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Contract Terms Regulatory Requirements Pharmaceutical Industry

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

Goodwin

Five Trends Reshaping Pharmaceutical Manufacturing Partnerships

Goodwin on

How CDMOs are reshaping pharmaceutical partnerships through friendshoring, risk-sharing economics, and specialized development capabilities. The pharmaceutical manufacturing landscape is undergoing a profound shift, with...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Husch Blackwell LLP on

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Hogan Lovells

New development for clinical trial agreements in Germany: Proposal of standard contractual clauses from 21.02.2025

Hogan Lovells on

Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more

Goodwin

Dr. Reddy’s Secures License from Henlius to Market Daratumumab Biosimilar in the U.S. and Europe

Goodwin on

On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s...more

Smith Anderson

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

Smith Anderson on

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

Seyfarth Shaw LLP

Close Was Not Close Enough: First Circuit Denies Executive’s Implied Covenant Claim For Unpaid Equity Compensation Related To A...

Seyfarth Shaw LLP on

Seyfarth Synopsis: On November 27, 2019, the United States Court of Appeals for the First Circuit held that, under Massachusetts law, a terminated employee asserting a claim for being deprived of lost compensation in breach...more

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