Category Regulatory

Gepotidacin: Promising Oral Treatment for Uncomplicated Urogenital Gonorrhoea in Phase III Data

GSK plc (LSE/NYSE: GSK) has unveiled encouraging outcomes from the pivotal EAGLE-1 phase III trial concerning gepotidacin, a prospective first-in-class oral antibiotic offering a novel approach to combat uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. These findings are slated…

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Positive Outcomes in Giant Cell Arteritis Patients from Phase 3 SELECT-GCA Trial of Upadacitinib (RINVOQ®)

AbbVie (NYSE: ABBV) has announced encouraging findings from its Phase 3 trial, SELECT-GCA, showcasing positive top-line results. The trial, conducted across multiple centers, employed a randomized, double-blind, placebo-controlled design. It investigated the efficacy of upadacitinib (marketed as RINVOQ®) in combination…

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Cerevel Therapeutics Reports Favorable Topline Findings in Phase 3 Adjunctive Study of Tavapadon for Parkinson’s Disease Patients

Cerevel Therapeutics (Nasdaq: CERE) has released encouraging findings from its pivotal Phase 3 TEMPO-3 trial for tavapadon, a unique D1/D5 receptor partial agonist investigated as a once-daily treatment for Parkinson’s disease. This trial assessed tavapadon’s efficacy, safety, and tolerability as…

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Report on Results from ICMRA-WHO Workshop Addressing Strain Changes in COVID-19 Vaccines

Today, the joint effort of the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) culminated in the publication of a comprehensive report detailing the outcomes of their recent workshop on COVID-19 vaccine strain updates. Conducted…

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Alert: Falsified (Contaminated) USP/EP Propylene Glycol – Medical Product Alert N°1/2024

Alert Overview This alert from the World Health Organization (WHO) addresses the discovery of falsified DOW USP/EP Propylene Glycol in Pakistan. Authentic DOW USP/EP Propylene Glycol is a crucial raw material used in pharmaceutical and other manufacturing processes, meeting the…

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Novartis’ Fabhalta® (iptacopan) reduces proteinuria by 38.3% in IgA Nephropathy Patients

Novartis recently shared promising findings from the Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan), a Factor B inhibitor targeting the alternative complement pathway, in patients with IgA nephropathy (IgAN). In this interim analysis, patients treated with Fabhalta experienced a significant…

Read MoreNovartis’ Fabhalta® (iptacopan) reduces proteinuria by 38.3% in IgA Nephropathy Patients

Agenus Reveals Latest Phase 1 Findings and Advances in BOT/BAL Development for Metastatic MSS Colorectal Cancer

Agenus Inc. (NASDAQ: AGEN), a renowned player in the realm of discovering and advancing novel immunological treatments for diverse cancers, has disclosed the latest outcomes from its Phase 1 clinical assessment of BOT/BAL combination therapy targeting patients with metastatic CRC…

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Pfizer Reveals Encouraging Phase 3 Findings of ABRYSVO® in High-Risk Adults (Ages 18-59) Vulnerable to RSV Disease

Pfizer Inc. (NYSE: PFE) has reported promising top-line data on the immunogenicity and safety of ABRYSVO® from its pivotal Phase 3 clinical trial MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness). The trial, registered under NCT05842967,…

Read MorePfizer Reveals Encouraging Phase 3 Findings of ABRYSVO® in High-Risk Adults (Ages 18-59) Vulnerable to RSV Disease