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Food and Drug Administration (FDA) Genetic Materials

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

Womble Bond Dickinson on

The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more

Womble Bond Dickinson

FDA Updates Guidance on Intentional Genomic Alterations in Animals

Womble Bond Dickinson on

Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more

Womble Bond Dickinson

FDA Issues Guidance for Foods Made from Genome-Edited Plants

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The practice of altering plant genetics to better suit human needs, dates back thousands of years. What was once done through selective plant breeding – as well as alterations beyond what is possible with selective breeding –...more

Knobbe Martens

The FDA Approves Two New Gene Therapies for the Treatment of Sickle Cell Disease

Knobbe Martens on

On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Signals Willingness to Approve CRISPR-Based Treatment for Sickle Cell Anemia

Ever since Watson and Crick ended their seminal Nature paper in 1953 by saying that:  "It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the...more

Goodwin

Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Goodwin on

​​​​​​​Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Emily Chee, the US General Manager of Novartis Gene Therapies, a biotech company specializing in gene therapies for rare...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies: Insights on Coverage, Reimbursement and Emerging Models

Editor’s Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage,...more

MoFo Life Sciences

FDA Finalizes Guidance On Interpretation Of Orphan Drug “Sameness” For Gene Therapy Products

MoFo Life Sciences on

On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more

Morgan Lewis - As Prescribed

FDA Finalizes Guidance on Gene Therapy Orphan Sameness, but Questions Remain

While it may feel like FDA’s attention has been focused on COVID-19 for nearly two years, as we have written about in a previous blog post, FDA is looking to the future, and particularly, one that signals exciting prospects...more

Sheppard Mullin Richter & Hampton LLP

New State Genetic Privacy Law Directed at Consumer Genetic Tests

Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer...more

Proskauer - Minding Your Business

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine....more

Hogan Lovells

Genetic tests and medication response: FDA announces collaborative review of scientific evidence

Hogan Lovells on

FDA announced the introduction of a collaboration between the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) to provide the agency’s view of the current science in...more

Robins Kaplan LLP

Financial Daily Dose 8.7.2019 | Top Story: Novartis Hid Altered Drug Test Data From FDA

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A new report out Tuesday from the Food & Drug Administration reveals that drug maker Novartis “concealed manipulated data” from the agency “while applying for approval of an extremely expensive gene therapy treatment and then...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Cell and gene therapies

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Knobbe Martens

Patenting and regulation of methods for creating three-parent babies

Knobbe Martens on

A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro...more

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

Hogan Lovells

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

Holland & Knight LLP

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

Holland & Knight LLP on

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

Foley & Lardner LLP

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Foley & Lardner LLP on

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more

Mintz - Consumer Product Safety Viewpoints

FDA to Host First Public Meeting on Biotech Regulation Overhaul

On October 15, 2015, the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated...more

BakerHostetler

White House Announces Plans To Revise the Coordinated Framework for the Regulation of Biotechnology

BakerHostetler on

The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic...more

Foley & Lardner LLP

Is Next Generation Sequencing Ready for Personalized Medicine?

Foley & Lardner LLP on

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

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