Hogan Lovells – Global Life Sciences and Health Care

We’re thrilled to announce that our China team is again ranked in Tier 1 for Life Sciences and Health Care: Foreign Firms, in the Legal 500 Greater China 2025 rankings, and this year, we are proud to be the only firm in this category! ?? Congratulations to the entire Greater China Life Sciences team and to Lu Zhou and Jessie Xie for their impressive individual rankings as Leading Partner and Leading Associate in this category. ? Thank you to our incredible clients for entrusting us with impactful projects. #LegalExcellence #legal500 #LifeSciences

In an article for Medical Devices Zone, Partner Michael Heyl, shares how he guides medical device companies through FDA regulations, requirements and compliance. This article shares tips on the importance of preparing for inspections and the value of strong internal auditing programs. Register here to read more: https://lnkd.in/eyYM_rgV #FDACompliance #MedicalDevices #Auditing

Join Partner, Fabien Roy on 21 November at The European Conference on the Future of AI in Healthcare as he presents on Successfully Navigating the MDR/IVDR and AI Act Requirements to Market AI Based Medical Devices in the EU. View the program and register here - https://lnkd.in/e4whyaRK #AI #MedicalDevice #Healthcare #AI4HealthCare

?? We were thrilled to host the Medical Device Manufacturers Association (MDMA) at our D.C. office for the 2024 MDMA Reimbursement & Health Policy Conference this week! Beth Roberts shared insights on TCET - Early Experiences, and Victoria Wallace discussed New Developments in Remote Monitoring and Artificial Intelligence Reimbursement. ?? Thank you to all who attended – we can’t wait to connect again at future events! #MDMA2024 #HealthPolicy #MedicalDevices

FDA recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices.?The meeting emphasized expanding inclusivity in the consent process, and ensuring a patient-centric approach, among other topics. We also note special considerations that were discussed for studies involving medical devices, especially for trials with long-term or permanent implants. Read more here: https://lnkd.in/eMUXA45t Authors: Robert F. Church, Heidi Gertner, Blake Wilson, Eman Al-Hassan, Sanchita Bose, Ashley Grey, Lauren Massie, and Evelyn Tsisin. #FDA #PatientEngagement #ClinicalTrials?

FDA issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) studies – during both development and post approval phases – for orally administered, immediate-release (IR) solid oral dosage drugs. It aligns with the International Council for Harmonisation’s (ICH) M13A guideline, which FDA adopted in August 2024. Read more here: https://lnkd.in/dKNVU628 Authors: Jason Conaty and Deborah Cho #FDA #M13A #Bioequivalence

We have advised EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT) on its US$161 million follow-on public offering of 14,636,363 shares of common stock at a public offering price of US$11.00 per share. Our Philadelphia-based team was led by partner Stephen Nicolai, senior associate Gibby Wagner, and associate Kayvon Paul. Learn more here: https://lnkd.in/evpaMPaJ #LifeSciences #HealthCare #Pharmaceutical #ClinicalStage #PublicOffering

This is the first article of a series that is designed to provide an insight on trademarks in the pharmaceutical sector. It will seek to give you an overview on the functioning of the European trademark system, of the challenges in finding, protecting and defending your trademark as well as the interdependencies with the market authorization procedures for medicinal products. Read more here: https://lnkd.in/emUb-43z Authors: Maria Luce Piattelli and Frederic Urbanek #PharmaProducts #EUTrademarks #IntellectualProperty

Through various recent evolutions, the economic situation of the pharmaceutical companies operating in France has become increasingly challenging. Read more here: https://lnkd.in/e4BpYwjX Author: Charlotte Damiano #PharmaceuticalCompanies

Supporting patient organizations financially is a common practice for pharmaceutical companies, with around 110 million euros spent in the EU and surrounding regions in 2022. However, recent media scrutiny raised concerns about the laws surrounding such sponsorships in Europe, and potential reputational damage. Companies must navigate EU anti-bribery laws, drug advertisement regulations, and tax laws to avoid monetary penalties. Reviewing compliance policies and providing employee training are essential to mitigate risks while supporting legitimate health care initiatives. Read more here: https://lnkd.in/eYHiXubh Authors: Désirée Maier, Arne Thiermann, and Dr. Hubertus Weber. #Pharma #CompliancePolicies #Healthcare