News & Analysis as of

National Institute of Health (NIH) Pharmaceutical Industry Coronavirus/COVID-19

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

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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: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

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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: HHS Selects the First 10 Drugs for Medicare Drug Price Negotiation

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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: Emerging Technology Coverage Pathway, Long COVID Advisory

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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: CMMI Announces Three New Models, President Biden Issues Executive Order

Alston & Bird on

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

Alston & Bird on

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: Congress Passes Omnibus, HHS Releases Hospital Data

Alston & Bird on

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

AEON Law

Patent Poetry: Dispute over COVID Vaccine Shows Importance of Inventorship

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Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...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

Rothwell, Figg, Ernst & Manbeck, P.C.

mRNA Patent and Competitive Landscape: 2021 Year in Review and 2022 Outlook

In April of 2021, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post we provide a 2021 year in review update on mRNA pioneers and key players and offer additional...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...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

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 9

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In Washington: House managers finished presenting their case against former President Trump at his impeachment trial on Thursday. They argued that Trump's statements prior to and at the January 6 "Stop the Steal" rally...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...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

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

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

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From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 7 In This Month's E-News: July 2020

Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more

Bricker Graydon LLP

Clinical research flexibilities during the COVID-19 public health emergency

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Recognizing the significant effects that COVID-19 has had on clinical research, the federal government has issued multiple guidance documents related to clinical research flexibilities to support continued research during the...more

Health Care Compliance Association (HCCA)

From Remote Oversight to Wind-Downs: Research Struggles in the Time of COVID-19

Report on Research Compliance 17, no. 4 (April 2020) - “In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions and to preserve personal protective equipment for...more

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