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Tag: Phase 3 trial

Clinical Trials / North America

FDA Rejects Athenex’s Breast Cancer Treatment, Recommends Another Clinical Trial

2021-03-02 - by Daniel Ojeda - Leave a Comment

On March 1st, New York-based Athenex Oncology, a global pharmaceutical company, announced receiving a complete response letter (CRL) from the FDA for its Encequidar. The agency expressed concern about the …

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AstraZeneca's Imfinzi fails in Phase 3 Head and Neck Cancer Trial
Clinical Trials / Industry News

AZ’s Immune Checkpoint Inhibitor Flunks Head and Neck Cancer Trial

2021-02-09 - by Eduardo Longoria - Leave a Comment

On February 5th, AstraZeneca announced that the KESTREL Phase 3 trial, which evaluated its PD-L1 antibody, failed to deliver desired results. Imfinzi (durvalumab) did not meet the primary endpoint of improving …

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COVID-19 / Feature

Johnson & Johnson’s COVID-19 Vaccine Draws Mixed Reactions as it Registers 66% Efficacy

2021-01-302021-02-03 - by Daniel Ojeda - Leave a Comment

On January 29th, Johnson & Johnson announced results from the Phase 3 clinical trial of its COVID-19 vaccine candidate. Results show the vaccine is 85% effective at preventing severe disease. …

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North America

FDA Approves Second Lupus Nephritis Drug in Two Months

2021-01-25 - by Rajaneesh K. Gopinath - Leave a Comment

Just a month after approving GSK’s Benlysta (belimumab), the FDA has now approved a second drug for treating lupus nephritis. On January 22nd, Candian biotech Aurinia Pharmaceuticals Inc. bagged the …

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Asia Insight / Clinical Trials

Lynparza Bags Multiple Approvals in Japan

2021-01-042021-01-05 - by GeneOnline - Leave a Comment

On December 28th, Merck and AstraZeneca announced that their PARP inhibitor Lynparza received approval from Japan to treat ovarian, prostate, and pancreatic cancers. The approvals by the Japanese Ministry of Health, …

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Clinical Trials / Industry News

Amgen and AstraZeneca’s Asthma Drug Flunks Phase 3 Trial

2020-12-26 - by GeneOnline - Leave a Comment

Amgen and AstraZeneca’s asthma candidate tezepelumab has just failed a critical Phase 3 clinical trial. On December 22nd, the companies announced that their drug did not satisfy the main goal …

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Clinical Trials / North America

Spotlight: Novartis’ Kisqali Shows Promising Results in Metastatic Breast Cancer

2020-12-18 - by GeneOnline - Leave a Comment

On December 9th, Novartis announced encouraging updates from its Phase III clinical trial, MONALEESA-7, at the San Antonio breast cancer virtual symposium. The trial demonstrated that the CDK4/6 inhibitor Kisqali …

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Industry News

Agios Pharmaceuticals’ Lead Candidate Mitapivat Achieves Primary Endpoint in ACTIVATE Trial

2020-12-032020-12-03 - by GeneOnline - Leave a Comment

Agios Pharmaceuticals announced positive results of the ACTIVATE Phase 3 trial that evaluated its lead candidate Mitapivat. The experimental drug succeeded in the first of two Phase 3 trials to …

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Clinical Trials / North America

FDA Requests Additional Info for Liquidia’s Pulmonary Arterial Hypertension Treatment

2020-11-26 - by GeneOnline - Leave a Comment

On November 25th, Liquidia Technologies, a company focused on designing drug particles to ensure optimal delivery of therapeutics, announced that the FDA had given a complete response letter (CRL) for …

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Clinical Trials / Industry News

uniQure’s Gene Therapy Impresses in Pivotal Trial Raising Hopes of a Hemophilia B Cure

2020-11-22 - by GeneOnline - Leave a Comment

Hemophilia B is predominantly an inherited bleeding disorder characterized by the genetic deficiency of essential clotting factor IX (FIX). In healthy individuals, bleeding is controlled by the activation of a …

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