The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
In Tuesday's Report: the expanding role of real-world evidence in FDA medical device submissions; President-elect Joe Biden lays out COVID-19 plan; Pfizer announces vaccine efficacy; and an analysis of material adverse change (MAC) clauses in Japan.
Tuesday, 10 November 2020
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Real-world evidence (RWE) has often been used to support the U.S. Food and Drug Administration's (FDA's) emergency use authorization of COVID-19 diagnostic tests, especially those authorized at the beginning of the pandemic. Use of RWE during the pandemic has demonstrated its utility in accelerating clinical development and ameliorating risks associated with traditional clinical trials (e.g., in-person trial visits), while maintaining the integrity of the clinical investigation. By forcing the FDA to become comfortable with the use of real-world data (RWD) in order to authorize COVID-19 diagnostic tests, the pandemic may have forced FDA to reflect in a more pragmatic way on what characteristics of RWE it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE. However, only time will tell if the FDA’s moderation during these exigent circumstances will open the door to more productive discussions on how RWE can develop into a mainstay for medical product development. We analyzed this trend for Med Device Online here. (Authored by Kelliann Payne, Blake Wilson, and Megana Sankaran)
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The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On 7 November, most major networks and news sources announced that Joe Biden won the presidential election to become the 46th President of the United States. Meanwhile, President Trump refuses to concede the election and has mounted several legal challenges in many states attempting to turn over Biden's wins. Yesterday, President-elect Joe Biden gave a COVID-19 briefing where he laid out his COVID-19 plan and how his transition team will take action as soon as Biden and Vice-President Elect Harris are sworn into office on 20 January 2021. Biden also pleaded with Americans to wear a mask and announced his COVID-19 Advisory Board. Pfizer announced Monday that that data from its trials show that its experimental COVID-19 vaccine “prevents 90% of people from catching the disease.” The U.S. surpassed 10 million confirmed COVID-19 cases on Monday, according to Johns Hopkins data. Read about these and other updates here: 5 Nov.; 6 Nov.; and 9 Nov. (Authored by Ivan Zapien)
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As was the case after the global financial crisis in 2008 and Japan's triple disaster in 2011, companies are turning their minds to their potential exposure to, or their ability to rely on, material adverse change (MAC) clauses in Japan in light of recent events surrounding COVID-19. In an M&A context, a MAC clause enables a buyer to walk away from a transaction before closing if an event or circumstance arises which has, or could reasonably be expected to have, a material adverse effect on the target company's operations and financial condition. Although the application of a MAC clause will largely depend on how the particular clause has been drafted, online here is a short overview of the some of the issues you may need to consider in assessing whether COVID-19 and its flow on effects could trigger a MAC clause on your transaction. (Authored by Jacky Scanlan-Dyas)
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