In Washington:
With only hours to spare, House and Senate lawmakers were forced to pass a last-minute short-term extension of government funding (H.J. Res. 107) to stave off a government shutdown while congressional...more
12/21/2020
/ 401k ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Federal Funding ,
Financial Stimulus ,
Hospitals ,
Infections ,
Infectious Diseases ,
Johnson & Johnson ,
Legislative Agendas ,
Life Sciences ,
Moderna Inc. ,
Relief Measures ,
Vaccinations ,
Withdrawal Liability
Tuesday, 15 December 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....more
In Washington:
The Senate passed a one-week stopgap bill on Friday, hours ahead of a government shutdown deadline. The bill passed on a voice vote and moved the funding deadline to December 18. The continuing resolution...more
12/14/2020
/ Biogen Idec ,
Business Closures ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Federal Funding ,
Government Shutdown ,
Infections ,
Legislative Agendas ,
Life Sciences ,
Pfizer ,
Pharmacies ,
Relief Measures ,
Restaurant Industry ,
Vaccinations ,
Walgreens
In Washington:
POLITICO reporter Burgess Everett tweeted that Senate Majority Leader Mitch McConnell (R-KY) says “negotiators should drop both state and local aid and liability shield provisions in order to reach consensus...more
12/9/2020
/ Biden Administration ,
Coronavirus/COVID-19 ,
Dear Colleague Letter ,
Florida ,
Food and Drug Administration (FDA) ,
Food Service Workers ,
Government Shutdown ,
Hackers ,
Immunity ,
Infections ,
Infectious Diseases ,
Legislative Agendas ,
Liability ,
Life Sciences ,
Masks ,
Pfizer ,
Vaccinations
In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more
12/8/2020
/ Administrative Appointments ,
Biden Administration ,
Coronavirus/COVID-19 ,
Dr. Anthony Fauci ,
EU ,
European Commission ,
Infections ,
Infectious Diseases ,
Life Sciences ,
Medical Supplies ,
Pfizer ,
Pharmaceutical Industry ,
Public Health Emergency ,
Regulatory Agenda ,
Vaccinations
In Washington:
President-elect Joe Biden picked California Attorney General Xavier Becerra to be his health secretary. Becerra was a defender of the Affordable Care Act. Separately, Biden picked a Harvard infectious...more
12/8/2020
/ Administrative Appointments ,
Biden Administration ,
Colleges ,
Coronavirus/COVID-19 ,
Dr. Anthony Fauci ,
FDA Approval ,
Financial Stimulus ,
Government Investigations ,
Government Shutdown ,
Infections ,
Infectious Diseases ,
Kodak ,
Layoffs ,
Life Sciences ,
Mental Health ,
Moderna Inc. ,
National Institute of Health (NIH) ,
Navajo Nation ,
Occupational Exposure ,
Operation Warp Speed ,
Pfizer ,
Public Health Emergency ,
Relief Measures ,
Trump Administration ,
Workplace Safety
In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...more
12/1/2020
/ Biden Administration ,
Biotechnology ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Foreign Direct Investment ,
Hong Kong ,
Infections ,
Infectious Diseases ,
Insolvency ,
Joint Task Force ,
Life Sciences ,
Moderna Inc. ,
Pharmaceutical Industry ,
Scams ,
Spain ,
Vaccinations
On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars...more
12/1/2020
/ Affordable Care Act ,
Biden Administration ,
Biotechnology ,
China ,
Coronavirus/COVID-19 ,
Drug Pricing ,
FDA Approval ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Operation Warp Speed ,
Presidential Elections ,
Trans-Pacific Partnership ,
US Trade Policies ,
Vaccinations
Tuesday, 24 November 2020 -
U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Pricing ,
FDA Approval ,
Healthcare Reform ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Life Sciences ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Most-Favored Nations ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Vaccinations
In Tuesday's Report: Moderna announces vaccine efficacy, Fauci concerned about presidential transition, testing labs raise supply chain alarm, impact of COVID-19 on insolvency and arbitration in the U.K., and a podcast on...more
11/17/2020
/ Arbitration ,
Biden Administration ,
Coronavirus/COVID-19 ,
Dr. Anthony Fauci ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Insolvency ,
Life Sciences ,
Masks ,
Moderna Inc. ,
Public Health Emergency ,
Supply Chain ,
UK ,
Vaccinations
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...more
Life Sciences and Health Care Horizons virtual event series -
The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more
11/9/2020
/ Affordable Care Act ,
Business Disruption ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Emergency Use Authorization (EUA) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Imports ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Presidential Elections ,
Public Health ,
Supply Chain ,
Trade Relations ,
Webinars
In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more
In Washington:
House Speaker Nancy Pelosi (D-CA) in a Thursday morning letter to Treasury Secretary Steven Mnuchin pressed the White House for a response to the Democrats' latest coronavirus relief package proposal....more
10/30/2020
/ American Express ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Dr. Anthony Fauci ,
Exxon Mobil ,
Financial Stimulus ,
GDP ,
Housing Market ,
Infectious Diseases ,
Joint Task Force ,
Layoffs ,
Legislative Agendas ,
Life Sciences ,
Masks ,
MasterCard ,
Profits ,
Proposed Legislation ,
Regeneron ,
Regulatory Mandates ,
Relief Measures ,
Trump Administration ,
Vaccinations ,
Visa Inc
In Tuesday's Report: FDA warns over drug misbranded as COVID-19 treatment; podcast discusses Trump's "Buy American" executive order; an op-ed on the importance of protecting biomedical innovation; HHS sees high level...more
10/26/2020
/ Biopharmaceutical ,
Buy America ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Life Sciences ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Trump Administration
Tuesday, 20 October 2020 -
President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for...more
10/20/2020
/ CDRH ,
Coronavirus/COVID-19 ,
Dr. Anthony Fauci ,
Emergency Use Authorization (EUA) ,
Executive Orders ,
Financial Stimulus ,
Food and Drug Administration (FDA) ,
Government Lockdown ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Relief Measures ,
Supply Chain ,
Trump Administration
In Washington:
Hopes for a quick resolution to the stimulus talks continue to fade though House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin continue talking this week to try and bridge the gap between...more
10/14/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Donald Trump ,
Dr. Anthony Fauci ,
Dropbox ,
Eli Lilly ,
Facebook ,
Financial Distress ,
Financial Stimulus ,
Infectious Diseases ,
Johnson & Johnson ,
Legislative Agendas ,
Life Sciences ,
Movie Theaters ,
Nancy Pelosi ,
National Institute of Allergy and Infectious Diseases (NIAID) ,
Paycheck Protection Program (PPP) ,
Relief Measures ,
Remote Working ,
Secretary of the Treasury ,
Trump Administration ,
Vaccinations ,
Virus Testing
Tuesday, 13 October 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. President Trump and his aides on Friday...more
10/13/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Financial Stimulus ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Medicaid Reimbursements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Relief Measures ,
Trump Administration ,
Vaccinations
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.
...more
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.
...more
9/29/2020
/ CDRH ,
Centers for Disease Control and Prevention (CDC) ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Reform ,
Trump Administration ,
Virus Testing
In Tuesday's Report: Germany clarifies restrictions on dispensing in-vitro diagnostic kits, UK partners with Valneva on vaccine production, U.S. CDC reverts to older guidance, HHS bars health agencies from signing new rules,...more
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: FDA...more
9/15/2020
/ Adverse Events ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Reporting Requirements
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.
...more
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....more
8/26/2020
/ Biologics ,
China ,
Coronavirus/COVID-19 ,
Debt Financing ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
EU ,
Food and Drug Administration (FDA) ,
Inspections ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Moratorium ,
Payment Systems ,
Pharmaceutical Industry ,
Relief Measures
In Tuesday's report: FDA issues first EUA for sample pooling, closes its COVID-19 hotline, and extends HCT/P enforcement discretion; a litigation team podcast on work return risks; Virginia establishes COVID-19 workplace...more