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.

 

Key Considerations for U.S. Public Company Compensation Committees in Light of COVID-19

bottles and syringe

As the COVID-19 pandemic continues to unfold, U.S. public company compensation committees face unique challenges as they focus on retaining and appropriately incentivizing employees while evaluating the impact of the pandemic on the company.  This client alert provides a high-level overview of some key issues that compensation committees should be…

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U.S. Health and Human Services to Begin Disbursing $30 Billion of CARES Act Healthcare Provider Relief Fund

bottles and syringes

On Friday, April 10, 2020, the U.S. Department of Health and Human Services (HHS) announced it will begin disbursing $30 billion of the $100 billion of the Public Health and Social Services Emergency Fund recently allocated by the Coronavirus Aid, Relief, and Economics Security Act (CARES Act), signed March 27,…

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U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights

hands and test tube

Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs since that process was first established in 1972. The Act draws from recent legislative proposals to reform OTC regulation, incorporating…

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U.S. CARES Act Supply Shortage Provisions: What Drug and Device Manufacturers Need to Know

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On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion and concern over the availability and accessibility of critical medical devices, such as ventilators, and the…

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CMS Expands Availability of Advances on Medicare Reimbursement; U.S. CARES Act Increases Medicare Reimbursement Rates

Lady Liberty

In response to the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) announced on Saturday March 28, 2020, that it is expanding its Medicare Accelerated and Advance Payment Program (AAPP) to allow nearly all Medicare providers and suppliers to receive advances on future Medicare reimbursement. To…

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Collaboration, License and other Commercial Agreements: Key Considerations for Life Sciences Companies in the Age of COVID-19

hands and test tube

The COVID-19 pandemic is continuing to cause major global disruption to the activities of development stage and other life sciences companies due to, among other factors, limited or no access to clinical trial sites, reduced supply levels for active pharmaceutical ingredients or other key materials needed to make drug candidates…

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Labor Cost Reduction Options for Employers in a Distressed Economy: The CARES Act and Other Considerations

Lady Liberty

The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), which was enacted on March 27, 2020, created new programs and expanded existing programs in ways that significantly affect the options for employers. This alert identifies key aspects of the CARES Act that can affect employers’ decisions in managing payroll…

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The Impact of COVID-19 on Disclosure Obligations for Public Companies in the Life Sciences Industry

bottles and syringe

The ongoing global outbreak of the novel coronavirus (COVID-19) raises important considerations for life sciences companies subject to U.S. Securities and Exchange Commission (“SEC”) disclosure and reporting requirements. As the pandemic continues to disrupt markets and industries worldwide, companies should carefully assess the risks that COVID-19 poses to their operations,…

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U.S. Senate Passes CARES Act, Heads to House; Would Make Available to Small Businesses $349B in SBA Paycheck Protection Loans and $10B in Economic Injury Disaster Loan Grants

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Late Wednesday night, March 25, 2020, the U.S. Senate passed, 96-0, the “Coronavirus Aid, Relief, and Economic Security Act” or “CARES Act” (H.R. 748), which will make available to small businesses $349 billion in “paycheck protection loans” through the U.S. Small Business Administration’s 7(a) Loan Guaranty Program (Paycheck Protection Loans or PPLs) and $10…

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