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Novocure reported P-II (PANOVA-4) trial data evaluating Tumor Treating Fields (TTFields) with Tecentriq & gemcitabine/nab-paclitaxel as a 1L treatment for mPDAC, with a median TTFields duration of 25.6wks. & median systemic therapy duration of 6 cycles
Trial met its 1EP, showing a DCR of 74.4% in TTFields group (N=78) vs 48% with gem/nab-pac alone…
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Otsuka Pharmaceutical has reported P-III (VISIONARY) trial data evaluating Voyxact (sibeprenlimab-szsi; 400mg, SC, Q4W) vs PBO in IgAN pts at risk for disease progression
Trial showed 82.5% vs 52.6% pts achieved negative microscopic hematuria (0–5/HPF; exploratory EP) at 48wks., with a median time to achieve 0–5/HPF was 9 vs 24wks.; data were presented at…
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Kallisio has received CE certification under the EU MDR 2017/745 for its Stentra intraoral positioning system, with initial deployment planned through selected clinical pilot sites in Germany
Stentra is a patient-specific intraoral device designed to support precise positioning & stabilization during head & neck radiation therapy, integrating seamlessly into existing workflows without requiring changes…
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The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT
Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC
Imdylltra is…
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The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg)
Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies
Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study
Ref:…
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Alteogen has granted Biogen exclusive rights to ALT-B4 (berahyaluronidase alfa) to develop & commercialize SC formulations of two biologics, with an option for Biogen to develop a third product
As per the deal, Alteogen will receive $20M upfront, $10M upon initiation of second product development, along with ~$549M in development, regulatory, & sales milestones…
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The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age
Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.) …
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FDA has granted accelerated approval to Avlayah, an enzyme replacement therapy (ERT), for the treatment of presymptomatic or symptomatic MPS II pediatric pts (≥5kg), along with a RPD PRV to Denali; US availability is expected shortly
Approval was based on the P-I/II trial of Avlayah (QW) in 47 pts, incl. ERT-naïve (n=15) & previously…
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The US FDA has approved Lifyorli (relacorilant) + nab-paclitaxel for the treatment of adults with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic therapies, ≥1 of which included Avastin
NDA was supported by P-III (ROSELLA) assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) with no…
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Merck has entered into a definitive agreement to acquire Terns, incl. its asset TERN-701 asset, expanding its oncology pipeline
As per the deal, Merck will acquire Terns for $53/share in cash, representing a total equity value of ~$6.7B (~$5.7B net of acquired cash); closing is expected in Q2’26
TERN-701 is being evaluated in the…

