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FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo
For neoadj. setting, approval was backed by DESTINY-Breast11…
NEWS
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Protara has reported 12mos. data from Cohort A of the ongoing P-II (ADVANCED-2) trial assessing TARA-002 in pts with carcinoma in situ or CIS (± Ta/T1) NMIBC who are BCG-Unresponsive or BCG-Naïve; P-III (ADVANCED-3)trialin BCG-Naïve pts to initiatein H2’26
The BCG-Naïve group (n=31), incl. 29 evaluable pts for efficacy, with 27 evaluable at 6mos.…
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The 2 studies evaluated IPDE therapy for lower urinary tract symptoms (LUTS) secondary to BPH, assessing delivery of paclitaxel-eluting bioabsorbable implants through transperineal & transrectal approaches
In the transperineal study (n=20), IPDE improved IPSS by 15 points & Qmax by ~4 mL/s at 1yr., achieving benefit in 80% pts, while the transrectal study (n=11)…
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MEDIPOST has reported the P-III trial data assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over a 52wk. follow-up period across 13 Japanese sites
Trial met both co-1EPs of WOMAC knee pain & function scores, and ICRS cartilage repair grading. Improvements were also observed across all 2EPs, incl. VAS pain…
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The Korean MFDS has approved Eyzanfy (ALT-L9), a biosimilar version of Eylea (aflibercept)
In 2025, ALT-L9 received EC approval as a brand name of Eyluxvi
Approval was based on P-III trial across 12 countries in 431 wAMD pts, demonstrating Eyluxvi’s efficacy, safety, and therapeutic equivalence comparable to Eylea
Ref: Alteogen | Image: Alteogen | Press Release
Related News:- Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s…
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The US FDA has granted 510(k) clearance for EndoTool IV Cloud, a cloud-based patient-specific insulin dosing platform designed for hospitalized pts requiring IV insulin therapy
Built on the same dosing algorithm as EndoTool IV, the cloud-based platform is designed to support individualized insulin dosing while enabling more scalable implementation, streamlined maintenance, & reduced reliance…
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Biogen has reported the global P-II (CELIA) trial data assessing diranersen [60mg (Q24W), 115mg (Q24W), or 115mg (Q12W); intrathecal) vs PBO over 76wks. in 416 pts with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia
Although CELIA did not meet its 1EP of dose response on CDR-SB change from baseline…
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The US FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of pts (≥12yrs.) with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause
Approval was based on the P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks.
Trial met…
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Trial enrolled 695 MIBC pts undergoing radical cystectomy who were ineligible for or declined cisplatin & randomized them to Arm 1 [neoadj. 3 Imfinzi + EV cycles with Imjudo (2 cycles), then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or…
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Revvity has received the US FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding its endocrine diagnostics portfolio
The portfolio enables direct ChLIA measurement of total testosterone, SHBG, & free testosterone, supporting both first & second-line diagnostic testing for suspected male hypogonadism
Processed on IDS’ random-access automation platforms, the expanded portfolio enables…

