COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

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The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.

In Tuesday's report: FDA to resume inspections, an SEC guidance tracker, U.S. proposes $25B for vaccine development, and other Congressional updates.

Tuesday, 14 July 2020

  • The U.S. Food and Drug Administration (FDA) said Friday it plans to resume on-site inspections of FDA-regulated facilities and other associated activities the week of July 20, 2020. The agency had temporarily halted most domestic facility inspections on March 18, 2020, as part of the government’s response to the COVID-19 pandemic. FDA has been conducting limited mission critical inspections over this period. FDA plans to use its new COVID-19 Advisory Rating system to determine where it will be safe to conduct pre-announced domestic inspections moving forward. Read more here. (Authored by Jim Johnson)

  • Our Public Company Advisory practice has developed this quick-reference guide for U.S. public companies navigating the rapidly evolving regulatory landscape which continues to impact SEC filing and disclosure obligations, shareholder meetings, listing standards, capital raising, and other regulatory and governance matters. This guide briefly summarizes recent regulatory developments from the SEC, NYSE, and Nasdaq in response to the COVID-19 pandemic and certain other COVID-19-related developments. (Authored by Jo Broadbent)

  • 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. Education Secretary Betsy DeVos is defending President Trump’s push to reopen schools this fall despite the surge in COVID-19 cases. The media is reporting that the White House is trying to undermine the reputation of Dr. Fauci as he continues to disagree with President Trump on the COVID-19 crisis. White House officials have been distributing misleading “opposition information” on Dr. Anthony Fauci. Former White House Chief of staff Mick Mulvany wrote an op-ed for CNBC criticizing the U.S. testing process and calling on another round of stimulus that should focus on the root cause of fighting COVID-19. Senate Democrats released proposals in eight key policy areas that are crucial to ensuring one or more safe, effective COVID-19 vaccines that are produced, distributed, and administered widely enough to end the COVID-19 pandemic. Minority Leader Chuck Schumer (D-NY) and Senate Health, Education, Labor and Pensions (HELP) Ranking Member Sen. Patty Murray (D-WA) released the “roadmap,” which includes $25 billion in new emergency funding to support vaccine development in the next coronavirus relief package. Read about these and other updates online here. (Authored by Ivan Zapien)

 

Monday, 13 July 2020

  • 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. Sens. Ben Cardin (R-MD) and Marco Rubio (R-FL) led a letter from a group of 31 senators calling on Senate leadership to include an international response to COVID-19 in the next coronavirus package. National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said states needed to pause reopening efforts. “Rather than think in terms of reverting back down to a complete shutdown, I would think we need to get the states pausing in their opening process,” he told The Hill. Fauci’s comment differs from the previous one he made a day earlier in a Wall Street Journal interview when he said states “should consider” shutdowns. Almost 100 members of Congress are demanding the Trump administration halt its order to deport any international students whose coursework is being moved completely online, according to a letter led by Sen. Elizabeth Warren (D-MA) and Rep. Ayanna Pressley (D-MA) to the heads of Department of Homeland Security (DHS) and ICE. On 9 July, former Vice President Joe Biden laid out how his administration plans to handle the coronavirus and the resulting beleaguered U.S. economy. His plans include “multiple scenarios” on a COVID-19 vaccine, federal guidance, and bolstering the U.S. supply chain of critical goods and PPE needed to combat the virus. Biden also introduced a $700 billion plan to revive the U.S. economy that emphasizes job creation and U.S. manufacturing. Read about these and other updates online here. (Authored by Ivan Zapien)

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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