Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
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?
In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more
On June 28, 2024, the United States Patent and Trademark Office (“USPTO”) requested the public’s views on the current state of the common law experimental use exception to patent infringement and whether legislative action...more
The Ministry of Health launches the prior public consultation to update the regulatory framework applicable to the advertising of medicinal products. Until 1 May 2023, anyone interested in this regulatory initiative may...more
The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medical devices. The Spanish Health Act gives the authorities control over health advertising. In particular, Article 102...more
The Annual Regulatory Plan for 2023 recently released by the Spanish Government provides for important regulatory changes and developments in the area of medicinal products, including pricing and reimbursement or health...more
The Spanish Data Protection Authority published on Friday on its website the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance"...more
The debate in Spain on the possibility of promoting medicinal products in the period between marketing authorization and pricing & reimbursement has recently taken on a special prominence. The Spanish market has been...more
Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more
The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more
In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...more
The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more
The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more
According to the new Order SND/354/2020 of 19 April issued by the Spanish Ministry of Health, the pricing authority has 48 hours to set the maximum retail price of surgical masks, nitrile gloves, hygienic masks, antiseptics,...more
The Spanish Ministry of Health placed on manufacturers and marketing authorization holders (MAHs) – or their local representatives – new reporting, supply, and manufacturing obligations with respect to 347 medicinal products...more
With more than 17,000 people currently infected in Spain, the national government has granted the Ministry of Health far-reaching powers to contain the coronavirus, and has issued several orders to safeguard the economy....more
On 3 March 2020, the Spanish Council of Ministers, based on Article 3(3) of the Spanish Regulation on Medicinal Products (RDL 1/2015), agreed on a new economic regime for orphan medicinal products. ...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more
Earlier this week, Sandoz announced the launch of its adalimumab biosimilar, HYRIMOZ, in 40-mg doses for subcutaneous injection in either a syringe or prefilled pen, in Spain. As we reported earlier, Sandoz previously...more
On September 26, 2018, the EU General Court (the Court) upheld the European Commission’s refusal to reinvestigate GlaxoSmithKline SA’s (GSK) Spanish “dual-pricing” distribution arrangements, 20 years after the alleged conduct...more
U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
"Spain is waiting for the EMA. Barcelona is ready". With this conviction, and with the conviction that everything is ready, the Spanish Minister for Health addressed the European Commissioner for Health & Food Safety, Mr...more
The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more
In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more