On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...more
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
Over the summer, Delaware enacted a number of amendments to the General Corporation Law of the State of Delaware (the “DGCL”). The amendments were largely crafted in response to several recent decisions by the Delaware...more
On March 21, 2024, the FDIC unveiled proposed revisions to its Statement of Policy (SOP) on Bank Merger Transactions, which was last amended in 2008. The revisions would increase scrutiny of bank mergers, particularly mergers...more
The New Jersey Cannabis Regulatory Commission (NJ-CRC) approved regulations for cannabis consumption lounges during its January 17th meeting. These rules establish a framework for medical and adult-use operators seeking to...more
Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
With the passage of SB-184 (the “Bill”), California — like Maine, New York, and several other states — has addressed “pervasive” mergers and acquisitions across the healthcare industry by requiring prior notice to regulators...more
On May 26, 2023, the Governor of Minnesota signed into law Minnesota bill HF 402 to increase government oversight of health care transactions that occur in Minnesota or involve Minnesota-based health care entities. Minnesota...more
In a prior blog post, we summarized proposed legislation that would have conferred upon the New York State Department of Health (DOH) the authority to review and approve "material transactions" involving a "health care...more
On March 28, 2023, the Maine Legislature proposed legislation that would prohibit certain “health care entities,” including medical and other professional practices, licensed health care facilities, and providers of...more
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more
In Sutter Hill Management Corporation v. Mpire Capital Corporation (Sutter), the British Columbia Court of Appeal found that the acquiror of an Abbotsford, B.C. care home had breached the purchase and sale agreement by...more
On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent...more
What Is the FTC's New "Prior Approval" Policy? At the end of an FTC investigation into the competitive impact of a merger, the agency may (i) take no action (allowing the parties to close), (ii) challenge the transaction...more
On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy for Europe” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The...more
If a proposed bill by the California Senate is passed, parties to certain post-pandemic healthcare transactions involving private equity groups, hedge funds, healthcare systems, facilities, and provider groups would need to...more