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Client Alerts 30 results
Client Alert | 11 min read | 04.27.26
The New EU "Pharma Package": Access Conditionalities and Shortage Measures Compromise Proposal
In our seventh alert in this EU Pharma Package Series, we provided an analysis of the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the EU institutions.
Client Alert | 5 min read | 04.13.26
The New EU "Pharma Package": Global (Orphan) Marketing Authorization Compromise Proposal
In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
Client Alert | 3 min read | 04.07.26
The New EU "Pharma Package": Fiscal Imports in the Supply Chain Compromise Proposal
In our fourth alert in this EU Pharma Package Series, we provided an analysis of the long-standing but increasingly debated issue of fiscal imports in the pharmaceutical supply chain and the EU’s evolving approach to this issue.
Client Alert | 5 min read | 04.07.26
On April 2, 2026, President Trump issued a Proclamation invoking Section 232 of the Trade Expansion Act of 1962, as amended (19 U.S.C. § 1862), to impose tariffs on imports of patented pharmaceuticals, biologics, and associated ingredients into the United States. The action affects pharmaceutical manufacturers, importers, and supply chain participants.
Client Alert | 5 min read | 03.30.26
The New EU "Pharma Package": The Transferable Exclusivity Voucher Compromise Proposal
In our third alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission, the European Parliament , and the Council of the European Union on the transferable exclusivity voucher (TEV) for priority antimicrobials.
Client Alert | 5 min read | 03.22.26
The New EU "Pharma Package": Regulatory Data Protection Compromise Proposal
In our second alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission (Commission), the European Parliament (Parliament), and the Council of the European Union (Council) on one of the most debated and anxiously anticipated topics, the regulatory data protection (RDP). While all EU institutions proposed a modulation system, they differed significantly in terms of the baseline period and the structure of the possible extensions.
Client Alert | 3 min read | 03.02.26
Clinical trial sponsors and all other stakeholders involved in conducting commercial clinical trials of investigational medicinal products (IMP) in the UK.
Client Alert | 3 min read | 01.07.26
On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
Client Alert | 13 min read | 12.22.25
European Commission Proposes Biotech Act to Boost Health Biotechnology in the EU
On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.
Client Alert | 10 min read | 12.22.25
European Commission Proposes Simplifying the Rules on EU Medical and In-Vitro Diagnostic Devices
The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.
Client Alert | 6 min read | 12.15.25
The New EU “Pharma Package:” EU Reaches Landmark Deal on Pharma Package
On December 11, 2025, the Council of the European Union and the European Parliament reached provisional agreement on the long-awaited “Pharma Package,” (see the announcement here). The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, which replaces the more than 20-year-old Directive 2001/83 and Regulation 726/2004 and incorporates (and updates) the separate regulations on orphan and pediatric medicines (Regulations 141/2000 and 1901/2006 respectively).
Client Alert | 3 min read | 12.09.25
In an effort to boost its clinical research industry, Germany has enacted the Medical Research Act or “MRA” (Medizinforschungsgesetz). The MRA introduces significant changes to various German healthcare laws and procedures.
Client Alert | 3 min read | 11.20.25
Implications of CRISPR Dispute on Licensees
A decision in May from the Federal Circuit Court of Appeals has extended the long-standing and well-publicized dispute over inventorship of use of CRISPR-Cas9 technology in eukaryotic cells. When final resolution comes, it will have important implications for users of this technology. Companies currently licensing CRISPR-Cas9 from one of the two groups claiming ownership rights to the fundamental patents covering this technology and those considering licenses or investment in users of the technology should review existing or proposed licenses to better prepare for the potential outcomes of the dispute.
Client Alert | 3 min read | 11.06.25
Executive Branch Focus on Federally Funded Inventions
In recent months the executive branch has indicated a willingness to assert control over intellectual property funded by federal research dollars in novel ways. This could potentially include leveraging its march-in rights under the Bayh-Dole Act.
Client Alert | 9 min read | 10.15.25
Understanding the EU’s International Procurement Instrument
In June 2025, the European Commission adopted its first-ever measures under the International Procurement Instrument Regulation (IPI), restricting access to the EU public procurement market for medical devices for economic operators and medical devices from the People’s Republic of China. This is the first application of the IPI, a new trade instrument aimed at tackling lack of reciprocity in access to public procurement in third countries.
Client Alert | 3 min read | 10.13.25
Upcoming Massachusetts Pay Transparency Requirements
Commencing October 29, 2025, Massachusetts will join 14 other U.S. states in requiring certain employers to disclose wage pay ranges both in their public job postings and internally to employees who request the information. The requirement is mandated by the Massachusetts law entitled “An Act Relative to Salary Range Transparency” which aims to increase pay transparency and equity in the Commonwealth.
Client Alert | 2 min read | 10.03.25
On September 30, 2025, the Food and Drug Administration (FDA) issued a Request for Public Comment (“Request”) inviting stakeholders to share practical experience and recommendations for measuring and evaluating the real-world performance of AI-enabled medical devices, including those powered by GenAI. According to FDA, the Request is not intended to communicate new guidance or regulatory expectations but aims to advance the conversation on how best to assure the safety, effectiveness, and reliability of AI-driven technologies in clinical practice.
Client Alert | 2 min read | 09.18.25
On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”
Client Alert | 9 min read | 08.27.25
The New EU “Pharma Package”: Advertising – A Comparison of Commission/Parliament/Council Positions
In this ninth and final alert in our weekly series on the EU Pharma Package, we consider the proposals of the European Commission, European Parliament and the Council of the EU as regards the advertising of medicinal products and we conclude by suggesting various ways in which pharmaceutical companies can already prepare for the upcoming changes.
Client Alert | 13 min read | 08.20.25
In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. Our last alert looked at how the Pharma Package seeks to address these issues. However, the Pharma Package does not exist in isolation, and in this alert we will discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy.
