DualityBio Inks $1B+ Deal with Genentech to Develop Next-Generation ADCs

Shots: DUALITYBIO has entered into a collaboration & license agreement with Genentech to develop next-generation ADCs, leveraging DUALITYBIO’s DUPAC (DualityBio Unique Payload Antibody Conjugate) platform DualityBio will discover & develop ADCs against Genentech-selected oncology targets using DUPAC payloads, leading discovery & early global development, while Genentech will secure exclusive global rights & take over development…

ByRidhi RastogiAugust 31, 2026

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Takeda Reports the US FDA Approval of Mimrylo (Rusfertide) for Polycythemia Vera

Shots: The US FDA has approved Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV) Approval was backed by the P-III (VERIFY) trial (n=293), which met all efficacy endpoints, showing higher response rates, reduced need for phlebotomy & improvement in fatigue as measured by PROMIS Fatigue Short Form 8a The VERIFY…

ByRidhi RastogiAugust 31, 2026

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SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

Shots: The US FDA has granted Fast Track Designation (FTD) to SOT106 for the treatment of soft tissue sarcoma SOT106 is an ADC that targets LRRC15, a clinically validated target broadly expressed across multiple prevalent sarcoma subtypes, & has received FDA Orphan Drug Designation for osteosarcoma treatment SOTIO plans to initiate a first-in-human clinical trial of SOT106…

ByRidhi RastogiAugust 28, 2026

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Daiichi Sankyo Doses First Patient in the P-I Trial with DS1025 for Advanced Solid Tumors

Shots: Daiichi Sankyo has dosed the first patient in the P-I trial with DS1025 for the treatment of advanced or metastatic solid tumors with disease progression on or after ≥1 prior line of standard therapy The P-I trial of DS1025 will evaluate safety, tolerability, PK & preliminary efficacy above-mentioned pts (n=~45), assessing safety & tolerability,…

ByRidhi RastogiAugust 28, 2026

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Samsung Bioepis Begins P-I Trial of SB35 (Biosimilar, Taltz)

Shots: Samsung Bioepis Initiates Phase 1 Trial of SB35 (ixekizumab), a Biosimilar version of Taltz The P-I randomized, double-blind study will compare single-dose SB35 and Taltz in healthy participants for PK, safety, tolerability, and immunogenicity. Participants will be randomized 1:1, with 1EP including AUCinf, Cmax, and AUClast through Day 85 Ixekizumab is a humanized IgG4 mAb that selectively binds to IL-17A, blocking IL-17 receptor signaling and reducing…

ByRidhi RastogiAugust 28, 2026

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Formosa Pharmaceuticals Submits a CTA for TSY-110 (Biosimilar, Kadcyla)

Shots: Formosa has submitted a CTA to European regulatory authorities for a pivotal trial of TSY-110 (ado-trastuzumab emtansine), a biosimilar Version of Roche’s Kadcyla for HER2-positive breast cancer The trial will evaluate TSY-110’s safety, tolerability, PK, and immunogenicity versus the reference product; preclinical data show high biosimilarity, consistent DAR, and comparable plasma kinetics TSY-110 (EG12043) is an ADC biosimilar…

ByRidhi RastogiAugust 28, 2026

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The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

Shots: The FDA has accepted NDA for NCX 470 (bimatoprost grenod) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension (PDUFA: Apr 30, 2027) The NDA, submitted by US licensee Kowa, is supported by P-III (Mont Blanc & Denali) trial data showing IOP reductions of up to 10mmHg with a favorable safety…

ByRidhi RastogiAugust 28, 2026

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Natera and Angiex Partner to Monitor AGX101 Response Using Signatera

Shots: Natera has entered into collaboration with Angiex to use longitudinal Signatera testingfor circulating tumor DNA (ctDNA) to assess treatment response monitoring during AGX101 treatment AGX101 is designed to target TM4SF1-expressing tumor cells & tumor-associated endothelial cells, delivering a cytotoxic payload to both the tumor & its vasculature Angiex is conducting a P-I trial of…

ByRidhi RastogiAugust 28, 2026

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HighLife Receives CE Mark Approval for Clarity Valve for Use with the HighLife TMVR System

Shots: HighLife received CE Mark approval for its HighLife Clarity Mitral Heart Valve for use with HighLife TMVR System for adults with symptomatic mod. to sev. or sev. mitral valve regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair Four-year follow-up of the first 35 consecutively treated pts showed durable valve performance, with…

ByRidhi RastogiAugust 28, 2026

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The US FDA Approves ViiV Healthcare’s Tivicay PD for Young Children with HIV-1

Shots: The US FDA has approved Tivicay PD (dolutegravir) in combination with other antiretrovirals for HIV-1 treatment in pediatric pts weighing ≥2kg, incl. treatment-naïve or experienced pts who have not previously received an INSTI The FDA decision follows Priority Review & is supported by data from the NIH-funded IMPAACT 2023 study & pediatric PK modeling.…

ByRidhi RastogiAugust 28, 2026

Ridhi Rastogi

DualityBio Inks $1B+ Deal with Genentech to Develop Next-Generation ADCs

Takeda Reports the US FDA Approval of Mimrylo (Rusfertide) for Polycythemia Vera

SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

Daiichi Sankyo Doses First Patient in the P-I Trial with DS1025 for Advanced Solid Tumors

Samsung Bioepis Begins P-I Trial of SB35 (Biosimilar, Taltz)

Formosa Pharmaceuticals Submits a CTA for TSY-110 (Biosimilar, Kadcyla)

The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

Natera and Angiex Partner to Monitor AGX101 Response Using Signatera

HighLife Receives CE Mark Approval for Clarity Valve for Use with the HighLife TMVR System

The US FDA Approves ViiV Healthcare’s Tivicay PD for Young Children with HIV-1

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