NEWS

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2…

August 25, 2025

Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)

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 conditions As per the deal, STADA will obtain exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland & select other countries under its own marketing…

August 25, 2025

argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

Shots: argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG) Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of…

August 25, 2025

Tyra Biosciences Doses First Patient in P-II (BEACH301) Trial of Dabogratinib to Treat Achondroplasia

Shots: Tyra Biosciences has dosed its first patient with dabogratinib (FGFR3 inhibitor) in P-II (BEACH301) trial for the treatment achondroplasia Trial will evaluate dabogratinib in children (3–10 yrs) with achondroplasia & open growth plates across 2 cohorts: treatment-naïve & previously treated with growth-accelerating therapy, enrolling up to 10 pts per dose level (0.125, 0.25, 0.375…

August 22, 2025

Artrya Receives the US FDA’s 510(k) Clearance for Salix Coronary Plaque Module to Detect Coronary Artery Plaque

Shots: The US FDA has granted 510(k) clearance to the Salix Coronary Plaque module for the detection & quantification of coronary artery plaque; Salix is available since Jul 2025 in the US Also, Artrya is partnering with major US hospitals for the upcoming SAPPHIRE study, utilizing Salix Coronary Plaque module, plus it has signed a commercial…

August 22, 2025

Health Canada Approves Roche’s Columvi (Glofitamab) Combination to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: Health Canada has approved Columvi + GemOx for the treatment of ASCT-ineligible pts with r/r diffuse large b-cell lymphoma (DLBCL) Approval was based on P-III (STARGLO) study of Columvi + GemOx vs MabThera/Rituxan + GemOx for r/r DLBCL At mFU of 11.3mos., the trial met its 1EP of OS, reducing the death risk by…

August 22, 2025

Bayer Reports Health Canada’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Health Canada has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

August 22, 2025

AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata

Shots: AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in pts with a mean baseline SALT score of 84 Trial incl. 2 replicate studies (Study 1 & 2) in AA pts (n=1399; 12-64yrs.), where in both studies' Period A, pts were randomized to Rinvoq 15mg, 30mg, or PBO…

August 22, 2025

Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The US FDA has approved Dawnzera (donidalorsen; 80mg SC, Q4W/Q8W) as a prophylactic treatment against attacks in pts (≥12yrs.) with hereditary angioedema; available in the US in coming days Approval was based on P-III (OASIS-HAE) trial & OASISplus OLE study, where P-III showed 81% fewer monthly HAE attacks over 24wks. (87% from 2nd dose) &…

August 22, 2025

Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer

Shots: Agilent Technologies has received the US FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic (CDx) test for colorectal cancer Agilent & BMS partnered to develop the MMR IHC Panel pharmDx (Dako Omnis) to identify dMMR colorectal cancer pts eligible for Opdivo monotx. or Opdivo + Yervoy treatment The…

August 21, 2025

NEWS

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)

argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

Tyra Biosciences Doses First Patient in P-II (BEACH301) Trial of Dabogratinib to Treat Achondroplasia

Artrya Receives the US FDA’s 510(k) Clearance for Salix Coronary Plaque Module to Detect Coronary Artery Plaque

Health Canada Approves Roche’s Columvi (Glofitamab) Combination to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Bayer Reports Health Canada’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata

Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer

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