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Tempest Therapeutics Enters Exclusive Option Agreement with Senlang for In Vivo CAR-T Platform and Pipeline
Shots: Senlang has granted Tempest an exclusive option to license its CD7-targeted lentiviral vector platform & in vivo CAR-T portfolio, incl. a BCMA/GPRC5D dual-targeting candidate for R/R MM & additional assets for hematologic malignancies & autoimmune diseases Senlang’s platform uses targeted lentiviral vectors to deliver CAR transgenes to endogenous CD7+ T cells and NK cells,…
2 days ago
Cebreo Medical Reports CE Mark Approval of NeuroBuds for Ambulatory EEG Monitoring
Shots: Cebreo Medical has reported the CE Mark approval of its NeuroBuds device to be used unassisted by the patient at home for extended, ambulatory electroencephalogram (EEG) monitoring NeuroBuds, designed to resemble a hearing aid, minimizes the stigma & burden of long-term EEG monitoring, enabling comfortable, unassisted use for ~3mos. with repeat measurements Cebreo Medical…
2 days ago
Curium Receives FDA Approval for Bexlutry to Treat GEP-NETs
Shots: The US FDA has approved Bexlutry (lutetium Lu 177 dotatate injection) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), covering foregut, midgut, & hindgut NETs Bexlutry is a radioligand equivalent developed through the 505(b)(2) regulatory pathway, targeting Lutathera. The approval is supported by published evidence & targeted bridging data demonstrating…
2 days ago
GSK Inks ~$750M Deal with Chimagen to Acquire a Trispecific TCE Program
Shots: GSK has entered into an agreement with Chimagen Biosciences to acquire full global rights to a trispecific T cell-engager (TCE), building on its existing relationship with Chimagen following a previous agreement to acquire CMG1A46 As per the deal, Chimagen will receive an upfront fee for Chimagen’s TCE program, with additional development & commercial milestones…
2 days ago
Organon Reports the US FDA sNDA Acceptance for Miudella
Shots: The US FDA has accepted the sNDA of Miudella (hormone-free copper intrauterine system) for an extended duration of use for up to 6yrs. with the PDUFA action date expected in Q2’27   Miudella was evaluated in 3 trials across US in 1904 women (17-45yrs.), where the efficacy cohort (17-35yrs.) of the P-III trial (n=1397) showed…
3 days ago
Telix Pharmaceuticals
Telix Gains US FDA Approval for Pixclara for Brain Cancer Imaging
Shots: The US FDA has approved Pixclara (floretyrosine F 18) for pts (≥1mos.) as the FET-PET imaging drug for glioma, enabling PET imaging to help differentiate recurrent or progressive glioma from treatment-related changes Pixclara comprises a small-molecule targeting agent & fluorine-18; it binds with LAT1 & LAT2 transporters after IV administration, allowing the radioisotope’s emissions…
3 days ago
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