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NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

Shots: NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached…

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Akari and Whitehawk Partner to Evaluate Dual-Payload ADC Approach

Shots: Akari has entered into a strategic research collaboration with Whitehawk to evaluate Akari’s PH1 spliceosome-modulating payload tech in combination with Whitehawk’s TOP1i ADC platform As per the deal, Akari will lead the design, execution, & evaluation of the research program, which will incl. multiple preclinical workstreams assessing dual-payload compatibility & potential synergies Collaboration begins…

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Telix Pharmaceuticals

Telix Reports the First Patient Dosing in P-III (LUTEON) Trial of TLX250-Tx for Renal Cancer

Shots: Telix has dosed the first patient with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the P-III (LUTEON) study to identify eligible pts with CAIX-positive tumors in r/r clear cell renal cell carcinoma (ccRCC) LUTEON trial in Australia is part of Telix’s global development program for TLX250-Tx, alongside the P-IIa (LUTEON ATLAS) study in the US…

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Samsung Bioepis and Harrow Present Interim P-IV PMS Study Data on SB11 (Biosimilar, Lucentis) at ASRS 2026

Shots: Samsung Bioepis & Harrow have reported interim data from a P-IV post-marketing surveillance study on SB11, a biosimilar version of Lucentis (ranibizumab), conducted in South Korea from May 2022 to May 2026 The interim analysis incl. 298 of 305 enrolled pts (182 treatment-naïve & 116 switched), with investigator-determined dosing intervals & follow-up through 24wks.…

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Personalis

Tempus AI to Acquire Personalis for ~$1.5B

Shots: Tempus AI has entered into a definitive agreement to acquire Personalis, expanding Tempus' capabilities in minimal residual disease (MRD) As per the deal, Personalis shareholders will receive $16.25 per share, valuing the company at an enterprise value of $1.5B, net of Tempus AI’s existing ownership interest; closing expected in late 2026 or early 2027…

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Samsung Bioepis and Organon

Organon and Samsung Bioepis Expand Commercialisation Agreement to Broaden Biosimilar Access in Australia

Shots: Organon & Samsung Bioepis have expanded their development and commercialisation agreement to commercialise a new biosimilar in Australia As per the deal, Organon will receive exclusive commercial rights to the biosimilar in Australia while Samsung Bioepis will be responsible for full development, manufacturing & regulatory responsibilities The amended agreement expands their collaboration to 4…

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Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older

Shots: The EMA has accepted a submission to extend marketing authorization of Ebglyss (lebrikizumab) to pts (6mos. to <18yrs., weighing <40kg) with mod. to sev. atopic dermatitis Application was supported by interim data from the pediatric clinical program, incl. the ADorable-1 evaluating Ebglyss in pts (6mos. to <18yrs.), & the ADorable-2 LTE study assessing safety…

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