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Dr. Grace Tan is a Senior Regulatory Intelligence Lead for Asia-Pacific Region pharmaceutical intelligence editor on NovaPharmaNews, with 23 published articles covering NMPA regulatory actions, clinical development, and market-moving news. Dr. Grace Tan provides senior analysis on regulatory convergence, inspection priorities, and quality compliance for APAC manufacturers. Her 19 years in regulatory operations make her a trusted voice on launch risk and remediation planning.
About Dr. Grace Tan
Dr. Grace Tan provides senior analysis on regulatory convergence, inspection priorities, and quality compliance for APAC manufacturers. Her 19 years in regulatory operations make her a trusted voice on launch risk and remediation planning.
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Topics and beats Dr. covers across Asia-Pacific Region.
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Articles by Dr. Grace Tan
SPONTAN Phase II Data Shows 10-Minute Onset Time, Meets FDA Requirements for Erectile Dysfunction Treatment
SPONTAN Phase II interim results demonstrate 10-minute median onset versus 60 minutes for oral vardenafil, meeting FDA pharmacokinetic requirements.
Purdue Pharma Dissolution Approved: What It Means for Opioid Crisis
Purdue Pharma, the maker of OxyContin, is set to dissolve after a judge approved its criminal sentence. This landmark decision is a significant development in the ongoing legal battles surrounding the opioid crisis.
FDA Approves First Non-Antipsychotic for Dementia Agitation
The FDA has approved the first non-antipsychotic medication for agitation linked to dementia from Alzheimer's disease. This landmark approval provides a much-needed alternative to antipsychotics, which carry significant risks for this patient population.
Local Pharmaceutical Manufacturing South Africa: SAHPRA Policy Impact 2025
This article examines the implications of SAHPRA's 2025 policies on local pharmaceutical manufacturing in South Africa, focusing on drug accessibility and innovation.
HIV Treatment Clinical Trials Africa: Long-Acting Injectables & AMA Pathways
This article delves into HIV treatment clinical trials in Africa, highlighting long-acting injectables and the AMA pathways for enhanced patient care.
Keenova Therapeutics Presents New TERLIVAZ Clinical Data for Hepatorenal Syndrome at Digestive Disease Week 2026
Keenova Therapeutics shares new TERLIVAZ (terlipressin) clinical analysis for hepatorenal syndrome-acute kidney injury at DDW 2026, expanding treatment evidence.
Verified Clinical Trials Partners with Chubb to Enhance Patient Safety and Data Quality in Clinical Research
Verified Clinical Trials and Chubb announce strategic alliance to improve clinical trial participant safety, data quality, and study integrity worldwide.
Genprex Receives Israel Patent for Reqorsa Gene Therapy Combined with PD-1 Antibodies in Cancer Treatment
Genprex secures Israeli patent protection for Reqorsa gene therapy combination with PD-1 antibodies, strengthening intellectual property portfolio for cancer treatment.
Bispecific Antibodies in Hematological Malignancies: Teclistamab, Mosunetuzumab & Epcoritamab FDA Review
This article delves into the FDA review of bispecific antibodies teclistamab, mosunetuzumab, and epcoritamab for hematological malignancies.
TLX597-Tx PSMA Radioligand Therapy Shows Promise in OPTIMAL-PSMA Trial for Early-Stage Prostate Cancer
TLX597-Tx radioligand therapy demonstrates low organ toxicity in OPTIMAL-PSMA trial, potentially enabling dose intensification for prostate cancer treatment.
EirGenix Expands Japan Biosimilar Strategy at CPHI Japan 2026 Amid Regulatory Support
EirGenix leverages Japan's supportive biosimilar regulatory framework and supply chain transformation to strengthen its strategic presence in the Japanese market.
SFDA Expedited Review Oncology Drugs: What You Need to Know
Learn about the SFDA's expedited review for oncology drugs, including Pembrolizumab, and how it impacts patient access to essential cancer treatments.
Alzheimer's Clinical Trial Failures: Impact on US Market & Investment
This article examines the implications of recent Alzheimer's clinical trial failures on the US market and investment trends, focusing on drugs such as Aducanumab.
Biosimilar Oncology Antibodies: EMA Market Dynamics & Healthcare Impact
This article delves into the market dynamics of biosimilar oncology antibodies, focusing on their role in cancer treatment and implications for healthcare systems.
Digital Health Solutions in MEA Oncology: Impact on Treatment Monitoring & Outcomes
Digital health solutions are revolutionizing oncology in the MEA region, improving treatment monitoring and patient outcomes, particularly with therapies like Keytruda.
Argo Biopharma Doses First Patient in Phase I Trial of siRNA Therapy BW-50218 for TTR-Related Disease
Argo Biopharma begins Phase I clinical trial of BW-50218, an siRNA therapeutic targeting transthyretin protein for rare disease treatment in Australia.
Jyong Biotech Advances Market Access Strategy for Botanical Drug Botreso® and PCP Pipeline
Jyong Biotech (NASDAQ: MENS) updates market access strategies for botanical drugs Botreso® and PCP, establishing competitive advantages in plant-derived therapeutics.
Automation Transforming Eco-Friendly Pharma Packaging
Explore how automation is revolutionizing sustainable pharmaceutical packaging. This article covers innovative systems, solutions, and supplier roles shaping eco-friendly packaging in pharma.
FDA Breakthrough Therapy Designations: Impact on Neurological Disorder Investments 2026
This article examines how FDA Breakthrough Therapy Designations are shaping investment trends in neurological disorders, focusing on drugs targeting Alzheimer's and Parkinson's.
FDA Labeling Changes for Oral Semaglutide: Cardiovascular Risk Insights
This article explores the recent FDA labeling updates for oral Semaglutide, focusing on new insights regarding cardiovascular risks associated with its use.
Sunnybrook Health Sciences Centre Receives $41 Million Investment to Expand Clinical Trials Infrastructure in Canada
Sunnybrook Health Sciences Centre announces $41M philanthropic investment to expand clinical trials capacity and strengthen Canada's position in global research.
Clinical Trial Data Sharing in Europe: EMA's New Open Science Mandate
The EMA's new Open Science mandate aims to improve clinical trial data sharing across Europe, fostering transparency and collaboration in drug development.
Fosun Health Wins Three Awards at GlobalHealth Asia-Pacific Forum 2026, Showcases China Solution Strategy
Fosun Health strengthened its regional presence at GlobalHealth Asia-Pacific Forum 2026, winning three major awards while showcasing its China Solution approach.
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