The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
China’s National Medical Products Administration has cleared China Grand Pharmaceutical and Healthcare Holdings Ltd. to advance radiopharmaceutical agent ITM-11 (177Lu-edotreotide) to phase III trials in gastroenteropancreatic-neuroendocrine tumors
Scientists at China Resources Shenzhen Bay Development Co. Ltd., National Institutes of Pharmaceutical Research & Development, and Research Institute of Tsinghua University in Shenzhen have described macrocyclic compounds acting as ALK tyrosine kinase receptor and/or ALK tyrosine kinase receptor (mutant) inhibitors reported to be useful for the treatment of malignant neoplasms.
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Abl Bio Inc. have established a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).
Kazia Therapeutics Ltd. has out-licensed paxalisib as a potential treatment for intractable epilepsy in focal cortical dysplasia type 2 and tuberous sclerosis complex disease in a carve-out deal with Sovargen Co. Ltd. for $20.5 million plus sales royalties.
Zhejiang Wenda Pharma Technology Ltd. has synthesized poly (ADP-ribose) polymerase-1 (PARP-1; ARTD1) inhibitors reported to be useful for the treatment of autoimmune disease, cancer and inflammatory disorders.
Humanwell Healthcare (Group) Co. Ltd. has disclosed microtubule destabilizers (tubulin polymerization inhibitors) reported to be useful for the treatment of anemia, asthma, atherosclerosis and rheumatoid arthritis, among others.
Southeast University scientists have reported work leading to the identification of multitargeting histone deacetylase (HDAC) inhibitors as potential anticancer agents.
Cancer Focus Fund LP, an investment fund established in collaboration with The University of Texas MD Anderson Cancer Center, is investing $4.5 million to support a first-in-human trial of Eisbach Bio GmbH’s lead candidate, EIS-12656.
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