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Life Sciences Biotechnology Prescription Drugs

Foley & Lardner LLP

GLP-1 Receptor Agonists: The Surge of M&A Activity and the Future of Metabolic Health

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Over the past decade, the global pharmaceutical industry has witnessed a transformation in the treatment landscape for metabolic disorders, particularly type 2 diabetes and obesity. At the heart of this shift is the explosive...more

Goodwin

EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars

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On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more

Morgan Lewis - As Prescribed

FDA's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

Downs Rachlin Martin PLLC

Mass General Brigham study offers promise that nasal spray targeting neuroinflammation could become an effective treatment for TBI

The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult.  There is no clearly...more

Proskauer Rose LLP

Question of the Week: How are expiring patents fueling M&A in the life sciences industry?

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Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our...more

Ropes & Gray LLP

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

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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

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – Q4 2024 – A Quarterly Report on Financing Trends

Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more

Sheppard Mullin Richter & Hampton LLP

New Accelerated Approval Guidance Underscores Need for Accountability

On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more

McDermott Will & Schulte

Key Takeaways | State of the Market – Still Looking for an Exit

During this session, the panelists discussed notable developments within the life sciences industry with a specific focus on the GLP-1 drug market and its opportunities for improvement in patient satisfaction and dosage. They...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

Fenwick & West LLP

Update on the BioSecure Act

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The BioSecure Act is a bipartisan bill introduced in both the U.S. House of Representatives and Senate earlier this year that would effectively stop companies that are doing business with the U.S. government from using...more

Polsinelli

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

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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

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – A Quarterly Report on Financing Trends – Q1 2024

This report series examines quarterly trends in life sciences venture investment. Key findings for Q4 2023 include: • Life sciences VC deal value in Q4 2023 totaled $6.6 billion, representing a 25.0% decrease from the prior...more

White & Case LLP

Oncology dealmaking fuels biotech M&A

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Global spending on cancer medicines is set to reach US$375 billion by 2027, with innovation in drug discovery and development ramping up to meet rising demand. While the global biotech sector continues to grapple with...more

Jones Day

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

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The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – A Quarterly Report on Financing Trends – Q4 2023

This report series examines quarterly trends in life sciences venture investment. Key findings for Q3 2023 include: Life sciences VC deal value in Q3 2023 totaled $7.7 billion, representing an uptick from last quarter...more

Goodwin

Celltrion Expands Access to YUFLYMA (adalimumab-aaty)

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On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA)...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

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Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information

On May 31, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations regarding prescription drug product labeling regulations. Under the new rule, each time a prescription drug products is...more

Hogan Lovells

Advertising of medicinal products in Spain

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The Ministry of Health launches the prior public consultation to update the regulatory framework applicable to the advertising of medicinal products.  Until 1 May 2023, anyone interested in this regulatory initiative may...more

Smart & Biggar

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

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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

Nelson Mullins Riley & Scarborough LLP

Minimizing the Fallout from Increasing FDA Clinical Holds

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

White & Case LLP

PMB performs as pharma groups repurpose their portfolios

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After a year of historic profits in 2021 following the mass roll-out of COVID-19 vaccines and related treatments, big pharma companies armed with cash for deals have been shifting their attention - Overall, pharma, medical...more

Morgan Lewis

Blockbuster Biologics Review | Issue 17

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Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Hogan Lovells

World Stem Cell Summit panel compares global trends in regenerative medicine regulations

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Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more

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