On October 1, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) and Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced a new global license, development, and commercialization agreement for up to six potential biosimilar candidates. As with the companies’ previous collaborations, Samsung Bioepis
On October 15, 2026, the SEC’s Division of Corporation Finance issued new and revised Corporation Finance Interpretations (CFIs) providing additional flexibility for registering compensatory awards, including awards assumed in acquisitions and granted before an IPO. The guidance also clarifies registration
On October 13, 2026, the FDA announced the availability of a final guidance for industry entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers,” finalizing a previously issued draft guidance of the same title issued on
On October 1, 2026, Fresenius SE & Co. KGaA (“Fresenius”) announced that it acquired the remaining 45% of mAbxience Holding S.L. (“mAbxience”) from Insud Pharma S.L. and Invim Corporativo, S.L. for up to €750 million, including a contingent payment of
On October 7, the SEC issued a report of investigation under Section 21(a) of the Exchange Act addressing whether members of Climate Action 100+ (CA100) violated the beneficial ownership reporting provisions of the Exchange Act in connection with the election
Tokenized securities are moving from what was once theory to regulated market infrastructure. For the first time, pursuant to an SEC exemptive order, third parties may be able to tokenize and facilitate trading of your company’s stock unless you affirmatively
On October 1, 2026, Sanofi and Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced an expansion of their existing immunology collaboration to develop and commercialize four long-acting antibodies. Sanofi will pay Regeneron $1 billion upfront, with up to an additional $7 billion in
On October 5, 2026, Celltrion USA announced that OMLYCLO® (omalizumab-igec) is commercially available in the United States. OMLYCLO® is the first and only FDA-approved interchangeable biosimilar to Genentech and Novartis’s XOLAIR® (omalizumab).
As we previously reported, the FDA approved the
On September 18, 2026, Sandoz announced a licensing, development, manufacturing, and commercialization agreement with mAbxience for a proposed biosimilar to Genentech’s HEMLIBRA® (emicizumab). HEMLIBRA® is approved for the treatment of hemophilia A.
According to Sandoz, the collaboration would add its
At the 2026 Proxy Disclosure Conference & 23rd Annual Executive Compensation Conference in Orlando, Dave Lynn led a panel on the latest developments from the Division of Corporation Finance. Dave Lynn is a Senior Editor of TheCorporateCounsel.net, CompensationStandards.com and The
