News & Analysis as of

Biotechnology Food and Drug Administration (FDA)

Faegre Drinker Biddle & Reath LLP

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

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

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Napoli Shkolnik

The Risks of Unregulated Regenerative Medicine

Napoli Shkolnik on

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

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Perkins Coie

USDA APHIS Invites Stakeholder Comments on Regulation of Modified Microbes

Perkins Coie on

In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the...more

ArentFox Schiff

USDA’s Biotechnology Regulator Issues Much-Anticipated RFI on Regulation of Modified Microbes

ArentFox Schiff on

On July 2, the US Department of Agriculture (USDA) Animal and Health Inspection Service (APHIS) published a Request for Information (RFI) seeking public comment on the improvement of regulatory processes governing genetically...more

Knobbe Martens

Boston Scientific Agrees to Acquire Silk Road Medical in $1.16B Deal

Knobbe Martens on

Press releases report that Boston Scientific (BSX) has entered an agreement to acquire medical device developer Silk Road Medical in a deal totaling $1.16 billion. Silk Road Medical has reportedly developed devices and...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, May 2024

TSCA/FIFRA/TRI - EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk To Human Health: On April 16, 2024, the U.S. Environmental Protection Agency (EPA) announced...more

Bergeson & Campbell, P.C.

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and...more

Goodwin

Amgen and Sandoz Settle Denosumab BPCIA Litigation

Goodwin on

As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab...more

Beveridge & Diamond PC

EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks

Beveridge & Diamond PC on

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in...more

Bergeson & Campbell, P.C.

CRS Publishes Report on Regulation of Gene-Edited Plants and Issues for Congress

The Congressional Research Service (CRS) published a report on March 22, 2024, on “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation...more

Knobbe Martens

USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources

Knobbe Martens on

On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

Knobbe Martens on

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Morrison & Foerster LLP

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more

Venable LLP

Celltrion Submits an aBLA for Actemra® (tocilizumab) Proposed Biosimilar CT-P47

Venable LLP on

On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...more

MoFo Life Sciences

New Regulations Rooted In Evidence: Looking Back On How EPA And USDA Updated Engineered Plant Regulations And Labeling In 2023

MoFo Life Sciences on

Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year....more

Fenwick & West LLP

Reflections on the J.P. Morgan Healthcare Conference: Key Themes for 2024

Fenwick & West LLP on

The Fenwick life sciences team recently returned from the 2024 JP Morgan Healthcare conference. As we reflect back on the week, there were several key themes and trends that we expect will continue to resonate and evolve over...more

Morrison & Foerster LLP

Comment on Morphing U.S. Biotechnology Regulations

Morrison & Foerster LLP on

The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren welcome Dr. Ehsan Samei and Dr. Susan Halabi, leaders of the new Triangle CERSI, which stands for the Center of Excellence in Regulatory...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

Foley & Lardner LLP

Strengthening the Flow of the Biotech Sector’s M&A Pipeline

Foley & Lardner LLP on

Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...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

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

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