On April 26, 2026, Sun Pharmaceutical Industries Limited (“Sun Pharma”) and Organon & Co. (“Organon”) announced an agreement for Sun Pharma to acquire all outstanding shares of Organon in an all-cash transaction valued at $11.75 billion and expected to close in early 2027. Organon will merge with a subsidiary of…
AbbVie Submits Regulatory Application to FDA for Subcutaneous SKYRIZI On April 27, 2026, AbbVie announced that it has submitted a regulatory application to the FDA seeking approval for SKYRIZI (risankizumab-rzaa) for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn’s disease. AbbVie states that its application…
On April 27, 2026, Intellia Therapeutics (“Intellia”) announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA for lonvoguran ziclumeran (lonvo-z), an investigational therapy for hereditary angioedema (HAE). Lonvo-z, previously known as NTLA-2002, is designed as a one-time, outpatient-administered treatment using in vivo…
On April 16, 2026, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in a patent dispute between Teva Pharmaceuticals (“Teva”) and Eli Lilly & Co. (“Lilly”). The case stems from a 2018 lawsuit in which Teva alleged that Lilly infringed three patents related to methods…
The U.S. Food and Drug Administration (“FDA”) recently released its congressional justification for the 2027 Fiscal Year budget. Overall, the FDA proposed a total budget of $7.2 billion, an overall increase of 3.3% above the 2026 Fiscal Year enacted level. As part of the legislative proposals, the FDA included a…
On April 7, 2026, Biocon Limited announced that it had launched BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) in the United States. Both products are RANK ligand inhibitors used to treat conditions such as osteoporosis and cancer-related skeletal complications. BOSAYA™ and AUKELSO™ have been designated as interchangeable with their corresponding reference products,…
On March 26, 2026, the U.S. Food and Drug Administration approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel), the first gene therapy treatment for pediatric patients with severe Leukocyte Adhesion Deficiency Type I (LAD-I). LAD-I is an inherited immune deficiency cause by mutations in the ITGB2 gene that leaves patients susceptible to…
On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval increases the maximum dosing interval from 16 weeks to 20…
On March 30, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced that the U.S. Food and Drug Administration (“FDA”) has approved its denosumab biosimilar, PONLIMSI™ (denosumab-adet). PONLIMSI™ has been approved for all indications of the reference product, Amgen’s PROLIA®, including the treatment of osteoporosis in postmenopausal women at high risk for…
On March 31, 2026, the District Court for the District of New Jersey entered a Consent Order and Judgment in the BPCIA litigation Amgen brought against Henlius and Organon concerning their denosumab biosimilars, BILPREVDA® (denosumab‑nxxp) and BILDYOS® (denosumab‑nxxp), following a settlement between the parties. Under the consent judgment, Henlius and…