News & Analysis as of

Biotechnology Pharmaceutical Industry

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

Gardner Law

Navigating the Biosecure Act: Implications for Biotechnology and Pharmaceutical Companies

Gardner Law on

The Biosecure Act, introduced in January 2024 (H.R. 7085), has garnered significant bipartisan support and is increasingly poised to become law, heightening its impact on the life sciences industry. The bill, now amended to...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James...

Maynard Nexsen on

This week, hosts Matthew and Heather welcome back James Chappell, President and CEO of SCbio, to discuss the organization’s new program, SCbioDrive, an accelerator program for emerging life sciences companies. The group...more

Kilpatrick

7 Key Takeaways - The Federal Circuit's New § 112 Attack on Biotechnology: Diagnosis and Prescription

Kilpatrick on

Kilpatrick attorneys Yifan Mao and Stuart Pollack recently attended the 20th annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) to discuss the “The Federal Circuit’s New § 112 Attack on Biotechnology: Diagnosis...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

McDermott Will & Emery

Key Takeaways | Pharma and MedTech Manufacturing and Contract Development

McDermott Will & Emery on

During the session, the panelists discussed investment strategies in the Contract Development and Manufacturing Organization (CDMO) space, emphasizing factors like supply and demand dynamics, quality control, and the impact...more

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

McDermott Will & Emery on

The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

Polsinelli on

Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

Bergeson & Campbell, P.C.

Biden-Harris Administration Announces Actions to Accelerate U.S. Domestic Biomanufacturing Capacity

The White House Office of Science and Technology Policy (OSTP) published a fact sheet on June 25, 2024, on the Biden-⁠Harris Administration’s actions to advance American biotechnology and biomanufacturing. According to the...more

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

Hogan Lovells on

This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...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

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2024

This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2024 #4

News Briefs - Biden Places New Tariffs on Chinese Medtech Product Imports - The Biden administration announced its plan to increase tariffs on Chinese-made medical supplies as part of a broader push to tax imports from the...more

Orrick, Herrington & Sutcliffe LLP

The EU AI Act: Key Takeaways for Life Sciences and Digital Health Companies

This update is part of our EU AI Act Essentials Series. The European AI Act is a landmark piece of legislation that establishes the first major comprehensive framework for regulating the use of artificial intelligence,...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

BakerHostetler

Updated BIOSECURE Act Scheduled For Committee Vote

BakerHostetler on

A House committee will vote May 15 on an updated version of the BIOSECURE Act, legislation that would block federal contracts to five Chinese biotechnology companies and other drugmakers with certain China-based companies in...more

BakerHostetler

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

BakerHostetler on

In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

Mintz

Doing Life Sciences Deals in 2024

Mintz on

Nearly one hundred life sciences professionals convened at Mintz’s Boston office last week for an event we hosted in partnership with the LES (Licensing Executives Society). I moderated a panel, “Structuring Your Life...more

Latham & Watkins LLP

Healthcare and Life Sciences Trends and Developments Across MENA

Latham & Watkins LLP on

The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are...more

McDermott Will & Emery

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

McDermott Will & Emery on

YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Foley Hoag LLP

Healthcare Issues to Watch Following the FY2024 Spending Deal

Foley Hoag LLP on

Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...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

Axinn, Veltrop & Harkrider LLP

Puma and the Pitfalls of the “Narrow” Exclusive License

8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...more

631 Results
 / 
View per page
Page: of 26

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide