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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

Maynard Nexsen

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

Maynard Nexsen on

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

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

Jones Day

Vital Signs: Digital Health Law Update | Summer 2021

Jones Day on

NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

Morgan Lewis - As Prescribed

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021

Hogan Lovells on

In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 19

Hogan Lovells on

In Washington: President Biden on Thursday doubled to 200 million his administration’s goal for the number of COVID-19 vaccination shots to administer in his first 100 days in office. The U.S. is set to reach Biden’s original...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2021

Hogan Lovells on

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

Hogan Lovells

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

Hogan Lovells on

In Washington: The House Budget Committee approved legislation for a $1.9 trillion coronavirus relief package on Monday evening, with a full House vote is expected at the end of this week. So far, House Democrats expect a...more

Burr & Forman

Health Care E-Note - January 2021

Burr & Forman on

Helpful Hints - ADPH Says Vaccine Administration is Limited at this Time The Alabama Department of Public Health issued a press release on January 11, 2021, urging Alabamians to have patience in receiving the COVID-19...more

Robins Kaplan LLP

Financial Daily Dose 1.25.2021 | Top Story: Merck Abandons Covid Vaccine Effort Over Ineffective Results

Robins Kaplan LLP on

U.S. drug giant Merck is shuttering its coronavirus vaccine development “after early trial data showed [its pair of vaccines] failed to generate immune responses comparable to natural infection or existing vaccines.” ...more

Hogan Lovells

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

Hogan Lovells on

In Washington: President-elect Joe Biden unveiled the first plan to is two-part $1.9 trillion stimulus package calling on Congress to approve $415 billion in emergency spending to scale up vaccinations, testing, and other...more

Kilpatrick

The Lead COVID-19 Vaccine Candidates: Where We Are and What You Should Know

Kilpatrick on

Exciting developments are being reported for COVID-19 vaccine candidates - on a daily basis. There are nearly 200 vaccine candidates, with at least 20 in late-stage clinical trials. Of those, the FDA has approved both the...more

Womble Bond Dickinson

Intranasal vaccines may be more effective alternatives to conventional injections

Womble Bond Dickinson on

Intranasal vaccine may be our best weapon in the battle to obliterate COVID-19 and other potential future pandemics. Animal studies have shown that a more widespread immunity is produced with an intranasal vaccine than an...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 14

Hogan Lovells on

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

Smart & Biggar

Health Canada – COVID-19 update highlights

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Womble Bond Dickinson

An Untapped Natural Treasure Trove of Viruses to Treat Drug-Resistant Bacterial Infections

Womble Bond Dickinson on

Phages, formally called bacteriophages — the most abundant, ubiquitous organisms in nature — are viruses that infect, replicate in, and destroy bacteria. These viruses are species-specific, and sometimes infect only certain...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

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

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

K&L Gates LLP

COVID-19: Frontline University Perspective on the Pandemic’s Disruption to Ongoing Research, and Public Policy Projections for a...

K&L Gates LLP on

In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are...more

Akerman LLP - Health Law Rx

COVID-19 and Possible Silver Bullets: Update on Vaccine Development

As the world continues to grapple with the COVID-19 pandemic that has taken the lives of over 250,000 Americans, and worldwide over 1 million people, this year, an effective vaccine has emerged as our silver bullet – a way...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, November 2020 # 3

Hogan Lovells on

In Washington: The federal government’s role in physically distributing COVID-19 vaccines remains unclear. President Trump said last month that the military would distribute vaccines. But a spokesman for Operation Warp...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 19

Hogan Lovells on

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

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: FDA Guidance on Granting EUAs for a COVID-19 Vaccine

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 17

Hogan Lovells on

In Washington: White House communications director Alyssa Farah said Tuesday that the White House still hopes for a coronavirus relief package, probably post-election. Speaking on Fox & Friends, Farah said President Trump...more

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