Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more
With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...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
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more
On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...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
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more
On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear." At...more
For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more
Late last year we reported on the United States Court of Appeals for the Federal Circuit decision holding that certain device patents should not have been listed in the FDA’s Orange Book since the claims of the patents in...more
Obesity and diabetes have been two of the greatest public health challenges for decades. Many different diets and fads have promised the public a quick fix and a path to losing excess weight or resolving their diabetic...more
In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more
On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab)...more
On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...more
Epaned® (enalapril maleate) - Case Name: Silvergate Pharms., Inc. v. Bionpharma Inc., Civ. Nos. 18-cv-1962, 19-cv-1067, 2024 WL 4417104 (D. Del. Oct. 4, 2024) (Goldberg, J.) Drug Product and Patent(s)-in-Suit: Epaned®...more
Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.) Drug Product and Patent(s)-in-Suit: Entresto®...more
Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.) Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...more
This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more
Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more
Oracea® (doxycycline USP) - Case Name: Galderma Labs., L.P. v. Lupin Inc., No. 2024-1664, 2024 WL 4998071 (Fed. Cir. Dec. 6, 2024) (Circuit Judges Moore, Linn, and Prost presiding; Opinion by Moore, C.J.) (Appeal from D....more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more
Surgimatix, our client spotlight this month, developed what can only be called a novel solution. Surgimatix is an early-stage medical device company pioneering the first proprietary laparoscopic device that delivers...more