On August 21, 2026, Alvotech announced a licensing and commercialization agreement with Lotus Pharmaceutical (“Lotus”) for AVT34, a proposed biosimilar to IMFINZI® (durvalumab), and AVT87, a proposed biosimilar to HEMLIBRA® (emicizumab).
In the United States, Alvotech and Lotus will have
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FDA Approves Ultragenyx’s GENGLYCOS™ Gene Therapy for GSDIa
On August 19, 2026, Ultragenyx Pharmaceutical announced that the FDA granted accelerated approval to its GENGLYCOS (pariglasgene brecaparvovec-opnr) for patients eight years and older with glycogen storage disease type Ia (GSDIa). The therapy is approved to reduce daily cornstarch intake
FDA approves Regeneron’s PASATRU™ (garetosmab-grts) for Fibrodysplasia Ossificans Progressiva
On August 19, 2026, the U.S. Food and Drug Administration approved Regeneron’s PASATRU (garetosmab-grts) for the treatment of adults with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder characterized by progressive heterotopic ossification (HO), the formation of bone in
Biocon Announces Supplemental U.S. FDA Approval for Prefilled Autoinjector for YESINTEK
On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and 90 mg/mL. YESINTEK® was originally approved by the FDA on
Takeda Files BPCIA Suit Against Polpharma Biologics For Vedolizumab Biosimilar
On August 26, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Polpharma Biologics S.A. (“Polpharma”), alleging that Polpharma’s vedolizumab biosimilar,
FDA Addresses FAQs on Developing Potential Cellular and Gene Therapy Products
On August 20, 2026, the FDA published guidance intended to provide answers to frequently asked questions about the development of cellular and gene therapy (“CGT”) products to help facilitate the development of safe, effective, and high-quality CGT products. The FDA’s
SEC Submits Executive Compensation Disclosure Rulemaking for OIRA Review
On August 26, 2026, the SEC submitted a rule proposal titled “Executive Compensation Disclosure Reform” to the White House’s Office of Information and Regulatory Affairs (OIRA). Those SEC rulemaking initiatives that are under review by OIRA are listed on a
Glass Lewis Announces Multi-Perspective Framework
In October 2025, Glass Lewis announced plans to shift from singularly-focused research and vote recommendations anchored by a global voting policy toward providing multiple perspectives reflecting the viewpoints of clients.
On August 26, 2026, Glass, Lewis & Co. sent a
Biocon Launches Aflibercept Biosimilar in the United States
On August 3, 2026, Biocon Limited announced the commercial launch of its biosimilar YESAFILI (aflibercept-jbvf) in the United States. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor that is used to treat various ophthalmic conditions. YESAFILI references Regeneron’s EYLEA
Deadline Approaching: OIG Seeks Input on Anti-Kickback Safe Harbors for Clinical Trial Participant Remuneration
On June 24, 2026, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Request for Information (“RFI”) seeking stakeholder input on payments received by individuals in connection with clinical trial participation. Specifically,