The medical technology sector enters 2026 with strong fundamentals, sustained demand for innovative devices, and active dealmaking driven by technology advances, demographic pressures, and significant deployable capital....more
3/19/2026
/ Acquisitions ,
Due Diligence ,
EU ,
Food and Drug Administration (FDA) ,
International Trade ,
Medical Devices ,
Mergers ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Tariffs ,
UK
As readers will be aware, at the end of 2025, the EU institutions agreed the text of the EU Pharma Package: the wholesale change to the pharmaceutical regime in the EU that has been debated for many years. The changes...more
3/6/2026
/ Biosimilars ,
EU ,
Generic Drugs ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Legislation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Chain ,
UK
The UK Prescription Medicines Code of Practice Authority (PMCPA) has published revised social media guidance in a new dedicated section of its website, reflecting recent case precedent and the realities of an evolving digital...more
2/20/2026
/ Advertising ,
Compliance ,
Digital Health ,
Influencers ,
Marketing ,
New Guidance ,
Online Platforms ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Social Media ,
UK
At the end of 2025, the European Union advanced significant initiatives aimed at modernising and strengthening the regulatory framework for the life sciences sector. From the political agreement on the pharmaceutical package...more
2/5/2026
/ Biotechnology ,
EU ,
Healthcare ,
Innovation ,
Life Sciences ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements
The Morgan Lewis cross-functional and cross-jurisdiction life sciences and healthcare teams were represented in San Francisco for the 44th Annual J.P. Morgan Healthcare Conference from January 12–15, 2026....more
1/27/2026
/ Acquisition Agreements ,
Biotechnology ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investors ,
Life Sciences ,
Merger Agreements ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Venture Capital
The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and...more
1/9/2026
/ Centers for Medicare & Medicaid Services (CMS) ,
EU ,
European Commission ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare ,
Manufacturers ,
Medical Devices ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements
At the end of 2025, as part of a bundle of measures to make the EU health sector more innovative, competitive and resilient, the European Commission proposed the EU Biotech Act (the Act) aimed at repositioning the EU as a...more
1/6/2026
/ Artificial Intelligence ,
Biotechnology ,
Clinical Trials ,
Digital Health ,
EU ,
European Commission ,
GMO ,
Grants ,
Healthcare ,
Innovation ,
Pharmaceutical Industry ,
Proposed Legislation ,
Regulatory Reform ,
Research and Development
In a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a...more
Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical...more
A landmark agreement between the UK government and the US administration guarantees zero tariffs on UK pharmaceutical exports to the United States for at least three years in exchange for commitments from the United Kingdom...more
The European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the European database on medical devices (EUDAMED). EUDAMED collects and shares information on medical...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to introduce sweeping reforms for accelerating rare disease therapy development and approval, with the aim to position the UK as a...more