Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Drug Pricing Initiatives During the Trump Presidency
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
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more
West Virginia Attorney General (AG) Patrick Morrisey announced a total $17 million settlement agreement with pharmaceutical companies, Pfizer and Ranbaxy after more than a decade of litigation regarding the companies’ alleged...more
A bipartisan coalition of 50 states, D.C., and two territories reached settlements with Heritage Pharmaceuticals, Inc. and Apotex Corp. to resolve allegations of price fixing generic drugs in violation of the Sherman Act....more
Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more