Category Regulatory

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…

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

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…

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

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…

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

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…

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

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

Ionis Reveals Encouraging Findings from Phase 3 Balance Trial of Olezarsen in Familial Chylomicronemia Syndrome

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) has unveiled comprehensive findings from the Phase 3 Balance study of olezarsen, its leading independent investigational medication, targeted at adults grappling with familial chylomicronemia syndrome (FCS). The study revealed that the monthly administration of olezarsen…

Read MoreIonis Reveals Encouraging Findings from Phase 3 Balance Trial of Olezarsen in Familial Chylomicronemia Syndrome