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.

 

Update: How Life Sciences Companies Can Assess Stay-At-Home Restrictions in MA and CT

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Over the past week, the governors of several states have issued “stay-at-home’ orders to combat the spread of the coronavirus known as COVID-19. These stay-at-home orders significantly limit freedom of movement within the affected states and instruct businesses to institute remote work solutions for their employees—or else to shut their…

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COVID-19: Business Interruption and Insurance Amid a Pandemic

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Businesses in the United States and around the world are undergoing a fundamental and unprecedented disruption as a result of the coronavirus pandemic (COVID-19). State governments have issued “shelter-in-place” and “stay-at-home” orders to the general population, postponed or otherwise cancelled schools in full, and shut down all businesses except those…

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Conduct of Clinical Trials During the COVID-19 Pandemic: Recommendations from FDA

As the COVID-19 pandemic unfolds, our drug, biologic, and medical device clients conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or access restrictions, infection transmission concerns of site research personnel and study subjects, and supply chain interruptions. Nonetheless, it…

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The Implications of Coronavirus (COVID-19) On Contractual Performance and Negotiations

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We encourage our clients to be proactive in responding to the potential impact of COVID-19 on both existing and potential business agreements and relationships. Now that the World Health Organization has formally classified the outbreak of COVID-19 as a pandemic, and the full spread of the virus remains uncertain, it…

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Racing Against COVID-19: An Introduction to China's Regulatory Fast-Track Processes

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In response to the outbreak of a pneumonia-like disease caused by coronavirus (COVID-19), Chinese regulatory authorities adopted a few emergency measures under certain “Special Review and Approval Procedures” to fast-track the review and approval process for developing diagnostic kits, vaccines and therapies for combating COVID-19 infections. There are several types…

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