Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021

– Trial met both primary endpoints demonstrating statistically significant and clinically meaningful extension of progression free survival (PFS) as monotherapy vs. standard of care (SoC) endocrine therapy in overall population and estrogen receptor mutation (mESR1) population – In the overall population, elacestrant reduced risk of progression or death by 30% vs. SoC – In the mESR1 population, […]

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13 ธ.ค. 64

RedHill Biopharma Reports that Opaganib Mechanism Not Impacted by Viral Spike-Protein Mutations, Including Omicron Mutations

Unique Mode of Action Opaganib works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations, providing a strong rationale for its potential to address the Omicron SARS-CoV-2 variant, as well as other variants of concern Regulatory update Opaganib global Phase 2/3 […]

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9 ธ.ค. 64

Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for a Novel Glucagon-Like Peptide-1 Analogue, GZR18

Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the company’s compound, GZR18, to improve the management of type 2 diabetes mellitus. The investigational compound, GZR18, is […]

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8 ธ.ค. 64

Odyssey Announces Agreement to Combine with BenevolentAI

BenevolentAI is a leading, clinical-stage AI drug discovery company that combines advanced AI and machine learning with cutting edge science to discover and develop novel and more effective medicines Combination of BenevolentAI with Odyssey, a €300m Euronext Amsterdam-listed special purpose acquisition company focused on European healthcare and technology, represents the largest European SPAC merger to […]

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7 ธ.ค. 64

RedHill Biopharma Reports Operational Highlights and Third Quarter 2021 Financial Results

RedHill Accelerates its Two Advanced COVID-19 Pill Clinical Programs in Light of their Potential Against Omicron Acting independently of spike protein mutation, opaganib and RHB-107’s unique host-targeted mechanisms of action hold potential versus Omicron and other variants – Phase 2/3 study sub-population analysis demonstrated a 62% reduction in mortality in moderately severe hospitalized patients; Data packages […]

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3 ธ.ค. 64

Sai Life Sciences’ pharmaceutical API manufacturing site receives Certificate of Inspection from PMDA, Japan

Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organization (CRO/ CDMO), today announced that the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA) completed a paper-based compliance inspection of its intermediate & API manufacturing facility in Bidar, India and issued a Certificate of Inspection. Previously, the agency had conducted a three-day long physical audit in…

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2 ธ.ค. 64

GenScript and BioComo Join Forces to Accelerate Novel Intranasal SARS-CoV-2 Vaccine Development in Japan

GenScript Biotech Corporation (“GenScript”, Stock Code: 1548.HK), a leading global biotechnology company, and BioComo Incorporation, a drug discovery venture based in Mie prefecture, Japan, today announces a strategic agreement for joint research and development project on GenScript’s cPass™ SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit as the in vitro neutralization assay of a BC-PIV derived SARS-Cov-2 […]

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1 ธ.ค. 64
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