News & Updates
COVAXIN™ whole virus inactivated vaccine generated broad antibody response comparable to those seen in a large phase 3 trial in adults 18+ Adverse events were primarily mild, and no serious adverse events (SAEs) were noted Immunobridging trial demonstrated safety, reactogenicity and immunogenicity of COVAXIN™ in children from 2 years old and up No cases of myocarditis or…
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Two 45 μg doses and single 90 μg of protein subunit vaccine AKS-452 were generally well-tolerated and showed robust neutralizing antibody titers Primary immunogenicity endpoints were met Vaccine is shelf stable for at least 6 months at 25° C (77° F) Phase II/III trial starting in India Excerpt from the Press Release: BEVERLY, Mass.–(BUSINESS WIRE)–Akston…
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Excerpt from the Press Release: SAN RAFAEL, Calif. and SHANGHAI, Dec. 16, 2021 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Skyline Therapeutics (formerly Geneception), a gene and cell therapy company focused on developing novel treatments for unmet medical needs, today announced a multi-year global strategic collaboration for the discovery, development and commercialization of Adeno-Associated…
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Excerpt from the Press Release: SAN CARLOS, Calif.–(BUSINESS WIRE)–Glycomine, Inc., a biotechnology company focused on developing new therapies for orphan diseases, today announced that the company has received U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for GLM101 for the treatment of PMM2-CDG and has initiated dosing healthy volunteers…
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Excerpt from the Press Release: PALO ALTO, Calif., Dec. 17, 2021 (GLOBE NEWSWIRE) — Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that the first patient has been dosed in the Company’s Phase 1 dose-escalation study of VIP152 in…
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– Study to Inform Phase 3 Program Design of AD109 and Advance Program for AD504 – Topline Results Expected Mid-2022 Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced the dosing of the first patient in the…
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– Independent Data Monitoring Committee recommends proceeding with two additional planned patient cohorts, which are now being recruited in parallel – Positive safety profile, including no serious adverse events, no complications related to intra-cisterna magna injection and no evidence of dorsal root ganglion toxicity – Intra-cisterna magna delivery resulted in substantial increases in beta-galactosidase enzyme…
Read More Only antibody authorized in the US for pre-exposure prophylaxis of COVID-19 Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s EVUSHELD (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data. In this study,EVUSHELD’s Inhibitory Concentration 50 (IC50), a measure…
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-Studies demonstrate high correlation between predicted response by Notable’s predictive precision medicines platform and actual clinical response, short-term and at one year- -Interim analyses of studies with MD Anderson Cancer Center and Texas Children’s Hospital investigators corroborate platform prediction data from Standford University collaboration- Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Notable Labs, Inc.…
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Cross-reactivity will be assessed using samples from Phase II clinical participants and in a parallel animal challenge study Oral tablet’s immunogenicity profile suggests it may provide cross-protection against SARS-CoV-2 variants, including Omicron Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc. (NASDAQ: VXRT) said today it plans to…
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