RegeneRx Biopharmaceuticals, Inc.
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Latest From RegeneRx Biopharmaceuticals, Inc.
Samsung Bioepis has struck a US settlement with Johnson & Johnson that will allow partner Sandoz to launch the pair’s SB17 ustekinumab biosimilar to Stelara in early 2025, assuming FDA approval.
Aldeyra’s bid to rely on a single Phase III trial after an initial one failed is rejected by FDA, but firm already has a special protocol assessment under review for a trial that could provide the symptom data it says agency needs to approve the RASP modulator in dry eye.
Aldeyra already has a special protocol assessment under review at the FDA for a trial to provide the symptom data the agency said is needed for approval of the RASP modulator in dry eye disease.
Office of Inspector General analysis could add momentum to reforms of the rebating system.
- Large Molecule
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