Dr. Yuna Park MD, MPH

Sun Pharma Organon Partnership to Expand Access to Key Medicines

Sun Pharma has announced a strategic partnership with Organon to commercialize five of Organon's established products across India. This collaboration aims to leverage Sun Pharma's extensive network to improve patient access to vital treatments.

FDA Scrutiny Post-Market Data: Impact on Pharma Investment Strategies

This article examines the implications of FDA scrutiny on post-market data and its influence on pharmaceutical investment strategies and drug development.

Decentralized Clinical Trials in LATAM: Growth, Challenges & Regulatory Insights

This article delves into the rise of decentralized clinical trials in LATAM, highlighting key growth factors, challenges faced, and essential regulatory insights.

Apotex Receives First Canadian Health Canada Approval for Generic Ozempic (Semaglutide) Alternative

Apotex becomes first Canadian pharmaceutical company to receive Health Canada approval for Apo-Semaglutide Injection, a generic equivalent of Ozempic.

EMA Conditional Marketing Authorization: Linvoseltamab for RRMM in EU

Linvoseltamab has received EMA's Conditional Marketing Authorization for treating relapsed/refractory multiple myeloma, offering new hope for patients in the EU.

Alzheimer's Clinical Trial Failures: Insights from Semaglutide & Posdinemab FDA Trials

This article delves into the recent failures of Alzheimer's clinical trials involving Semaglutide and Posdinemab, highlighting key insights and future directions.

Pandemic Trial Networks Repurposed: Africa’s COVID-19 Legacy in Clinical Research

This article examines the impact of Africa's COVID-19 pandemic trial networks on future clinical research, highlighting innovative strategies and drug development.

FDA Accelerated Approval Pathway: Impact on Oncology Drug Development & Market Access 2026

This article examines the FDA Accelerated Approval Pathway and its significant influence on the development and market access of oncology drugs by 2026.

ANVISA Risk-Based Inspection: What You Need to Know About Brazil's New Compliance System

Learn about Brazil's new compliance system, ANVISA's Risk-Based Inspection, and its impact on pharmaceutical safety and market access.

TGA Updates Comprehensive Regulatory Framework for Implantable Medical Devices in Australia

Australia's TGA provides updated guidance on implantable medical device regulations, covering manufacturing, application processes, and market authorization requirements.

Pembrolizumab Combinations Mexico: COFEPRIS Market Access & Clinical Insights

Discover the latest on Pembrolizumab combinations in Mexico, including COFEPRIS market access and vital clinical insights for enhanced cancer therapies.

BioMarin Completes $3 Billion Acquisition of Amicus Therapeutics, Expands Rare Disease Portfolio with Galafold and Pompe Therapies

BioMarin's acquisition of Amicus adds globally approved Galafold for Fabry disease and POMBILITI/OPFOLDA combination for Pompe disease to its rare disease pipeline.

WuXi Biologics Chengdu Microbial Manufacturing Site Reaches Structural Completion, Targets 2026 GMP Production

WuXi Biologics announces structural completion of its Chengdu microbial manufacturing facility with key equipment arrival, targeting GMP production by end 2026.

Daewoong Pharmaceutical NABOTA Master Class Highlights PrabotulinumtoxinA Safety for High-Dose Treatments

Daewoong Pharmaceutical hosted 74 healthcare professionals from 13 countries for NABOTA Master Class, emphasizing PrabotulinumtoxinA safety protocols.

Spinogenix Launches Phase 2b/3 CLARITY Trial of SPG601 for Fragile X Syndrome Treatment

Spinogenix initiates CLARITY Phase 2b/3 trial testing SPG601, a first-in-class oral therapy targeting BK channels for Fragile X Syndrome in male patients.

SFDA Acceptance of FDA Approvals: What You Need to Know

Discover how the SFDA's acceptance of FDA drug approvals impacts the availability of diabetes medications in your region and what it means for patients.

Treatment Sequencing in NSCLC: Insights from EU Guidelines and ESMO

This article delves into the latest EU guidelines and ESMO recommendations on treatment sequencing for non-small cell lung cancer (NSCLC), highlighting osimertinib's role.

Calluna Pharma Completes CAL101 Phase 2 Enrollment for Idiopathic Pulmonary Fibrosis Treatment

Calluna Pharma enrolls 161 patients in Phase 2 AURORA study of CAL101 for IPF treatment, six months ahead of schedule with topline data expected Q1 2027.

Alphamab Oncology JSKN016 TROP2/HER3 Bispecific ADC Shows Promise for HER2-Negative Breast Cancer at ASCO 2026

Alphamab Oncology presents clinical data for JSKN016, a novel TROP2/HER3 bispecific ADC targeting HER2-negative breast cancer at ASCO 2026 conference.

Duchesnay and PeriPharm Call for Regulatory Reform as Canadian Women Wait 3+ Years for Health Innovations

Duchesnay and PeriPharm publish joint study revealing Canadian women wait over three years to access new health treatments, calling for regulatory updates.

Australia's TGA Updates In Vitro Diagnostic Device Regulations for Medical Device Manufacturers

Australia's Therapeutic Goods Administration releases comprehensive guidance for in vitro diagnostic device manufacturing, applications, and market authorization.

Washington State Life Sciences Industry Leads National Growth for Fifth Consecutive Year, Contributing $24.4B to GDP

Washington's life sciences sector outpaces national growth for 5th year, contributing $24.4B to state GDP with third-largest AI specialist cluster in US.