Shots:The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence populationElecsys pTau217 is an in-vitro diagnostic…
Shots:Roche & KlinRisk have received CE-mark approval for the AI-based Kidney Klinrisk Algorithm to assess progressive kidney function decline, integrated into the navify Algorithm SuiteThe chronic kidney disease algorithm panel combines the new Klinrisk Algorithm for early risk assessment with the CE-marked KFRE Algorithm for later disease stages, supporting care across the full…
Shots:The P-III (evERA Breast Cancer) trial evaluated giredestrant + everolimus vs SoC ET + everolimus in ER+, HER2-, LA/M breast cancer pts previously treated with CDK4/6 inhibitors & endocrine therapy (ET) in adj. or LA/M settingsTrial met its co-1EPs of improved PFS in both the ITT & ESR1-mutated populations, while OS showed a…
Shots: Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…
Shots:Roche has entered into a definitive merger agreement to acquire 89bio, incl. its lead asset pegozafermin (FGF21 analog) for metabolic dysfunction-associated steatohepatitis, expanding cardiovascular, renal, & metabolic disease portfolio As per the deal, Roche will acquire 89bio for $14.5/share in an all-cash transaction totaling ~$2.4B, along with one non-tradeable CVR up to an…
Shots:Roche has received the European CE Mark approval for Contivue, a port delivery platform containing Susvimo (Lucentis) for the treatment of neovascular age-related macular degeneration (nAMD); Susvimo (100mg/mL) is under the EMA’s reviewApproval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…
Shots: ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
OMass has entered into an exclusive collaboration & license deal with Genentech to develop & commercialize its preclinical oral small molecule program for inflammatory bowel diseaseAs per the deal, OMass will receive $20M upfront & over $400M in preclinical, development, commercial, & sales milestones, with tiered royalties based on net salesCollaboration leverages OMass’…
Shots:BioPorto has reported the US launch of the ProNephro acute kidney injury (AKI) test through its collaboration with Roche, following its FDA 510(k) clearance on Roche’s cobas c 501 analyzers for hospital clinical laboratoriesProNephro AKI (NGAL) is an AKI biomarker test for pediatric use (3mos.–21yrs.), which helps identifying ICU pts at risk of…
Shots:Bio-Thera & STADA have expanded their partnership to BAT1806, a biosimilar version of Roche’s RoActemra (tocilizumab), whose 20mg/ml vial formulation received EMA’s approval in Jun 2024 for several arthritic conditionsAs per the deal, STADA will obtain exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland & select other countries under its own marketing…

