The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.
Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA.
The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.
Only a few months after reporting what it called “unprecedented” phase I data for its BCR-ABL1 tyrosine kinase inhibitor in chronic myeloid leukemia, Terns Pharmaceuticals Inc. agreed to an acquisition by Merck & Co. Inc. valued at about $6.7 billion. For Terns, the deal validates the decision last year to switch focus from its metabolic pipeline to oncology and, for Merck, it’s the latest move as the big pharma looks to shore up its offerings ahead of patent expirations for cancer blockbuster drug Keytruda (pembrolizumab).
TYK Medicines Inc. has synthesized cyclin-dependent kinase 4 (CDK4) inhibitors designed for use in the treatment of cancer, infections, and metabolic, inflammatory cardiovascular and inflammatory disorders.
Arvinas Operations Inc. has disclosed proteolysis targeting chimera (PROTACs) compounds comprising a cereblon (CRBN) E3 ubiquitin ligase-binding moiety covalently linked to a B-cell lymphoma 6 protein (BCL-6)-targeting moiety through a linker with potential for use in the treatment of cancer.
Rybodyn Inc. has announced the initial close of a $10 million seed financing to support its work decoding the dark proteome using an AI-powered novel sequencing and discovery platform. The financing will accelerate the company’s transition from foundational discovery into scaled platform execution and progress early-stage programs into IND-enabling studies.
Cutaneous squamous cell carcinoma (cSCC) is the second most common skin cancer, arising from abnormal proliferation of epidermal keratinocytes due to chronic UV exposure. While highly curable (>90%) with surgical excision when detected early, it carries a significant risk of local invasion and metastasis if left untreated.
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
RSS
