News & Analysis as of

Life Sciences › Research and Development › FDA Approval

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

Troutman Pepper Locke on

With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Stotler Hayes Group, LLC

6 Things LTC Providers Need to Know About the COVID-19 Vaccine on the Cusp of Its US Approval

Stotler Hayes Group, LLC on

Since COVID-19 strong-armed its way to the forefront of the US media in March 2020, we’ve seen hundreds, even thousands of news stories, opinion pieces, and agency reports on related topics ranging from its impact on schools...more

Hogan Lovells

Looking ahead to 2021: AI – A brave new world?

Hogan Lovells on

In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more

Morgan Lewis

COVID-19 Vaccine: Considerations for UK Employers

Morgan Lewis on

The eagerly anticipated news of coronavirus (COVID-19) vaccine candidates last week has been welcomed by the scientific community across the globe. For employers, the news has prompted consideration of the potential...more

Seyfarth Shaw LLP

FDA Approves Veklury (remdesivir) As The First Treatment For COVID-19

Seyfarth Shaw LLP on

On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19....more

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

Morgan Lewis on

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

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

Morgan Lewis on

The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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