Taking The Pulse, A Health Care and Life Sciences Video Podcast | Episode 273: Navigating FDA Regulation for Life Sciences Companies with Christin Carey of Maynard Nexsen
Taking The Pulse, A Health Care and Life Sciences Video Podcast | Episode 271: Advancing Neurotrauma Treatments with Ken Webb of NeuroHope Therapeutics
False Claims Act Insights - $1.6 Billion FCA Judgment on Appeal: What it Means for FCA Enforcement
JONES DAY TALKS®: The CNPV Pilot Program: FDA's High-Speed Lane for Drug Approval
Pay Transparency + the Power of Preventive Strategies: Episode 3 — Pivoting Toward Preparation in the Life Sciences
Healthcare Trend Report: A Review of the Pharmacy and Drug Supply Chain Sectors
AI in Biotech: What Does it Mean for Life Sciences Innovation?
Wolf Greenfield Attorneys Review 2025 and Look Ahead to 2026
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 262: Breaking the “Undruggable” Barrier with Marcel Frenkel of Ten63 Therapeutics
What Life Sciences Investors Want
Navigating FDA's 2025 AI Guidance: Risk-Based Framework, Public Comments, and Generative Models - The Good Bot Podcast
Alumni Spotlight: Steve Brown
Where the Life Sciences Market is Headed in 2026
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 260: Innovation and Policy in Animal Health with Ron Phillips of the Animal Health Institute
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 259: The Patient Voice in Clinical Trials with Tom Croce of Jazz Pharmaceuticals
AGG Talks: Government Insight for Life Sciences Leaders | How Medicare Regulations Could Affect Access to Gender-Affirming Care: Implications for Life Sciences Companies
AGG Talks: Government Insight for Life Sciences Leaders | Patient Assistance Programs and the False Claims Act: Enforcement Trends and Compliance Risks for Life Sciences Companies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 257: Biogen’s $2B Investment in North Carolina’s RTP with Nicole Murphy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 256: AI, Advocacy & Clinical Trials with Sophia McLeod of ACRO
Daily Compliance News: October 6, 2025, The Corny Capitalism Edition
This case was filed in 2018 when Alvogen submitted to the FDA an ANDA for approval to market generic Belbuca, a buprenorphine buccal film used to administer the drug transmucosally....more
On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair® (omalizumab), TEV-45779....more
Find the 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 summary...more
On March 30, 2026, the FDA approved Teva’s biosimilar Ponlimsi™ (denosumab-adet), referencing Amgen’s Prolia® (denosumab), for all indications of the reference product....more
On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related macular degeneration...more
On April 2, 2026, Biocon filed a petition for post-grant review (“PGR”) challenging Regeneron’s U.S. Patent No. 12,168,036 (“the ’036 patent”), which is directed to methods for treating angiogenic eye disorders using high...more
Welcome to our Life sciences and healthcare insights report, where our global team share their insights on the most important commercial, legal, and regulatory issues facing life sciences and healthcare companies around the...more
On April 1, 2026,the U.S. Food & Drug Administration (FDA) issued a statement clarifying its compliance policy on the conditions that must be met for compounded drugs to qualify for the exemptions under Sections 503A and...more
Key Takeaways - HRSA has extended the deadline for comments on its proposed 340B rebate model pilot program to April 20, 2026. Covered entities have a limited window to submit detailed feedback on how the model would affect...more
Key Takeaways - Under the Section 232 national security authority, an additional 100% duty will apply to certain patented pharmaceuticals and associated ingredients, including active pharmaceutical ingredients and key...more
Over the past decade, the European Union has enacted a host of new legislation to protect the environment, promote sustainability, and tackle climate change, including the European Green Deal to new reporting and due...more
The UPC has been reshaping European patent litigation since its launch in June 2023. More than 480 patents have now been litigated in the court, and the number of actions is steadily increasing. Initially, major...more
The EU Commission published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) on December 16, 2025. After MDR and IVDR became...more
Heather and Matthew welcome Christin Carey, Maynard Nexsen’s newest FDA-focused life sciences attorney, for a discussion on regulatory developments shaping the life sciences and digital health industries. Drawing on her...more
Pharmaceutical research and development is becoming more expensive and taking longer. Innovative AI scale-ups and platforms are addressing this by quickly accumulating vast datasets, but the larger companies that buy them...more
The life sciences and healthcare sector is a prominent target for shareholder activists. In 2025 a record 255 activist campaigns were launched worldwide, surpassing the previous high of 249 set in 2018, according to research...more
Thanks to its scientific skills base, growing prowess in AI and a policy environment that supports rapid clinical trials, China has become one of the world’s leading markets for pharmaceutical innovation. Here we explore how...more
The U.S. Food and Drug Administration’s fiscal year 2027 budget justification includes more than 20 legislative proposals spanning drug and biologic approval pathways, supply chain oversight, advertising standards and...more
In Dealmaker’s Digest, read the top 10 latest developments in global transactions. We offer insights into M&A activity across industries and borders....more
In a previous case, the court entered final judgment that MSN’s ANDA product infringed claims 1-4 of the ’659 patent. In the current case, Novartis accuses MSN of infringing the same patent....more
In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to inspectional observations issued at...more
Customs and Border Protection (CBP) has announced that the first phase of the IEEPA tariff refund process will open on April 20, 2026, through its Consolidated Administration and Processing of Entries (CAPE) program in the...more
The New York Times reported on March 31, 2026 that the U.S. Food and Drug Administration is moving to lift its ban on more than a dozen injectable peptides that were restricted in 2023 over significant safety concerns. The...more
We have recently released the second edition of our Life sciences and healthcare insights report, where our global team explore the most important commercial, legal and regulatory issues facing life sciences and healthcare...more
There has been a recent and sudden uptick in enforcement from federal agencies against medspa prescribers. Specifically, the Department of Justice (DOJ) recently indicted a licensed osteopathic physician for allegedly...more
