An exec said the company is confident it can ensure testing for the biomarker becomes routine for the drug, which is the first FDA-approved medicine to target CLDN18.2.
Astellas is confident that it can ensure widespread testing for Claudin18.2 (CLDN18.2) among patients with gastric and gastroesophageal junction (G/GEJ) cancer as the first company to win approval for a drug targeting that biomarker, Vyloy (zolbetuximab-clzb).
The US Food and Drug Administration approved Vyloy on 18 October in combination with fluoropyrimidine- and platinum-containing chemotherapy for adults...
Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.
The drug is one of multiple candidates in the class that have been pulled from development, though it is not the company’s lead candidate.
Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.
The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.
The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The company will start shipping its newly launched phenylketonuria drug within two weeks and has bought back global net sales obligations for the treatment.
