South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.
The congressional finger-pointing at pharmacy benefit managers (PBMs) continues. The latest singling out is in a bipartisan letter from four House members calling on the U.S. Department of Justice to investigate and hold PBMs accountable for the role they played in the nationwide opioid crisis.
Kiromic Biopharma Inc. and two former senior officials have settled with the U.S. SEC to resolve charges involving nondisclosure of U.S. FDA clinical holds on two cancer candidates before and after a July 2021 follow-on public offering that raised $40 million the company desperately needed.
After raising AU$40 million (US$25.9 million) earlier this year to advance lead candidate VP-001 for treating retinitis pigmentosa type 11, PYC Therapeutics is now advancing PYC-003 to the clinic for polycystic kidney disease.
Janux Therapeutics Inc. CEO David Campbell said the firm will be talking with the U.S. FDA about “what we may or may not be able to do [in order to get JANX-007] to patients more rapidly,” though he noted that the agency has “primarily been focused on overall survival” in considering prostate cancer drugs, so more work on that endpoint may be required. “We’ll keep that in mind,” he said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aavantgarde, Applied Therapeutics, Biocon, Bluebird, Cytokinetics, Everest Medicines, Johnson & Johnson, Pfizer, PTC, Rigel, Sana, Stallergenes, Travere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alligator, Atom, China Medical Systems, Hepion, Medac, Medexus, Merus, Partner, Pharma Two B, Pulmokine, Sernova, Xoma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Autolus, Galderma, Gilead, Hua, Maplight, Merus, MBX, Revolution Medicines, Senti, Soligenix.
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