NEWS

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

Shots: AstraZeneca has reported P-III (PREVAIL) trial assessing gefurulimab vs PBO in 260 gMG adults for 26wks. across North America, EU, & APAC region; eligible pts could then enter an ongoing OLE study Trial met its 1EP & all 2EPs, showing significant improvement in MG-ADL total score from baseline at 26wks. in adults with AChR…

July 24, 2025

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…

July 24, 2025

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Shots: The EC has approved Darzalex SC (daratumumab) for the treatment of adults with high‑risk smouldering multiple myeloma (SMM) Approval was based on the P-III (AQUILA) study data assessing Darzalex SC monotx. vs active monitoring in high-risk SMM pts (n=390) At a mFU of 65.2mos., trial showed improved PFS, with 63.1% vs 40.8% pts alive…

July 24, 2025

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Shots: Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…

July 23, 2025

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Shots: The EC has approved a label extension for Imbruvica (ibrutinib) + R-CHOP alternating with R-DHAP (without ibrutinib), followed by ibrutinib monotx., for the treatment of previously untreated MCL pts ineligible for ASCT Approval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib…

July 23, 2025

The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone loss Additionally, Fresenius & Amgen…

July 23, 2025

HMNC Brain Health and Spruce Biosciences Dose First Patient in P-II (TAMARIND) Trial of Tildacerfont for Major Depressive Disorder

Shots: HMNC & Spruce has dosed the first pts with tildacerfont in P-II (TAMARIND) trial for the treatment of major depressive disorder (MDD) The P-II (TAMARIND) trial will assess tildacerfont vs PBO in 88 MDD adults across the UK for an 8wk. treatment period followed by a 4wk. follow-up period to evaluate change in Hamilton…

July 23, 2025

Slingshot AI launches Ash for Personalized Mental Health Support

Shots: Slingshot AI has launched Ash, a personalized mental health support app, which is now available on both iOS & Android platforms Slingshot AI also secured a Series A extension funding co-led by Radical & Forerunner Ventures, joined by existing investors a16z, Felicis, & Menlo, bringing its total capital raised to $93M Ash is powered…

July 23, 2025

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Shots: The EC has approved Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, ER+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trial Trial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, which showed improved PFS…

July 23, 2025

Concentra Biosciences Enters a Merger Agreement to Acquire iTeos Therapeutics

Shots: Concentra Biosciences has entered into a definitive merger agreement to acquire iTeos Therapeutics As per the deal, iTeos Therapeutics’ shareholders will receive $10.047 per share in cash, along with a non-transferable CVR, which entitles them to 100% of iTeos' net cash exceeding $475M at closing & 80% of net proceeds from the sale of…

July 22, 2025

NEWS

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

HMNC Brain Health and Spruce Biosciences Dose First Patient in P-II (TAMARIND) Trial of Tildacerfont for Major Depressive Disorder

Slingshot AI launches Ash for Personalized Mental Health Support

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Concentra Biosciences Enters a Merger Agreement to Acquire iTeos Therapeutics

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