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Life Sciences Infectious Diseases

Perkins Coie

BARDA BioMaP-Consortium Up and Running

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In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

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The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

Smart & Biggar

Minister of Health announces National Strategy for Drugs for Rare Diseases

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On March 22, 2023, the Minister of Health announced the first-ever National Strategy for Drugs for Rare Diseases. This strategy includes $1.5 billion invested to “increase access to, and affordability of, effective drugs for...more

Akin Gump Strauss Hauer & Feld LLP

USITC Sets Out Process of Its Investigation into TRIPS Waiver Expansion

On February 1, the USITC formally announced the opening of its investigation into the merits of expanding the TRIPS Waiver to diagnostics and treatments. The investigation was initially requested by USTR, who had been leading...more

Epstein Becker & Green

COVID-19 Vaccination and the Fetal Cell Line Conundrum for Employee Religious Objections

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The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more

Robinson & Cole LLP

Clinical ColLABorative - Legal Insights in Laboratory Compliance

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What To Do When The Government Knocks On Your Lab’s Door - The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more

Knobbe Martens

U.S. FDA Approves Monkeypox Treatment Formulation

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(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...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

McDonnell Boehnen Hulbert & Berghoff LLP

IP Associations "Concerned" by Reports of TRIPS Waiver Compromise

Earlier today, the American Intellectual Property Law Association (AIPLA), Intellectual Property Owners Association (IPO), Licensing Executives Society (LES) International, LES USA & Canada, and New York Intellectual Property...more

McDonnell Boehnen Hulbert & Berghoff LLP

More on Leaked WTO COVID-19 Vaccine Patent Waiver Compromise

A Reuters report published last week indicated that the United States, European Union, India, and South Africa had reached an agreement on a waiver with respect to patents for COVID-19 vaccines.  The text of the compromise...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies - March 2022

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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: FDA warns...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: New Guidance on Measuring Severity Anticipated

As vaccination rates drop to an all-time low in the United States, the CDC is preparing new guidance on measuring the severity of outbreaks in our communities. Meanwhile, a study on the impact of hospitalization on the mental...more

Robinson+Cole Health Law Diagnosis

COVID-19 Vaccine Update – February 2022

The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more

Knobbe Martens

FDA Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19

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In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies - January 2022

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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: Woodcock...more

A&O Shearman

COVID-19 – the distinction between vaccines and vaccination

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Vaccines - With thanks to a huge global scientific effort, we now have several COVID-19 vaccines that are safe and effective. - ...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

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In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sen. Tillis Writes to U.S. Trade Representative (Again) Regarding TRIPS Waiver

Earlier this month, Sen. Thom Tillis (R-NC), the Ranking Member of the Subcommittee on Intellectual Property of the Senate Committee of the Judiciary, wrote to United States Trade Representative Katherine C. Tai to express...more

Maynard Nexsen

The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?

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Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Booster Shots Get FDA, CDC Greenlight

Major developments in vaccine authorizations and mandates continue in the U.S., while the surge in Europe has prompted one country to implement a lockdown — and also declare a national vaccine mandate. mRNA COVID-19...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Vaccine Approved for Children, OSHA Vaccination Mandate

Efforts to continue to promote and expand access to COVID-19 vaccines reached major milestones this week, as the holiday season draws near. OSHA Vaccination Mandate - In early September, President Biden released a...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

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