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Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

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As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Goodwin

Allergan Files ITC Complaint Against Evolus to Block Imports of Newly Approved Botox Follow-On

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On January 30, 2019, Allergan and its partner Medytox filed a complaint with the ITC to block imports of Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection) product, DWP-450, manufactured by...more

Saul Ewing LLP

Navigating Five Key Legal and Regulatory Hurdles to Get and Keep Your Product on the Market

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Food and beverage, drug, medical device, cosmetics, and consumer products companies must navigate a maze of legal and regulatory challenges in order to get and keep their products on the market — from concept, to development,...more

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

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As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Patterson Belknap Webb & Tyler LLP

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

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