 2017 also to be busy, especially with the upcoming change in Administrations. This article briefly will review for...more
In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more
On Friday September 25, the PTAB issued its decision on Celgene’s sanctions motions seeking dismissal of five IPRs filed by Kyle Bass and his hedge fund Coalition for Affordable Drugs VI. In June, Celgene filed sanctions...more
Welcome to the August 2015 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange...more
Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more
In a recent order, the Patent Trial and Appeals Board (PTAB) indicated that it will consider a motion for sanctions based on a claim of “abuse of process” in Inter Partes Review (IPR) proceedings filed by the Coalition for...more
Welcome to the July 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, two Noble Corporation executives settle with the U.S. Securities and Exchange...more
Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more