Popular, Biotechnology, Pharmaceutical Industry

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

Rothwell, Figg, Ernst & Manbeck, P.C. on 7/24/2025

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on 5/21/2025

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Life Sciences Under the Microscope: Key 2024 Takeaways and What’s Ahead for 2025

Ropes & Gray LLP on 2/28/2025

The life sciences industry experienced a dynamic year in 2024. As the public markets gained traction, IPO activity and venture investment saw a resurgence, signaling renewed investor confidence and reflecting sustained...more

Life Sciences M&A Trends for 2023 and 2024 (Through End of Q3) in Greater China

Goodwin on 11/11/2024

Goodwin is presenting a two-part publication series covering life sciences trends involving license deals, M&A, and financing for Greater China’s life sciences sector. ...more

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

Hogan Lovells on 6/28/2024

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

The Life Sciences Report – June 2024

Wilson Sonsini Goodrich & Rosati on 6/11/2024

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

Updated BIOSECURE Act Scheduled For Committee Vote

BakerHostetler on 5/14/2024

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

Healthcare and Life Sciences Trends and Developments Across MENA

Latham & Watkins LLP on 4/19/2024

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

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

Lowenstein Sandler LLP on 3/19/2024

The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

The BIOSECURE Act and Its Potential Implications

Goodwin on 3/6/2024

Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more

In the Wake of the Supreme Court's Amgen v. Sanofi decision: What’s Next for Biotechnology Claims?

McDonnell Boehnen Hulbert & Berghoff LLP on 10/3/2023

Section 112 of the patent statute, which in earlier years was something of a backwater in patent law, has had a tumultuous quarter century beginning with the Federal Circuit decision in Regents of the University of California...more

Transatlantic M&A bull run set for comeback

White & Case LLP on 9/15/2023

Encouraged by the relative strength of the dollar and improving financing conditions, US bidders are snapping up European assets - Transatlantic M&A was enjoying record-high activity before the war in Ukraine sparked...more

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

Morgan Lewis on 6/6/2023

China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

Procopio, Cory, Hargreaves & Savitch LLP on 5/23/2023

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more

Supreme Court Renders Decision in Amgen v. Sanofi: Three Takeaways

McDonnell Boehnen Hulbert & Berghoff LLP on 5/19/2023

The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more

Antitrust & Competition Life Sciences 2022 Year In Review

Goodwin on 2/22/2023

M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership...more

Global healthcare M&A delivers strong performance

White & Case LLP on 1/25/2023

Dealmaking in the pharma, medical and biotech (PMB) subsectors was driven by both old and new market trends in 2022 - Following a ground-breaking year for dealmaking in 2021, global healthcare M&A remained robust in 2022,...more

Decoded - Technology Law Insights, Issue 23, 2022

Spilman Thomas & Battle, PLLC on 12/5/2022

Complex, Customized CRISPR Combo Could Help Patients Cure Their Own Cancer - “In a small phase 1 clinical trial run by PACT Pharma, researchers edited the genes of 16 patients’ immune cells to work against their cancer,...more

President Biden Signs Executive Order on Biotechnology and Biomanufacturing Innovations

McDonnell Boehnen Hulbert & Berghoff LLP on 9/15/2022

On Monday, September 12th, President Biden signed an Executive Order entitled "Advancing Biotechnology and Biomanufacturing Innovation for Sustainable, Safe and Secure American Bioeconomy." The Executive Order (in Section...more

Gene therapy development in Europe brings layers of liability risks

Hogan Lovells on 7/14/2022

The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...more

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

American Conference Institute (ACI) on 6/21/2022

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

2021 Popular Content Among Biotech Readers on JD Supra

Beacon Insights by JD Supra on 12/10/2021

A look at what interested readers from the biotech space most on JD Supra during 2021....more

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

American Conference Institute (ACI) on 9/14/2021

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

AI in Biotech and Synthetic Biology: What Can Be Protected? What Should Be Kept Secret?

Mintz - Intellectual Property Viewpoints on 8/11/2021

Machine learning (ML), bioinformatics, artificial intelligence (AI), and other computational tools have become ubiquitous in the biotech and synthetic biology industries because such technology allows for rapid processing of...more

Key Steps The Pharma And Bioscience Sectors Must Take Ahead Of Federal Scrutiny Of COVID-19 Relief Funding

Fox Rothschild LLP on 11/24/2020

An unprecedented explosion of government investigation and enforcement is at hand as federal regulators focus their efforts on ferreting out any fraud or abuse of the $1 trillion in COVID-19 relief funding programs through...more

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