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Apr 09, 2026
FDA draft biosimilar guidance released March 10, 2026 removes animal toxicology and immunogenicity requirements and accepts some non-U.S. comparator data. The changes are projected to cut development costs by up to 50%.
Feb 17, 2026
Aspire Biopharma filed a provisional patent application for a sublingual powder formulation of meclizine on February 17, 2026, designed to reduce onset time from 60 minutes to minutes. The company plans a 505(b)(2) regulatory pathway for the antiemetic targeting a $450 million global market.
Feb 18, 2026
Pluri Inc. receives patent grant from China National Intellectual Property Administration for its proprietary 3D immune cell expansion and activation technology, expanding global IP protection across U.S., China, Japan, Korea, Australia and Israel.
Feb 17, 2026
BioNxt Solutions Inc. receives European Patent No. 4539857 for its proprietary sublingual cladribine oral thin film drug delivery technology, providing protection across up to 39 European Patent Convention states through at least June 14, 2043.
Feb 14, 2026
Longeveron Inc. appointed Stephen H. Willard as CEO effective February 11, 2026, replacing interim CEO Than Powell. The appointment comes as the company expects top-line results from its pivotal Phase 2b trial for Hypoplastic Left Heart Syndrome in Q3 2026.
Feb 13, 2026
Artificial intelligence is accelerating drug discovery from molecule screening to clinical trials, but legal uncertainty over patent ownership and profit distribution threatens to slow progress as the technology reshapes pharmaceutical development.
