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Biotechnology › Research and Development › Biologics

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

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

Goodwin

White House Announces “Bold Goals” for Biotech

Goodwin on

In a report entitled “Bold Goals for U.S. Biotechnology and Biomanufacturing,” the White House recently announced several biotech-related “bold goals” to advance the environmental, agricultural, economic, health, and science...more

Hogan Lovells

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

Hogan Lovells on

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser (transcript)

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...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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