Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
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
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a...more
On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU...more
On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were...more
The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more
As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more
The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions,...more
The European biosimilar market has expanded at record pace in 2017. The EMA approved marketing of sixteen biosimilar products referencing seven different innovator biologic products. For five of the innovator products –...more
On December 16, Celltrion announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Herzuma, its trastuzumab biosimilar. The...more
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more
Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more
Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more
The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more
The EMA announced on January 27 that Novartis and Sandoz have withdrawn their marketing application for their pegfilgrastim biosimilar (Zioxtenzo). The application was withdrawn after the Committee for Medicinal Products for...more
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more