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Alvotech Reveals PK Data on AVT80 (Biosimilar, Entyvio)
Shots: Alvotech reported positive top-line data from the AVT80-GL-P01 PK study comparing AVT80 with Entyvio in healthy adults The study met all 1EP, demonstrating PK similarity between AVT80 & Entyvio following a single 108mg/0.68mL SC dose, supporting AVT80’s biosimilar profile Alvotech is developing AVT16 (IV) & AVT80 (SC) as Entyvio’s biosimilars, with the AVT80-GL-P01 study…
February 5, 2026
ZipBio and MeiraGTx Partner to Advance AAV Gene Therapy for Geographic Atrophy
Shots: ZipBio has entered into an exclusive license agreement with MeiraGTx, granting MeiraGTx exclusive right to AAV gene therapy to treat Geographic Atrophy Licensing deal will combine MeiraGTx’s expertise in vector design, clinical development, & in-house genetic medicine manufacturing with ZipBio’s de novo protein therapeutics created using its COMPACT generative AI platform As per the…
February 4, 2026
Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer
Shots: The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity…
February 4, 2026
Saya Biologics and Kashiv BioSciences Partner to Introduce a Biosimilar Supportive Oncology Therapy in Mexico and the CAC Region 
Shots:  Saya Biologics has signed a strategic partnership with Kashiv BioSciences to register and commercialize a supportive oncology therapy in Mexico and the CAC region  As per the deal, the agreement spans 11 countries across Mexico and the CAC region. Saya Biologics will handle regulatory registration, commercialization, and distribution, while Kashiv BioSciences will oversee manufacturing and supply.   Saya has already submitted the regulatory dossier in Mexico,…
February 4, 2026
Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease
Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…
February 4, 2026
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