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?
The first half of 2025 has seen an acceleration of M&A activity, including large-scale life sciences transactions, such as Merck’s $3.9 billion acquisition of SpringWorks, Sanofi’s $9.5 billion acquisition of Blueprint...more
On July 16 2025, the Court of Appeal dismissed AstraZeneca’s appeal and upheld the first instance decision, finding that AstraZeneca’s compound patent for dapagliflozin, an SGLT2 inhibitor used to treat diabetes, was invalid...more
Insulet v EOFlow UPC_CoA_768/2024 (Ord_69078/2024) The Unified Patent Court (UPC) Court of Appeal has issued a significant decision that provides important guidance on the interpretation of patent claims in UPC...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The Economic Prosperity Deal agreed between the UK and the U.S. sets out high level trade commitments and areas for further negotiation between the two countries. A series of implementing measures are described in Executive...more
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria. ...more
Welcome back to the Class Action & MDL Roundup! This edition covers notable class actions from the first quarter of 2025. In this edition, two UK actions fail to clear a low bar, a movie isn’t a video, and spam isn’t...more
OVERVIEW - The UK Competition and Markets Authority (“CMA”) has recently published a decision accepting commitments from Vifor Pharma (“Vifor”). This brings to a close an unprecedented abuse of dominance investigation...more
On 16 June 2025, US President Donald Trump signed an executive order confirming and implementing parts of the US-UK Economic Prosperity Deal (“EPD Order”), following the announcement at the G7 Summit earlier this week....more
The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more
On May 8, the White House announced President Trump's first trade deal under his America First Policy. The deal struck between the United States and the United Kingdom will revise some of the tariffs imposed on the UK so far...more
This newsletter is a summary of the antitrust developments we think are most interesting to your business. Eliana Paredis (counsel based in Brussels) is our editor this month. She has selected: - European Commission kicks...more
While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more
The new US-UK Economic Prosperity Deal (“EPD”), announced last week (8 May 2025), is promising to bring back economic stability and will be welcomed by businesses at a time of increased geopolitical uncertainty....more
On May 8, 2025, the United States and the United Kingdom announced a new “trade agreement”. The Fact Sheet issued by the White House, can be found here. The Office of the United States Trade Representative has released the...more
Belgian Competition Authority Issues Fines for Category Management Agreement - On 24 April 2025, the Belgian Competition Authority (BCA) announced fines on three pharmaceutical manufacturers for what the BCA considered to...more
Just under two weeks ago, we reported the Court of Appeal had awarded AstraZeneca (AZ) a preliminary injunction in the UK against Glenmark’s generic dapagliflozin (dapa) product for type II diabetes, until the hearing...more
In a reversal of fortune, yesterday (9 April) the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel...more
On March 28, 2025, Michael Tappin KC, sitting as a deputy judge of the High Court, refused to grant AstraZeneca (“AZ”) an interim injunction to restrain Glenmark from launching in the U.K. a generic version of its type 2...more
On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more
The UK government plans to turbocharge the life sciences sector using policy levers to enhance research and development, innovation hubs, and private fundraising. In this piece, Michael Bloch explores how refinements to...more
The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close...more
On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more
Recent statements by President Trump suggest that next week could bring multiple and significant tariff announcements. Today, in a meeting with visiting Japanese Prime Minister Shigeru Ishiba, the President promised to...more
Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more