Welcome to the Goodwin’s Life Sciences Perspectives Blog, a resource specifically aimed at addressing your most frequent and pressing issues and providing insights on current developments.

The challenges across the life sciences industry are as abundant as the opportunities. From tightening federal regulations and market forces to revolutionary innovations, the headwinds are stiff and shifting but they are navigable. We will be tracking emerging issues and developments on private and public company matters, licensing deals and collaborations, patent and IP matters, FDA and healthcare regulatory compliance, and European and Asian developments for life sciences companies. Sign up to receive postings from Goodwin’s Life Sciences Perspectives blog by clicking here.

 

Clinical Trial Diversity Planning for Sponsors: What to Know About FDA's Recent Draft Guidance

On April 13, 2022, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance providing specific recommendations to the industry on how to improve diversity in clinical trials. The FDA’s focus on increasing racial and ethnic diversity in clinical trials is not new, with the agency issuing several guidances since 2016…

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The Unified Patent Court is (Finally) Coming to Europe and Bringing Some Pretty Fundamental Changes with It

Seven years after the Member States of the EU signed the Agreement on a Unified Patent Court (“UPCA”), the Unitary Patent (“UP”) and the Unified Patent Court (“UPC”) are likely to commence during the second half of 2022. This promises to bring significant changes to patent protections across Europe, potentially…

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European Life Sciences Deal Trends

In Europe, life sciences deals increased over the last few years with a strong acceleration in 2021. As a result, the market wonders whether this is just a pick or rather a steady trend which will impact our market in the future as well. Analyzing the reasons of such growth…

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Draft Implementing Rules of China’s Human Genetic Resources Regulations as Applied to Foreign Persons

The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, have been in effect for almost three years. As the administrative department under the State Council with the primary responsibility for the administration and enforcement of the Regulations, China’s Ministry…

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President Biden Signs Into Law Medicare Telehealth Coverage Extension Post-Public Health Emergency

On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”).  Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional consultations, office visits, and office psychiatry services conducted via telemedicine for 151 days after the…

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CMS Continues to Modernize by Expanding Reimbursement for Digital Health Services

The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated to stay home across the country. Prior to the COVID-19 PHE, approximately 12,5000 Medicare beneficiaries received telehealth services and only…

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For Clinical Trial Recruiting, Words Matter

In a recent publication we helped co-author, we examined ClinicalTrials.gov entries and their possible impact on informing potential subjects of their eligibility to participate in clinical trials. In particular, we analyzed certain clinical trials focused on HIV treatment or prevention that allowed entry of pregnant women to assess the use…

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