On September 28, 2026, in a response to a request from Goldman Sachs, the SEC’s Division of Corporation Finance issued a no-action letter stating that it would not recommend enforcement action related to Exchange Act Rules 14a-3(a), 14a-4(d)(2), 14a-4(d)(3), 14a-4(f)
Goodwin Procter Blogs
Latest from Goodwin Procter
Ultragenyx’s FAYUVI Becomes First FDA-Approved Treatment for Sanfilippo Syndrome Type A
Ultragenyx Pharmaceutical, Inc. has announced FDA approval for FAYUVI (rebisufligene etisparvovec-hopf), a first-ever treatment to stop or slow the progression of mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. MPS IIIA is an ultra-rare inherited
Parties Dispute Intent Standard in STELARA® Antitrust Appeal
As we previously reported, portions of CareFirst’s antitrust claims concerning STELARA® (ustekinumab) survived summary judgment in December 2025.
On January 14, 2026, the U.S. District Court for the Eastern District of Virginia reconsidered that decision and granted summary judgment
BMS and Ono File BPCIA Suit Against Amgen for Nivolumab Biosimilar
On September 8, 2026, Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., (collectively, “BMS”) and Ono Pharmaceutical Co., Ltd. (“Ono”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Amgen Inc. (“Amgen”), alleging
SEC Proposes Modernizing Proxy Solicitation Rules
The SEC has issued a proposing release titled “Proxy Solicitation Modernization.” If adopted, the proposed amendments would eliminate certain annual report delivery and exempt solicitation filing requirements, remove a 20-business-day delivery period for certain proxy statements and prospectuses,
SEC Proposes Rescinding the Federal Shareholder Proposal Rule
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
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