The latest issue of the Goodwin Public Company Advisory News Roundup has been posted, covering the period from April 25, 2026 – May 8, 2026. The Roundup highlights the latest developments in SEC and stock exchange regulatory activity, corporate governance
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FDA Signals Potentially Evolving Stance Toward Compounding of Certain Peptides
On April 15, 2026, the U.S. Food and Drug Administration (“FDA”) announced that it will convene a public meeting of the Pharmacy Compounding Advisory Committee (“PCAC”) on July 23-24, 2026, to consider whether to recommend seven (7) peptide bulk drug
Third Circuit Affirms Denial of Stelara Biosimilar Injunction
As previously reported, litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinumab-ttwe) (previously known as SB17), was resolved via a settlement agreement in 2023. Under the terms of the agreement,
FDA Approves Lannett, Lanexa Biologics, and Sunshine Lake Pharma’s Interchangeable Insulin Glargine Biosimilar
On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s LANTUS (insulin glargine). LANGLARA is approved for the treatment of adults
FDA Issues Draft Guidance on Safety Testing for Gene Editing Therapies
SEC Staff Provides Guidance on Pooled Employer Plans
Earlier this week, the SEC’s Division of Investment Management and Division of Corporation Finance recently provided guidance regarding pooled employer plans (PEPs), which are defined contribution retirement plans that permit multiple, unrelated employers to join together in a single plan.
SEC Submits Rescission of Climate-Related Disclosure Rules for OIRA Review
The Office of Information and Regulatory Affairs (OIRA) recently updated its dashboard to disclose that the SEC had submitted a rulemaking titled “Rescission of Climate-Related Disclosure Rules” for review. Once the OIRA review is complete, the Commission will then consider
SEC Proposes Amendments to Permit Optional Semiannual Reporting by Public Companies
The SEC proposed amendments (summarized in this Fact Sheet) that would allow public companies to elect to file semiannual reports on new Form 10-S, rather than filing quarterly reports on Form 10-Q. The SEC also proposed amendments to the
Amneal Agrees to Acquire Kashiv BioSciences for Total Payment up to $1.1 Billion
On April 22, 2026 Amneal Pharmaceuticals, Inc. announced that it entered into an agreement to acquire Kashiv BioSciences, LLC. Under the terms of the agreement, Amneal will pay $375 million in cash and $375 million in equity at closing, along
Eli Lilly to Acquire Kelonia Therapeutics
On April 20, 2026, Eli Lilly & Company (“Lilly”) and Kelonia Therapeutics, Inc. (“Kelonia”) announced an agreement for Lilly to acquire Kelonia in an all-cash transaction expected to close in the second half of 2026. Under the terms of the