News & Analysis as of

Biotechnology › Research and Development › Medical Research

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with...

Maynard Nexsen on

Ming-Wei Chen and Fanheng Zhou, the scientists behind RephImmune, join hosts Lynnsey and Matthew to discuss how their biotech startup is developing a next-generation cell therapy platform designed to overcome the limitations...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

Fenwick & West LLP on

As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Faegre Drinker Biddle & Reath LLP

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

Faegre Drinker Biddle & Reath LLP on

On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more

Maynard Nexsen

Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist

Maynard Nexsen on

Recorded at SCbio’s 2024 annual conference, hosts Heather and Matthew welcome Sarah Glaven, a research biologist and the Assistant Director of Biotechnology and Biomanufacturing for The White House Office of Science and...more

Morgan Lewis - As Prescribed

Executive Order Outlines New Federal Biotechnology/Manufacturing Goals

Morgan Lewis - As Prescribed on

President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this EO, the president aims to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Epigenetic Changes Implicated in Age-related Diminution in Vision and Its Possible Reversal

McDonnell Boehnen Hulbert & Berghoff LLP on

The Fountain of Youth -- an enduring aspiration, particularly as the ravages of age reduce human faculties prior to leading inexorably to death.  Reduction in sight is the human faculty that can have the greatest effect on...more

White & Case LLP

New expansion of foreign direct investments control regime in France and the impact on French biotech companies

White & Case LLP on

White & Case Technology Newsflash - In line with the increased protectionism around foreign direct investments (FDI) in the past few years, the economic impact of COVID-19 led to a worldwide rapid expansion of existing...more

Herbert Smith Freehills Kramer

A Therapeutic Solution for COVID-19: Repurposing Existing Drugs

Herbert Smith Freehills Kramer on

For decades, antiviral drugs have been used to combat viral infections, including HIV/AIDS and influenza. Now they are a source of hope in the fight against the COVID-19 pandemic....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

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