China's Dizal has won the first approval worldwide, in its home market, for a JAK1 inhibitor in relapsed/refractory peripheral T-cell lymphoma (PTCL), based on a pivotal Phase II trial. The biotech is also planning a Phase III study with the molecule for second-line PTCL.

The Japanese firm has decided to shrink its oncology portfolio by transferring its rights to oxaliplatin in Japan, along with a portfolio of generics, to Takata. Though Yakult will maintain an interest in the area through irinotecan and several other anticancers, its has said future R&D investment will shift more towards the microbiome.

In a letter to Commissioner Robert Califf, the Patient, Consumer and Public Health Coalition says medical product center directors and other senior staff should refrain from trying to sway advisory committee votes and be reminded that overruling decisions of their own scientific staff undermines the public trust.

More than seven months after the Oncologic Drugs Advisory Committee voted that Pepaxto and Copiktra had negative benefit-risk profiles in their labeled indications, the drugs' approvals remain intact. Oncopeptides is still considering whether to heed the FDA's request to withdraw the Pepaxto NDA, even though the drug is not currently marketed. Secura Bio says Copiktra remains on the market and available for prescribing.