On September 2, 2026, the staff of the Securities and Exchange Commission’s Division of Corporation Finance issued three new Exchange Act Sections 13(d) and 13(g) and Regulation 13D-G Beneficial Ownership Reporting Corporation Finance Interpretations (CFIs) addressing when shareholder engagement will
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Eli Lilly to Acquire Merida Biosciences
On August 31, 2026, Eli Lilly and Merida Biosciences (“Merida’) announced that they have entered into a definitive agreement for Lilly to acquire Merida. Under the terms of the agreement, Eli Lilly will pay up to $2.875 billion in cash,
AbbVie Submits Regulatory Application to EMA for Subcutaneous SKYRIZI®
On August 27, 2026, AbbVie announced that it submitted an application to the European Medicines Agency (“EMA”) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (“SC”) induction for the treatment of adult patients with moderately to severely active Crohn’s disease. This
Takeda Files BPCIA Suit Against Alvotech for Vedolizumab Biosimilar
On September 1, 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 Alvotech HF (“Alvotech”), alleging that Alvotech’s proposed vedolizumab biosimilar,
Alvotech and Lotus Enter Agreement for Durvalumab and Emicizumab Biosimilars
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
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