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New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
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M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more
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
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
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
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
As reported in our April 25, 2025, blog item, the National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action...more
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more
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
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
According to a March 21, 2025 report issued by the U.S. Department of Agriculture (USDA)’s Foreign Agricultural Service, the scope of Mexico’s recent ban on the cultivation of genetically engineered (GE) corn is “ambiguous”...more
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
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a...more
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
The American Biogas Council (“ABC”) announced on March 3rd its launch of its Biogas Carbon Accounting Tool (“Tool”). The stated goal of the Tool is to: …provide this science-based tool to any entity generating...more
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
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
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2025, that it will begin to accept petitions for nonregulated status according to APHIS biotechnology...more
Artificial intelligence (AI) has emerged as an influential technology, driving notable investments across various industries in recent years. In 2024, venture capital (VC) funding for AI companies reached record levels,...more
USDA Animal and Plant Health Inspection Service (APHIS) announced on January 23, 2025, that it is reinstating its legacy notification procedure as of February 7, 2025, providing a streamlined alternative to permits for...more
Modern gene-editing technology, such as CRISPR/Cas technology, represents a ground-breaking advancement that has transformed our genetic engineering capabilities and has enormous potential for revolutionising medicine, food...more
On January 15, 2025, BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export control concerns about biotechnology. ...more
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
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
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
The U.S. Department of Agriculture (USDA) announced on December 20, 2024, that the United States prevailed in its dispute under the United States-Mexico-Canada Agreement (USMCA) challenging certain Mexican biotechnology...more