Skip to content Skip to footer

NEWS

DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer
Shots: China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…
Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN
Shots: Health Canada has approved Empaveli (pegcetacoplan) for patients (≥12yrs.) with C3 glomerulopathy (C3G) or primary IC-MPGN to reduce proteinuria, marking the first approved therapy for these indications in Canada Approval was based on the P-III (VALIANT) study, where Empaveli demonstrated a 68% reduction in proteinuria (uPCR), stabilization of kidney function, and clearance of C3…
Kymera Therapeutics Reports Gilead’s Option Exercise to License KT-200, a CDK2 Molecular Glue Degrader
Shots: Gilead Sciences has exercised its option to exclusively license KT-200, a first-in-class oral CDK2 molecular glue degrader, from Kymera Therapeutics under their existing collaboration The option exercise triggers a $45M milestone payment to Kymera; the company remains eligible for up to $750M in total payments, including milestones and tiered royalties on net sales Gilead…
Imagene AI Partners with Daiichi Sankyo to Advance Multimodal Biomarker Discovery in Oncology
Imagene AI has entered into a collaboration with Daiichi Sankyo to advance biomarker discovery and response prediction across oncology drug development programs Under the collaboration, Daiichi Sankyo will leverage Imagene’s OI Suite, powered by the CanvOI foundation model, to integrate H&E and IHC whole-slide images with molecular and clinical data to enhance biomarker identification and…
DeepCyte Secures $1.5M to Advance AI-Driven Single-Cell Toxicology in Drug Development
Shots: DeepCyte, a techbio startup focused on advancing AI-powered toxicology for drug development, has officially launched with $1.5 million in seed funding, introducing two solutions to help biopharma teams detect, predict, and understand drug toxicity in human cells at single-cell resolution DeepCyte's MetaCore, a high-throughput single-cell metabolomics platform, leverages laser-based sampling and mass spectrometry to…
C4 Therapeutics and Roche Enter Oncology Collaboration Worth Over $1B to Develop DAC with Payload
Shots: C4 has entered into a new collaboration with Roche to develop degrader-antibody conjugates (DACs), combining targeted protein degradation with ADCs for cancer treatment Partnership will focus on two oncology programs against undisclosed targets, leveraging C4’ Torpedo platform for degrader payloads, while Roche will select & design the antibodies, conjugate them to payloads, & lead…
Sanofi
Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada
Shots: Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination Nuvaxovid…