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Hot Topics in International Trade A Year in Review (Quickly)
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. ...more
On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant...more
On August 18, 2025, Accord and Dong-A ST announced the U.S. launch of Imuldosa® (ustekinumab-srlf), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa® is approved for all the reference product’s...more
On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more
The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...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
The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more
On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more
On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more
The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more
The diabetes drugs Ozempic and Wegovy have been linked to an increased risk of sudden vision loss and blindness due to a rare eye condition known as NAION (non-arteritic anterior ischemic optic neuropathy)....more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more
Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more
On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more
Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services...more
AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more
Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more