News & Analysis as of

Regenerative Medicine

Knobbe Martens

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease...

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On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more

Napoli Shkolnik

The Risks of Unregulated Regenerative Medicine

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A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more

Hogan Lovells

O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

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Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more

Hogan Lovells

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

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Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a biologics license application (BLA) with...more

Hogan Lovells

CMS proposes sweeping changes to regenerative medicine reimbursement framework

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Last month, the Centers for Medicare & Medicaid Services (CMS) released new and significant proposals impacting Medicare coding, coverage, and reimbursement for a class of regenerative medicines known as “skin substitutes,” a...more

Hogan Lovells

World Stem Cell Summit panel compares global trends in regenerative medicine regulations

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Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more

Hogan Lovells

World Stem Cell Summit panel cautions over stepped up HCT/P enforcement, reimbursement issues

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Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more

Hogan Lovells

FDA invites comments on xenotransplantation product regulatory standards ahead of public meeting

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On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss its regulatory expectations for...more

Hogan Lovells

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

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On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

Morgan Lewis - As Prescribed

FDA Talks Regenerative Medicine Advanced Therapy Designation

At the Food and Drug Law Institute’s 2021 annual conference, Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, commented on progress that has been made using FDA’s Regenerative Medicine...more

Hogan Lovells

Time’s up: New enforcement era for regenerative medicines begins June 1 - CBER reiterates May 31 end for HCT/P compliance “grace...

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On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they...more

Bradley Arant Boult Cummings LLP

The Government’s Watchful Eye on Fraud Stemming from Stem Cell Therapy

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more

Smart & Biggar

New CADTH Report on Health Technology Trends in 2021

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The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...more

Dunlap Bennett & Ludwig PLLC

The Transgenic Mice of Regeneron

At a recent campaign stop, President Trump informed supporters that he “felt like Superman” after his experimental COVID-19 treatment with a Regeneron Pharmaceuticals Inc. antiviral drug. The antiviral drug may have resulted...more

Wilson Sonsini Goodrich & Rosati

FDA Delays Regulatory Enforcement of Stem Cells, Other Cellular and Tissue Products

In a move welcomed by industry, the Food and Drug Administration (FDA) has granted six additional months of enforcement discretion to manufacturers of certain human cell, tissue, or cellular or tissue-based products (HCT/Ps)....more

Epstein Becker & Green

In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review

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On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more

Mintz - Health Care Viewpoints

Further Update on FDA’s Comprehensive Regenerative Medicine Framework: November 2020 Deadline Extended by Six Months

About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not...more

Smart & Biggar

COVID-19 developments – federal government issues request for information for alternative suppliers for certain pharmaceuticals

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The federal government has been proactive in seeking help from industry in tackling the pandemic. For example, Health Canada contacted Health Product Licence Holders to let them know specific areas where they may be able to...more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

Mintz - Health Care Viewpoints

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more

Wilson Sonsini Goodrich & Rosati

A Preliminary Evaluation of the RMAT Designation's Effect on Publicly Traded Company Stock Price

The 21st Century Cures Act created the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative medical therapies. An RMAT designation conveys significant regulatory...more

Hogan Lovells

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

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Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist...more

Wilson Sonsini Goodrich & Rosati

The Regenerative Medicine Advanced Therapy (RMAT) Designation and Its Importance to New Product Development

The 21st Century Cures Act enacted the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative therapies. Qualifying for RMAT designation conveys significant...more

Hogan Lovells

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

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On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more

Hogan Lovells

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

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Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

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