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Dr. Priya Nandakumar is a Clinical Trials Intelligence Editor for United States & Americas pharmaceutical intelligence editor on NovaPharmaNews, with 28 published articles covering FDA regulatory actions, clinical development, and market-moving news. Dr. Priya Nandakumar specializes in trial readouts and protocol strategy across immunology and rare disease programs. She has 12 years of experience translating complex endpoints into clear insights for pharma operators and investors.
About Dr. Priya Nandakumar
Dr. Priya Nandakumar specializes in trial readouts and protocol strategy across immunology and rare disease programs. She has 12 years of experience translating complex endpoints into clear insights for pharma operators and investors.
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Topics and beats Dr. covers across United States & Americas.
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Articles by Dr. Priya Nandakumar
Cellenkos Receives FDA Clearance for CK0802 Phase 2a Trial in Steroid-Refractory GVHD
Cellenkos gets FDA approval to test CK0802, a first-in-class regulatory T cell therapy for patients with steroid-refractory graft-versus-host disease.
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis and Blood Disorders
Incyte receives FDA approval for once-daily Jakafi XR (ruxolitinib) extended-release tablets for myelofibrosis, polycythemia vera, and GVHD treatment.
Purdue Pharma Shutdown: $7.4B Deal Ends OxyContin Maker's Operations
Purdue Pharma, the manufacturer of OxyContin, is ceasing operations following a $7.4 billion settlement agreement. This landmark deal aims to address the company's role in the opioid crisis and provide compensation to victims.
Axsome FDA Approval for Alzheimer's Agitation Drug
Axsome Therapeutics has received FDA approval for a new treatment for agitation associated with Alzheimer's disease. This landmark decision addresses a critical unmet need and marks a significant step forward for the company and Alzheimer's patient care.
Edwards Lifesciences RESILIA Tissue Shows 10-Year Durability in Pivotal Aortic Valve Trial
Edwards Lifesciences announces 10-year COMMENCE trial results demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.
Orchard Therapeutics OTL-201: Innovation Passport for MPS-IIIA
Orchard Therapeutics has secured an Innovation Passport designation from the MHRA for its investigational gene therapy, OTL-201, targeting MPS-IIIA. This marks a significant step in accelerating development and access for patients with Sanfilippo syndrome type A.
ANVISA Clinical Trial Regulations: What Foreign Pharma Must Know in 2025
Learn essential insights on ANVISA's clinical trial regulations for 2025, crucial for foreign pharmaceutical companies navigating drug approvals in Brazil.
Neurocrine Biosciences CRENESSITY Shows Sustained Benefits in Two-Year Pediatric CAH Study
CRENESSITY (crinecerfont) demonstrates durable hormone control and reduced glucocorticoid exposure in pediatric congenital adrenal hyperplasia patients.
RedHill's RHB-204 Shows Comparable Efficacy to RHB-104 in Crohn's Disease MAP Treatment Development
RedHill's next-generation RHB-204 demonstrates comparable MAP-killing efficacy to RHB-104, advancing development for Crohn's disease treatment.
Summit Therapeutics Ivonescimab Shows Overall Survival Benefit in Lung Cancer, ASCO 2026 Plenary Data Expected
Summit Therapeutics reports overall survival data for ivonescimab in first-line squamous NSCLC will be featured at ASCO 2026 plenary session as late-breaking abstract.
Biosimilar Approval Pathways: ANVISA vs COFEPRIS Insights 2026
This article delves into the 2026 biosimilar approval pathways of ANVISA and COFEPRIS, focusing on their implications for monoclonal antibody therapies.
Relay Therapeutics Q1 2026 Earnings: Zovegalisib PI3Kα Inhibitor Updates Expected May 5
Relay Therapeutics announces Q1 2026 financial results May 5, featuring updates on zovegalisib, the first pan-mutant selective PI3Kα inhibitor for cancer treatment.
Neurocrine Biosciences INGREZZA Shows Clinically Meaningful Improvement in Tardive Dyskinesia Study
New research establishes clinically meaningful improvement threshold for INGREZZA (valbenazine) in tardive dyskinesia patients using TDIS scale.
FDA Accelerated Approvals Oncology: 2026 Policy Review & Zongertinib Case
This article delves into the FDA's 2026 policy review on accelerated approvals in oncology, focusing on the case of Zongertinib for lung cancer therapy.
Teva Reports Strong Q1 2026 Results as PONLIMSI Biosimilar Receives FDA Approval and Olanzapine LAI Advances
Teva's Q1 2026 earnings show strong performance driven by PONLIMSI biosimilar FDA approval and olanzapine LAI NDA acceptance for schizophrenia treatment.
Rein Therapeutics LTI-03 Phase 2 Trial Enrolls 8 Patients for Idiopathic Pulmonary Fibrosis Treatment
Rein Therapeutics reports 8 patients enrolled in Phase 2 RENEW study of LTI-03 for idiopathic pulmonary fibrosis across US, Australia, and Poland sites.
Cancer Care Centers of Excellence in GCC: Technology & Protocols Analysis
This article analyzes the latest technologies and treatment protocols at Cancer Care Centers of Excellence in the GCC, enhancing patient outcomes in oncology.
Biosimilars Growth in EU: Market Forecast Post-Biologics Patent Expiry
This article analyzes the anticipated growth of biosimilars in the EU following the patent expiry of major biologics, including Humira for rheumatoid arthritis.
InnoCare Pharma Begins Phase III Trial of Orelabrutinib for Systemic Lupus Erythematosus Treatment
InnoCare Pharma doses first patient in Phase III trial testing BTK inhibitor orelabrutinib for systemic lupus erythematosus, marking key milestone.
Vensica Medical Receives FDA IND Approval for Phase 2 Trial of ViXe Needle-Free Xeomin Delivery System
Vensica Medical gets FDA clearance to begin Phase 2 trials for ViXe, a needle-free delivery system for Xeomin treatment of overactive bladder syndrome.
NCCN Adds Nuvation Bio's Taletrectinib (IBTROZI) to Cancer Treatment Guidelines for ROS1-Positive NSCLC with Brain Metastases
NCCN includes Nuvation Bio's taletrectinib as recommended treatment option for ROS1-positive non-small cell lung cancer patients with brain metastases.
FDA Approval mRNA Vaccine RSV: Market Impact & Future Outlook
The FDA's approval of the mRNA vaccine for RSV marks a significant advancement in respiratory syncytial virus prevention, with profound market implications and future potential.
FDA Approves Regeneron's Otarmeni: First Gene Therapy for Genetic Hearing Loss Shows 80% Success Rate
Regeneron's Otarmeni becomes first FDA-approved gene therapy for OTOF-related hearing loss, with 80% of patients meeting primary endpoint and 42% achieving normal hearing.
SAHPRA Expedited Review Pathways: Accelerating Novel HIV Therapy Access in 2025
SAHPRA's expedited review pathways aim to accelerate access to innovative HIV therapies in 2025, improving treatment options for patients worldwide.
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