News & Analysis as of

Coronavirus/COVID-19 Life Sciences Healthcare

Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms... more +
Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -
ArentFox Schiff

RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development

ArentFox Schiff on

On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more

Dacheng

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

Jones Day

Executive Orders and Policy Updates

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Since President Trump's inauguration, the Trump administration has issued a number of executive orders and policy actions with potential impacts for the life sciences industry. Notable actions include rescinding Biden-era...more

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

McDermott+

DEA Releases Long-Awaited Telehealth Special Registration Proposal, but Adoption Is Uncertain

McDermott+ on

On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations. This proposed rule would establish three...more

Bradley Arant Boult Cummings LLP

Update: Telehealth “Cliff” Looming at End of 2024

As 2024 comes to a close, the telehealth space continues to be uncharted territory. When the COVID-19 pandemic began, the ability to deliver telehealth expanded as providers sought to provide quality care unrestricted by...more

Perkins Coie

BioMaP-Consortium Hosts Inaugural Industry Day

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In previous Updates, we discussed the formation and growth of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), which was started by the Biomedical Advanced Research and Development Authority...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

MoFo Life Sciences

At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, And Distribution Agreements

MoFo Life Sciences on

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

Verrill

Telehealth and the Evolving Landscape of Medicare Requirements

Verrill on

Telehealth is an important and growing part of healthcare delivery that a wide range of patients and healthcare providers have come to rely on for access to care and continuity of treatment. Telehealth took on an especially...more

Ballard Spahr LLP

Key Takeaways From the 2024 J.P. Morgan Healthcare Conference

Ballard Spahr LLP on

Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more

Burr & Forman

Telehealth Prescribing Flexibilities for Controlled Substances Extended Through End of 2024

Burr & Forman on

The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024....more

Sheppard Mullin Richter & Hampton LLP

Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule

This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more

McDermott Will & Schulte

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Knobbe Martens

FDA Updates Medical Device Shortages List

Knobbe Martens on

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2023

This latest issue features an article on Enliven Therapeutics’ reverse merger with Imara and concurrent financing, including an interview with Enliven co-founder and CEO Sam Kintz; a piece on trends in digital health...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 144: Dr. Kashyap Patel - Author & CEO of Carolina Blood...

Maynard Nexsen on

This episode we welcome back our previous guest Dr. Kashyap Patel, a renowned practicing physician, author, and health care thought leader. Dr. Patel discusses spearheading the study of long COVID, his moving experiences with...more

Dickinson Wright

DEA Reverses Course and Extends Telehealth Prescriptions of Controlled Substances

Dickinson Wright on

Reversing previously proposed rules, the DEA recently issued new guidance allowing the continued use of telehealth when prescribing controlled substances following the end of the Covid-19 public health emergency (“PHE”)....more

Robinson & Cole LLP

Health Law Diagnosis - DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

Robinson & Cole LLP on

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more

Polsinelli

DEA Temporary Rule Extends Telemedicine Flexibilities Through November 2023 and Grants Additional One-Year Grace Period

Polsinelli on

Two days ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the  Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule extending...more

Robinson+Cole Health Law Diagnosis

DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 139: Adair Boroughs, U.S. Attorney for the District of...

Maynard Nexsen on

This week Matthew and Heather are excited to welcome the U.S. Attorney for the District of South Carolina, Adair Boroughs! With health care fraud and abuse cases receiving increased funding and attention from the government, ...more

American Conference Institute (ACI)

Tips for Entering the Life Sciences Market in Brazil

For life sciences companies, Brazil’s market offers both an abundance of business opportunities and a myriad of on-the-ground regulatory compliance challenges for new entrants. Getting the market-entry strategy right will...more

White & Case LLP

PMB performs as pharma groups repurpose their portfolios

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After a year of historic profits in 2021 following the mass roll-out of COVID-19 vaccines and related treatments, big pharma companies armed with cash for deals have been shifting their attention - Overall, pharma, medical...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2022

Cornerstone Research reports that during the first six months of 2022, plaintiffs filed 110 securities class actions, a pace that is generally in line — 2.8% higher — with what we saw in the second half of 2021. Looking...more

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