Month: March 2023

Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology

03/17/2023

Excerpt from the Press Release: MALVERN, Pa., March 10, 2023 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the presentation of a net treatment benefit analysis of Phase 3…

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InVivo Therapeutics Announces Topline Data from Pivotal INSPIRE 2.0 Study in Acute Spinal Cord Injury

03/16/2023

Study did not achieve primary endpoint of defined improvement on standard impairment scale InVivo to evaluate full data set and strategic options for the company Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord…

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Sermonix Pharmaceuticals Announces Initiation of Phase 3 ELAINE-3 Study of Lasofoxifene Plus Abemaciclib in Pre- and Post-Menopausal Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation as Detected by Guardant Health’s Guardant360 CDx Liquid Biopsy

03/15/2023

Excerpt from the Press Release: COLUMBUS, Ohio and PALO ALTO, Calif., March 09, 2023 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, and Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the initiation of…

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AusperBio Announces First-in-Human Dosing of AHB-137, an Antisense Oligonucleotide Drug Candidate for the Treatment of Chronic Hepatitis B

03/14/2023

Excerpt from the Press Release: SAN FRANCISCO, March 9, 2023 /PRNewswire/ — Ausper Biopharma Co., Ltd. and AusperBio Therapeutic, Inc. (Together AusperBio) today announced the completion of the first cohort dosing in a Phase 1 clinical trial evaluating AHB–137 in adult healthy volunteers and chronic hepatitis B (CHB) patients in New Zealand. AHB-137 is a…

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Praxis Precision Medicines Announces Topline Results from the Essential1 Study of Ulixacaltamide for the Treatment of Essential Tremor and Continued Advancement of Program to Phase 3

03/13/2023

Based upon observed efficacy and safety profile, Praxis intends to engage with the FDA in an end of Phase 2 meeting and initiate a ulixacaltamide Phase 3 study for the treatment of essential tremor in 2H23 Ulixacaltamide demonstrated improvement in modified Activities of Daily Living (mADL) primary efficacy endpoint relative to placebo that did not…

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IgGenix Demonstrated Potential for Single-Cell RNA-Sequencing to Address Shellfish Allergies at the 2023 AAAAI Annual Meeting

03/10/2023

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–IgGenix, Inc., a pre-clinical antibody discovery and development company taking a revolutionary approach to directly address allergic disease, recently presented insights into the potential for IgE antibody re-engineering in shellfish allergy. These data, generated using IgGenix’s novel patented SEQ SIFTER™ single-cell RNA-sequencing discovery platform, were presented…

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Triplebar and Umami Meats Initiate Technology Collaboration To Optimize Cell Lines for Sustainable Seafood

03/09/2023

Excerpt from the Press Release: EMERYVILLE, Calif. & SINGAPORE–(BUSINESS WIRE)–Biotechnology company Triplebar and cultivated seafood platform company Umami Meats are partnering to co-develop optimized cell lines suitable for large-scale production of cultivated seafood – starting with one of the most popular and critically endangered fish species. Emeryville, Calif.-based Triplebar and Singapore-headquartered Umami Meats signed a…

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Decisions, Decisions! 3 good questions to ask when considering new eClinical Technology.

03/08/2023

For 2023, we’re taking our blog in a new direction with more content directly from our team, more detailed information for our readers answering common questions we get, and helpful expert information and ideas you can use. We hope you enjoy this new approach. For this week, we’re covering an introduction (or refresher) to TrialStat…

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Intellia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NTLA-2002, an In Vivo CRISPR-Based Investigational Therapy for the Treatment of Hereditary Angioedema (HAE)

03/08/2023

NTLA-2002 is a single dose, in vivo genome editing candidate designed to prevent potentially life-threatening swelling attacks in people with HAE Excerpt from the Press Release: CAMBRIDGE, Mass., March 02, 2023 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced…

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Flamingo Therapeutics and Dynacure Announce Merger to Create Leading RNA Therapeutics Company Focused on Clinical Oncology

03/07/2023

-Combined company to be named Flamingo Therapeutics, focused on advancing Flamingo’s asset danvatirsen in a Phase II trial PEMDA-HN in Head & Neck cancer and IND-ready program targeting MALAT-1 (FTX-001), in oncology- -Merger leverages common synergies of Flamingo and Dynacure, including deep expertise in RNA-targeting and clinical drug development- Excerpt from the Press Release: LEUVEN,…

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