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The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta) 

Shots:  The US FDA has approved Armlupeg (pegfilgrastim-unne) as a biosimilar version of Neulasta (pegfilgrastim)   Armlupeg (6 mg/0.6 mL) is administered as a single-dose SC injection. It is indicated to reduce the incidence of febrile neutropenia in pts with non-myeloid cancers undergoing myelosuppressive CT and to improve survival following acute myelosuppressive radiation exposure   Armlupeg will be produced at Lupin’s Biotech facility…

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GSK and LTZ Therapeutics

GSK Collaborates with LTZ Therapeutics to Advance Myeloid Cell Engager Therapies in Oncology

Shots: GSK has entered into a strategic research collaboration with LTZ Therapeutics to advance the development of novel myeloid cell engagers (MCEs) in oncology, leveraging LTZ’s immune-engager platform Under the collaboration, GSK & LTZ aim to develop up to four MCE therapies for hematologic cancers & solid tumors, with GSK receiving an exclusive option to…

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Adagene Enters ~$845M Licensing Deal with Third Arc Bio to Develop Masked CD3 T Cell Engagers

Shots: Third Arc Bio has entered into a licensing agreement with Adagene to utilize its SAFEbody technology platform for generating masked CD3 T cell engagers against unique tumor-associated antigens As per the deal, Third Arc Bio will gain global rights to research, develop & commercialize 2 candidate molecules, while Adagene will receive a no-cost option…

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PharmaShots Magazine-November-2025 Edition

Radiopharmaceuticals, once viewed as a niche scientific endeavor, are now revolutionizing the way we detect and treat cancer. By fusing the targeting precision of molecular medicine with the therapeutic strength of radiation, these compounds are unlocking new possibilities in oncology, bringing renewed hope to patients where conventional therapies often fall short From early detection to…

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Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots: The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib) The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variants Also, clinical bridging studies…

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Hutchmed

HUTCHMED Completes Enrollment in Global P-III (SAFFRON) Study of Orpathys + Tagrisso in Lung Cancer Patients

Shots: HUTCHMED completed the pts enrollment in the global P-III (SAFFRON) study evaluating Orpathys (savolitinib) + Tagrisso (osimertinib) vs Pt. based doublet CT in pts with EGFR-mutated, MET-overexpressed, and/or amplified, LA/M NSCLC after progression on Tagrisso, with the last patient being randomized on 31 Oct’25 The Ongoing P-III (SAFFRON) study is evaluating the efficacy and…

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