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ISS Indefinitely Halts Director Diversity Considerations
On February 11, 2025, Institutional Shareholder Services (ISS) announced, that, for shareholder meeting reports published on or after February 25, 2025...
Goodwin Procter LLP
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SEC Announces Open Meeting To Consider Policy On Mandatory Arbitration Provisions
On September 10, 2025, the SEC announced that an open meeting will be held on September 17, 2025 and the agenda items include...Goodwin Procter LLP - Article
SEC Announces The Appointment Of A New Director Of The Division Of Corporation Finance
On September 10, 2025, the SEC announced that James J. Moloney, a partner at Gibson Dunn, has been named Director of the agency's Division of Corporation Finance, effective in October.Goodwin Procter LLP - Article
SEC Names Acting Chair Of The PCAOB
On July 21, 2025, the SEC announced that it has designated George R. Botic to serve as Acting Chair of the Public Company Accounting Oversight Board, effective July 23, 2025.Goodwin Procter LLP - Article
Massachusetts Attorney General Settles With Student Loan Lender For Unlawful Practices Related To The Use Of AI
This Thursday, July 10, Massachusetts Attorney General Andrea Joy Campbell announced a $2.5 million settlement with a company that offers education financing products based in Delaware.Goodwin Procter LLP - Article
A Look Ahead In Life Sciences: What We Are Tracking In The First Quarter Of 2025 And Beyond
To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics...Goodwin Procter LLP - Article
Accord Receives Positive EMA Opinion For Two Denosumab Biosimilars
On April 2, 2025, Accord received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for two denosumab biosimilars...Goodwin Procter LLP - Article
Alvotech And Teva Announce FDA Approval Of Additional Presentation For Ustekinumab Biosimilar
On October 22, 2024, Alvotech and Teva announced that SELARSDI™ (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL)...Goodwin Procter LLP - Article
Celltrion Adalimumab Biosimilar Granted Interchangeability Designation
On April 14, 2025, Celltrion, Inc. announced that the U.S. Food and Drug Administration granted an interchangeable designation to YUFLYMA (adalimumab-aaty)...Goodwin Procter LLP - Article
Celltrion Announces Commercial Availability Of ZYMFENTRA™ (Infliximab-dyyb)
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.Goodwin Procter LLP - Article
Celltrion Submits BLA For Omalizumab Biosimilar
Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria...Goodwin Procter LLP - Article
FDA Approves Celltrion's New Pediatric Formulation Of STEQEYMA, Expanding Dosing Flexibility
On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection.Goodwin Procter LLP - Article
FDA Approves Celltrion's STEQEYMA (Ustekinumab-stba)
On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen's STELARA. STEQEYMA is approved for subcutaneous injection.Goodwin Procter LLP - Article
FDA Approves Moderna's MRESVIA Vaccine
On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine ("RSV"), mRESVIA (mRNA-1345).Goodwin Procter LLP - Article
FDA Approves Samsung's Eculizumab Biosimilar
Samsung Bioepis ("Samsung") announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion's SOLIRIS. EPYSQLI has been approved for the treatment of patients...Goodwin Procter LLP - Article
Henlius Receives Orphan-Drug Designation For HLX22 (Anti-HER2 MAb) For Gastric Cancer
On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22...Goodwin Procter LLP - Article
Kashiv BioSciences Reports Positive Topline Results For XOLAIR® Biosimilar Candidate ADL-018
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria.Goodwin Procter LLP - Article
Teva And Prestige Biopharma Enter Licensing Agreement To Commercialize Their Trastuzumab Biosimilar
On October 20, 2025, Teva Pharmaceuticals International GmbH ("Teva") announced a licensing agreement with Prestige BioPharma Ltd. ("Prestige BioPharma") to commercialize TUZNUE® (trastuzumab), a biosimilar to Genentech's HERCEPTIN (trastuzumab), in a majority of European countries.Goodwin Procter LLP - Article
Vertex Presents New CASGEVY® Data In Patients 5-11 Years And Announces Plan For Global Regulatory Submissions
On December 6, 2025, Vertex Pharmaceuticals Inc. ("Vertex") announced data from several studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel)...Goodwin Procter LLP - Article
Celltrion Wins Brazilian Federal Tender For Trastuzumab For Fifth Consecutive Year
On September 13, 2024, Celltrion announced that its Brazilian subsidiary won the Federal Government of Brazil's bid to supply HERZUMA (trastuzumab-pkrb) for the fifth consecutive year...Goodwin Procter LLP