The SEC has issued a proposing release titled “Rescission of Rule 14a-8’s Federal Regulation of Shareholder Proposals and Amendments to Rule 14a-4.” If adopted, these proposed amendments would rescind Rule 14a-8, which permits eligible shareholders to include certain
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Cipla and Qilu Announce Exclusive U.S. Licensing and Supply Agreement for Pembrolizumab Biosimilar
On September 3, 2026, InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, announced a strategic partnership and exclusive license with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck’s KEYTRUDA® (pembrolizumab), in
Biocon Enters Ten-Year Pertuzumab Supply Contract in Brazil
On September 8, Biocon Limited (“Biocon”) announced that, in partnership with Bahiafarma, a Brazilian public pharmaceutical laboratory, and Bionovis, a Brazilian biotechnology company, it had secured a ten-year contract to supply Biocon’s pertuzumab biosimilar, BMAB 1500/PERT-IJS, in Brazil. Pertuzumab is
SEC Submits Several Rulemakings for Review
At the end of August 2026, the SEC submitted three significant rulemaking projects to the Office of Information and Regulatory Affairs (OIRA) that would impact public companies and capital raising. OIRA updated its dashboard to indicate that these rulemakings are
FDA and SEC Announce MOU to Increase Collaboration Between the Agencies
On August 31, 2026, the Food and Drug Administration (FDA) and the SEC announced a memorandum of understanding (MOU) that formalizes and streamlines existing interagency cooperation practices by establishing a written framework for sharing information about FDA-regulated products, companies, and
SEC Staff Clarifies Schedule 13G Implications of Shareholder Engagement
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
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