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Regulatory Requirements Biotechnology Pharmaceutical Industry

Goodwin

Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)

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On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more

Rothwell, Figg, Ernst & Manbeck, P.C.

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

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

A&O Shearman

A new European strategy to foster life sciences innovation and market access

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On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

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The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

A&O Shearman

Creative deal structures help life sciences innovators ride out the macro storm

A&O Shearman on

Globally, market volatility has eroded confidence and subdued M&A activity. A “wait and see” approach is the prevailing sentiment for many market participants; it is difficult to convince boards to advance deals while...more

MoFo Life Sciences

What Makes a Good Cell and Gene Therapy Application?

MoFo Life Sciences on

Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Troutman Pepper Locke

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

Troutman Pepper Locke on

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

McDermott Will & Emery

Investment Opportunities in TechBio and Pharma Services - European Health & Life Sciences Symposium 2025

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In April 2025, McDermott once again hosted its 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

Hogan Lovells

FDA animal testing phaseout urges AI-based trial alternatives, organoids, other “NAMs”

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more

McDermott Will & Emery

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

Paul Hastings LLP

Navigating Current Challenges in Biotech M&A

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The biotech mergers and acquisitions market faces significant headwinds in the first half of 2025. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug Administration (FDA) and...more

Goodwin

FDA to Phase Out Animal Testing for Monoclonal Antibodies and other Drugs

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On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

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The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Morgan Lewis

M&A Considerations Across the Evolving Life Sciences Sector: Key Takeaways

Morgan Lewis on

In the latest installment of the Morgan Lewis M&A Academy, partners Laurie Burlingame and Luciana Griebel provided an overview of current market trends in mergers and acquisitions (M&A) and strategic partnerships within the...more

Goodwin

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

Goodwin on

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

Paul Hastings LLP

FDA Funding Changes Could Impact Biotech M&A

Paul Hastings LLP on

With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more

Smith Anderson

Biotech Licensing Caselaw Update - 2024 Year in (Brief) Review

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Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more

Ropes & Gray LLP

Adapting to the IRA: Early Lessons Learned on the IRA’s Impact on Deal-Making, Drug Economics, and Business Strategy

Ropes & Gray LLP on

More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more

Latham & Watkins LLP

Healthcare and Life Science Deals Attorneys Expect In 2025

Latham & Watkins LLP on

As the healthcare industry heads into 2025, deals attorneys are optimistic as they look to falling interest rates and a potentially more business-friendly administration set to enter the White House. Originally published...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

McDermott Will & Emery

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

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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

Gardner Law

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

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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

Smart & Biggar

Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada

Smart & Biggar on

Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more

McDermott Will & Emery

[Webinar] Contracting in Biotech and Pharmaceutical Manufacturing - March 31st, 2:30 pm - 3:30 pm CET

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Companies frequently encounter challenges in the manufacture and supply of their innovative products, in particular with respect to process development and production capacity. In our latest webinar, we review how key...more

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