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 Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) have concluded a series of three listening sessions focused on competition in the pharmaceutical industry. ...more
On July 15, 2025, U.S. Senators Peter Welch (D‑VT), Josh Hawley (R‑MO), and Amy Klobuchar (D‑MN) introduced the ETHIC Act—the Eliminating Thickets to Increase Competition Act (S. 2276)—in the U.S. Senate. The bill is designed...more
On July 24, 2025, the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) convened the second of three public listening sessions aimed at identifying barriers to drug price competition in the U.S....more
On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Just before Americans celebrated the Fourth of July, on June 30, 2025, antitrust enforcers from both the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) hosted the first of two listening...more
In two recent public panels, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted the first of three joint listening sessions mandated by Executive Order No. 14273, Lowering Drug Prices by Once Again...more
Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a...more
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more
On April 15, 2025, President Donald Trump issued Executive Order No. 14273, “Lowering Drug Prices by Once Again Putting Americans First, ” which outlines a series of targeted actions to lower prescription drug costs and...more
On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more
Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more
The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food...more
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more
We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more
A Senate panel has advanced three sets of bipartisan bills purportedly aimed at reforming the intellectual property (IP) landscape and lowering the cost of prescription drugs. Together, these bills seek to address issues with...more
On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more
The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more
On October 31, 2024, the European Commission (the Commission) delivered its long-awaited decision in the Teva Copaxone case (which was published on April 8, 2025). Teva, a global pharmaceutical company, was fined EUR 462.6...more
Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
Oregon AG Dan Rayfield settled with AbbVie Inc. and Besins Healthcare, Inc. to resolve allegations that the pharmaceutical companies engaged in anti-competitive conduct relating to the sale of testosterone replacement gel in...more