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Evogene and Shanghai Lishan Biopharmaceuticals Partner for BMC128

Shots: Biomica (Evogene’s subsidiary) & Shanghai Lishan Biopharmaceuticals have entered into an exclusive worldwide licensing agreement for BMC128, currently in P-I trial As per the deal, Lishan Biotech will receive exclusive rights to develop, manufacture, & commercialize BMC128, with Biomica receiving development milestone payments & royalties on future commercial sales Lishan Biotech is planning to…

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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…

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ONWARD Medical First Patient in Empower BP Study of ARC-IM System to Treat Blood Pressure Instability in Spinal Cord Injury

Shots: ONWARD Medical has enrolled the first patient in its Empower BP study evaluating ARC-IM System for symptomatic blood pressure instability in patients with chronic spinal cord injury The global trial will assess ARC-IM System against a sham in pts with C2–T6 spinal cord injuries & injury severities of AIS A-D across ~20 centers in…

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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…

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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,…

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