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National Institute of Health (NIH) Vaccinations Food and Drug Administration (FDA)

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: State of the Union and HHS Guidance on Drug Rebates and PHE

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Weintraub Tobin

From Saving the World to Fighting Over IP: Moderna and Pfizer/BioNTech

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One of the most amazing accomplishments in the field of biotechnology has been the development and distribution of a vaccine against SARS-CoV-2 (COVID 19). The numbers tell the story. The time from when the coronavirus’...more

Alston & Bird

Health Care Week in Review: FDA Released Its User Fee Amendments For FY 2023

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #2

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #4

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

ArentFox Schiff

New Single-Dose Antibody Injection Effective at Preventing Both Initial COVID-19 Infections and Disease Progression in High-Risk...

ArentFox Schiff on

On November 18, 2021, just a few days before the Omicron variant suddenly revealed itself to the world, the preliminary results of two Phase III clinical trials were announced by AstraZeneca, bringing new hope to high-risk...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies - November 2021

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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 this week's Report: U.S....more

Alston & Bird

Alston & Bird Health Care Week in Review - September 2021 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Health Care Week in Review - September 2021 #2

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 4

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In Washington: The Consumer Financial Protection Bureau (CFPB) on Monday proposed a rule ordering debt collectors to inform tenants about their rights under a federal eviction ban if they’ve been unable to pay rent during the...more

Jackson Lewis P.C.

COVID-19 Vaccination: Setting Up On-Site Programs

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The Biden administration has called for all people at least 18 to be eligible for the COVID-19 vaccine by April 19, 2021. Most states have already done so. A BenefitsPro article cites a 2017 survey from the Society for...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 16

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In Washington: On Friday, President Biden pushed Congress to act urgently on his proposed COVID-19 relief package as the White House scraps to garner bipartisan support. "[T]his is a time to act now,” Biden said during a...more

Holland & Knight LLP

COVID-19 Vaccines: Development, Distribution and Dosing

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The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 9

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In Washington: President Trump said Thursday that he is willing to go higher than his current $1.8 trillion offer for the next coronavirus stimulus package as negotiations continue. “Go big or go home,” Trump told Fox...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

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On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 #1

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In Washington - White House Chief of Staff Mark Meadows on Tuesday said that there has been “real progress” in talks with congressional Democrats and Republicans on coronavirus relief legislation. ...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – August 2020 #2

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In Washington - Senate Majority Leader Mitch McConnell (R-KY) is planning to hold floor votes on unemployment benefits forcing Democrats to go on the record as coronavirus relief bill talks stall. Floor votes are a...more

Obermayer Rebmann Maxwell & Hippel LLP

The Race to Create a COVID-19 Vaccine: Acceleration and Collaboration

From the very outset of the COVID-19 pandemic the development of an effective and safe vaccine for COVID-19 became a public and private priority pursed with urgency and intensity. Towards that end, the United States...more

Foley Hoag LLP

FDA Issues New Guidance to Developers of COVID-19 Vaccines

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On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more

King & Spalding

Accelerated Covid-19 Vaccine Clinical Trials

King & Spalding on

Liability exposure and shields for vaccine developers - As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

McGuireWoods LLP

Washington Healthcare Update

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On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

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