On July 7, 2026, SEC Chair Paul Atkins issued a statement on the Commission’s 2026 Regulatory Agenda. In the statement, Atkins said the SEC is focused on investor protection, capital formation, and market efficiency, and that the agenda is
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FDA Advisory Committee Votes in Favor of Moderna Flu Vaccine Benefit-Risk Profile
On July 30, 2025, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s investigational mRNA influenza vaccine, mRNA-1010 (proposed brand name mFlusiva), outweigh its risks for adults ages 50
FDA Approves Viridian’s LUMVOA for Thyroid Eye Disease
On June 26, 2026, Viridian Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) approved LUMVOA (veligrotug-vvze) for the treatment of thyroid eye disease (“TED”), regardless of disease activity or duration. LUMVOA is Viridian’s first FDA-approved medicine and its
SEC Staff Issues Exemptive Order for Tender of Exchange Offers for Non-Convertible Debt
In April, the Office of Mergers and Acquisitions of the SEC’s Division of Corporation Finance issued an exemptive order providing issuers and, in some cases, third party bidders with the flexibility to shorten the time period during which tender offers
Janssen Files BPCIA Complaint Against Alvotech Related to Golimumab Biosimilar
On June 19, 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA Complaint in the U.S. District Court for the Eastern District of Virginia against Alvotech hf. and Alvotech USA Inc. (collectively, “Alvotech”) for patent
Xbrane Biopharma AB and JOINN Biologics US Inc. Partner to Develop Xdarzane
On June 12, 2026, Xbrane Biopharma AB (“Xbrane”) and JOINN Biologics US Inc. (“JOINN”) announced a strategic partnership to develop Xdarzane, Xbrane’s biosimilar candidate to DARZALEX (daratumumab), which is approved for the treatment of multiple myeloma. Big Molecule Watch has
FDA Expands TOFIDENCE® (tocilizumab-bavi) Label to Include CRS and COVID-19
On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi), an intravenous biosimilar to Genentech’s ACTEMRA® (tocilizumab). The approval expands TOFIDENCE’s indications to include: (1)
Teva Launches AHZANTIVE® Aflibercept Biosimilar in Europe
On June 4, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced the launch of its aflibercept biosimilar, AHZANTIVE®, in Europe. According to Teva’s press release, the launch of AHZANTIVE® pre-filled syringes across European markets commenced in May 2026. The launch follows
Client Alert on the SEC’s Proposed Elimination of “Baby Shelf” Limitations
We recently published a client alert on the SEC’s proposal to eliminate the longstanding “baby shelf” limitations and significantly expand access to Form S-3 and shelf registration for public companies. While the proposal remains subject to public comment and final
Incyte to Acquire Vega Therapeutics, Adding Phase 3 Bleeding Disorder Asset
On June 8, Incyte announced that it has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The transaction would add VGA039, an investigational monoclonal antibody in Phase 3 development for von Willebrand
