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?
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
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 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
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
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more
The Federal Circuit’s March 21, 2025 decision in Maquet Cardiovascular LLC v. Abiomed Inc. et al. (No. 2023-2045) and the recent Patent Trial and Appeal Board (PTAB) Delegated Rehearing Panel decision in SynAffix B.V. v....more
Federal Circuit reshapes foundational requirements for viability of a case in the ITC - Pharmaceutical and life sciences companies have historically been rare participants before the International Trade Commission (ITC) – in...more
United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of...more
On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...more
The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...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
On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.”...more
The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more
Drugs are bad, m’kay. But what if they’re not? Psilocybin continues to be in the limelight for its potential medicinal uses, including most particularly its potential to combat the nation’s growing mental health crisis. Last...more
A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more
On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
When direct-to-consumer genetic testing company 23andMe Holding Co. and its affiliates (together, “23andMe”) filed for chapter 11 bankruptcy on March 24, 2025, they possessed data from over 15 million customers. Specifically,...more
Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and...more
Over the past few years, we have been deeply engaged in – and have closely observed – the rapid growth of Chinese biotech companies. Despite a challenging market environment, these companies have continued to make remarkable...more
On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The...more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
Over the past decade, the global pharmaceutical industry has witnessed a transformation in the treatment landscape for metabolic disorders, particularly type 2 diabetes and obesity. At the heart of this shift is the explosive...more
This latest edition features articles on succeeding in the current life sciences funding market, strategic and legal considerations in digital health combinations, the corporate practice of medicine and guidance for...more
