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Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period
Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…
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Roche has reported CE Mark approval of its Elecsys Dengue Ag test to aid in the diagnosis of an acute dengue virus infection
The Elecsys Dengue Ag is an in-vitro immunoassay for qualitative detection of the dengue virus NS1 antigen in human serum & plasma, designed for use on Roche’s cobas e 801 & cobas…
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Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome
Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…
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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 population
Elecsys pTau217 is an in-vitro diagnostic…
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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 Suite
The 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…
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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 settings
Trial met its co-1EPs of improved PFS in both the ITT & ESR1-mutated populations, while OS showed a…
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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…
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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…
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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 review
Approval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…
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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…

