Category Regulatory

Neurocrine Biosciences Launches C@H?! Initiative for Congenital Adrenal Hyperplasia Support

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has unveiled the launch of WHAT THE C@H?!, an educational initiative designed to address the information gap surrounding congenital adrenal hyperplasia (CAH) and acknowledge the challenges faced by the community in managing this condition. “We…

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CVS Health Allocates $19.2 Million Towards Affordable Housing in Arvada, Colorado

CVS Health® (NYSE: CVS) revealed today a significant investment of $19.2 million, facilitated via Boston Financial, earmarked for the construction of 85 new affordable housing units in Arvada, Colorado. This initiative, executed in partnership with Family Tree and BlueLine Development,…

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European Commission Clears Pfizer’s EMBLAVEO® for Multidrug-Resistant Infections

Pfizer Inc. (NYSE: PFE) has received approval from the European Commission (EC) for EMBLAVEO® (aztreonam-avibactam), expanding treatment options for adult patients facing complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including…

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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…

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