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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…
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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…
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The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients
The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing…
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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 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…
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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…
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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…
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The US FDA has granted clearance to the Onclarity HPV Self-Collection Kit & approved the BD Onclarity HPV Assay for at-home use, expanding access to cervical cancer screening
The kit is tested with the BD Onclarity HPV Assay, detecting all high-risk HPV genotypes with individual & pooled results, & processed on the automated BD…
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Vanda Pharmaceuticals has initiated the Thetis study assessing Nereus (tradipitant) vs PBO for the prevention of vomiting in pts receiving GLP-1 receptor agonist therapies
The Thetis study will assess the proportion of pts free from vomiting episodes as the 1EP, with Vanda expecting topline results by Q4’26 & noting that additional data may be…
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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…

