FDA

EVUSHELD™ significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations

04/29/2022

Pre-exposure prophylaxis (prevention) trial reduced risk of symptomatic COVID-19, with no severe disease or COVID-19-related deaths in EVUSHELD group Data published in the New England Journal of Medicine Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s EVUSHELD™(tixagevimab and cilgavimab), formerly AZD7442, reduced…

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Zambon Receives U.S. FDA Breakthrough Therapy Designation for CMS I-neb® in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFB)

04/27/2022

CMS I-neb® is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients with NCFB colonized with P. aeruginosa; NCFB is a chronic, progressive, and irreversible respiratory disease Breakthrough designation validates registrational path for CMS I-neb® in NCFB and facilitates potentially expedited development and review Excerpt from the Press Release: MILAN and BOSTON, April 21, 2022 /PRNewswire/ — Zambon, a…

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Proof Diagnostics Submits Request For Emergency Use Authorization Seeking First Approval Of Crispr-based Molecular Point-of-care Covid-19 Test

04/14/2022

If authorized by the FDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for COVID-19 (SARS-CoV-2) in as little as 18 minutes Excerpt from the Press Release: CAMBRIDGE, Mass., April 7, 2022 /PRNewswire/ — Proof Diagnostics, Inc., an innovative healthcare technology company delivering innovative solutions in molecular diagnostics, today announced the submission…

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Crinetics Pharmaceuticals Reports Positive Top-Line Results from CRN04777 Phase 1 Study Multiple-Ascending Dose Cohorts

04/08/2022

Results Further Support Clinical Proof-of-Concept for CRN04777 by Showing Dose-Dependent Decreases in Fasting and Sulfonylurea-Induced Insulin Secretion Management Hosting Webcast and Conference Call to Discuss Findings Today at 4:30 p.m. Eastern Time Excerpt from the Press Release: SAN DIEGO – March 30, 2022 – Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused…

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Concentric Analgesics Announces Positive Results from Pilot Phase 2 Clinical Trial of Vocacapsaicin in Open Laparotomy for Repair of Abdominal Ventral Hernia

04/07/2022

Data to be Presented at Upcoming Annual ASRA Meeting Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics, today announced positive results from its recently completed pilot Phase 2 clinical trial of vocacapsaicin in patients undergoing open laparotomy for ventral hernia…

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Genentech Provides Update on Phase III SKYSCRAPER-02 Study in Extensive-Stage Small Cell Lung Cancer

04/06/2022

SKYSCRAPER-02, the first randomized study of tiragolumab in extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival ES-SCLC is a hard-to-treat disease and Tecentriq plus chemotherapy remains a standard of care Tiragolumab continues to be evaluated in non-small cell lung cancer and other cancer types through additional Phase III…

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Prometheus Biosciences Initiates Third Phase 2 Study of PRA023 for Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

04/06/2022

– First therapeutic candidate for the treatment of SSc-ILD targeting both key fibrotic and inflammatory pathways – – ATHENA-SSc-ILD Phase 2 topline results expected first-half 2024 – – FDA has granted Fast Track Designation for PRA023 for the treatment of SSc-ILD – Excerpt from the Press Release: SAN DIEGO, March 30, 2022 (GLOBE NEWSWIRE) —…

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Eiger’s Single-dose Peginterferon Lambda for COVID-19 Reduced Risk of Hospitalization or ER Visits by 50% in a Predominantly Vaccinated Population in Phase 3 TOGETHER Study

03/25/2022

Second largest study to date in COVID-19 outpatients (N=1,936) Highly superior compared to placebo, with a probability of superiority of 99.91% on the primary endpoint 60% reduced risk of COVID-19-related death Primary endpoint achieved across multiple SARS-CoV-2 variants, including omicron Eiger plans to submit data to FDA for Emergency Use Authorization (EUA) Management to host…

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U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for EGFR Therapeutics Targeting Exon 19 Deletions or Exon 21 Substitutions in Non-Small Cell Lung Cancer

03/24/2022

Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as a companion diagnostic for a third group of targeted therapies Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, today announced it has received approval from the U.S. Food and Drug…

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Iovance Biotherapeutics’ Investigational New Drug Application (IND) Allowed to Proceed for TALEN®-Edited Tumor Infiltrating Lymphocyte (TIL) in Unresectable or Metastatic Melanoma and Stage III or IV Non-Small Cell Lung Cancer (NSCLC)

03/23/2022

Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression Excerpt from the Press Release: SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance…

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