LXR Biotechnology, Inc.
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Latest From LXR Biotechnology, Inc.
Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says
Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.
No Korea-Originated New Drugs Approved Domestically In 2023
Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.
Deal Watch: Gilead Acquires Xilio’s IL-12 Activating Candidate
Plus deals involving Avalo/AlmataBio, AbbVie/Parvus, NovaBay/Eyenovia, Bayer/Aignostics, Merck & Co./Pearl, tech transfer agreements and deals in brief.
Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts
Oncologic Drugs Advisory Committee reps and the Oncology Center of Excellence director go behind the scenes to discuss FDA interactions with panelists, how opinions can change during a meeting, and why the voting question is important.
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