Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
Scientists at Bayer AG and Dana Farber Cancer Institute Inc. have identified EGFR (exon 20 insertion [Ex20Ins] mutant) and/or HER2 (erbB2) (Ex20Ins mutant) inhibitors reported to be useful for the treatment of lung cancer.
Scientists at Ascentage Pharma (Suzhou) Co. Ltd. and China Pharmaceutical University have synthesized molecular glue degrader compounds acting as eukaryotic peptide chain release factor GTP-binding subunit ERF3A (GSPT1)/CRBN interaction inducers for GSPT1 degradation reported to be useful for the treatment of cancer, viral infections, aging, immunological disorders and neurological disorders.
Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive cancer. The more common BRCA wild-type (wt) subtype is particularly resistant to standard treatments such as gemcitabine and DNA-targeting agents like olaparib.
Ovarian cancer remains a leading cause of cancer-related deaths among women, with high recurrence rates and resistance to chemotherapy. CAR T-cell therapies present limited efficacy in solid tumors due to tumor heterogeneity and immune suppression in the tumor microenvironment.
Peptide-drug conjugates (PDCs) are emerging as a promising alternative to antibody-drug conjugates (ADCs), offering enhanced tumor penetration and reduced immunogenicity. Carbonic anhydrase IX (CAIX) and epidermal growth factor receptor (EGFR) are both well-validated targets in oncology due to their role in cancer cell survival, invasion and migration.
Avenzo Therapeutics Inc. has gained IND clearance from the FDA for AVZO-023 (formerly ARTS-023), a CDK4-selective inhibitor. The company also announced it has exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing and commercialization rights.
More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
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