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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

McDermott Will & Schulte

European Health & Life Sciences Symposium 2025: Key Takeaways

In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Morgan Lewis - As Prescribed

FDA's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

Holland & Knight LLP

FDA Announces Plan to Phase Out Animal Testing Requirement

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The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more

Latham & Watkins LLP

Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook

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Stakeholders from across the healthcare and biopharmaceutical industry recently convened in San Francisco for the annual J.P. Morgan Healthcare Conference. In this episode of our Connected With Latham podcast series,...more

Foley & Lardner LLP

Unlocking the Future of Medicine: The Role of AI in Drug Discovery

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Since 1995, Nature Medicine has been chronicling advances in medical technology and health care. To mark the journal’s 30th anniversary, each month an issue of critical importance for the future of medicine will be...more

Fenwick & West LLP

Some AI-Discovered Drugs Carry More IP Risks Than Others - Here's Why

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AI is poised to revolutionize drug discovery, but uncertainty in developing protectable IP in this emerging field creates a host of potential risks for companies innovating in this space. Further complicating things: not all...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Hogan Lovells

FDA permits pre-approval for changes to AI devices via Predetermined Change Control Plans

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Ed Hernandez, who oversees drug product manufacturing at Eli Lilly, an international pharmaceutical company. Ed discusses how Eli Lilly...more

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

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For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with...

Maynard Nexsen on

This week, Heather and Lauren welcome Kimberlee Steele, the Managing Director for North America of SHL Medical, a world leader in the design, development, and manufacture of autoinjectors, pen injectors, and drug delivery...more

McDermott Will & Schulte

Key Takeaways | Pharma and MedTech Services Market Overview With McKinsey & Company

During this session, McDermott Partner Kristian Werling and Jeff Smith, a senior partner at McKinsey & Company, shared insights across the pharma and MedTech services industries, including key trends and opportunities shaping...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

Robinson+Cole Data Privacy + Security Insider

HHS Addresses the Growing Influence of Artificial Intelligence in Health Care

Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform­ its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions,...more

Akin Gump Strauss Hauer & Feld LLP

Tech Transfer in the WTO—What’s in It for Africa? And for the Rest of the World?

The “African Group” in the World Trade Organization (WTO) is pushing for discussions—and potentially renegotiation of international trading rules—on how developing countries do and can acquire technology to build resilience...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

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Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

Wilson Sonsini Goodrich & Rosati

2022 Technology and Life Sciences IPO Report

In this issue of the 2022 Technology and Life Sciences IPO Report, we present analysis related to 10 initial public offerings (IPOs), valued at over $75 million, completed by U.S.-based technology and life sciences companies...more

Fenwick & West Life Sciences Group

Big Tech Continues Foray Into Healthcare, Opening New Opportunities for Digital Health Startups

As the financial markets continue to struggle, digital health companies are conserving resources, slowing hiring and minding their burn rate given the uncertainty around the current economic slowdown and whether the economy...more

Knobbe Martens

Osteoconductive Filament Developed for 3D Printed Implants

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Evonik is a specialty chemical company developing biomaterials that serve as metal-free alternatives to traditional bone implants. Evonik’s VESTAKEEP product line includes an osteoconductive polyether ether ketone (PEEK) – a...more

Proskauer - The Patent Playbook

Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”

In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s...more

Knobbe Martens

NeoChord Announces Successful Completion of First-in-Human Procedure with its Mitral Chordal Repair Technology

Knobbe Martens on

NeoChord, Inc. (“NeoChord”) announced on October 4, 2021 that it successfully completed a first-in-human procedure with the NeXuS Transcatheter Mitral Chordal Repair (TMVr) device NeoChord is developing. NeoChord also...more

Fenwick & West Life Sciences Group

Rock Health Summit Brings Together Brightest Minds in Digital Health

In the technology sector, entrepreneurs are often told to “move fast and break things.” But breaking things is something that won’t work in healthcare, so, as an alternative, innovators may consider “moving fast and keeping...more

Proskauer - The Patent Playbook

Update on Artificial Intelligence: Court Rules that AI Cannot Qualify As “Inventor”

Striking a blow to patent applicants seeking to assert inventorship by artificial intelligence (“AI”) systems, the U.S. District Court for the Eastern District of Virginia ruled on September 3, 2021 that an AI machine cannot...more

Proskauer - The Patent Playbook

Artificial Intelligence as the Inventor of Life Sciences Patents?

The question whether an artificial intelligence (“AI”) system can be named as an inventor in a patent application has obvious implications for the life science community, where AI’s presence is now well established and...more

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