False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
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?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...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
Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...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
On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...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
Three Stelara® (ustekinumab) biosimilars launched in the U.S. in the past week, Alvotech / Teva’s Selarsdi™ (ustekinumab-aekn) on February 21, 2025, and Sandoz / Samsung Bioepis’s Pyzchiva® (ustekinumab-ttwe) and Biocon’s...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
The Biden administration recently determined that it has the right to seize patents covering certain high-priced medicines, in an apparent effort to take a more aggressive approach to lowering drug prices. See Targeting...more
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
Each fall, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments...more
For at least a decade, Congress has been concerned (not to say obsessed) with drug costs (understandably so, no matter how ineffective; see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more
Biologic drug makers will soon have to alert the Federal Trade Commission and Department of Justice of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement...more
Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and...more
On September 25, 2018, the House of Representative passed the “Patient Right to Know Drug Prices Act” (S.2554). As we previously reported, the Senate passed the bill on September 19, 2018....more