Featured Pharma Online Editorial
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Peeling Back The Layers Of Radiolabeled Peptide Production
6/12/2025
From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.
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A Road Map For Transitioning From A Research-Focused To Commercialization Mindset
6/3/2025
As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?
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Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations
6/2/2025
The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).
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Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services
5/22/2025
The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?
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The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials
5/12/2025
Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.
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From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
5/7/2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.
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8 Ways To Drive Resilience In Oncology Drug Supply Chains
5/2/2025
From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.
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PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand
4/24/2025
Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
4/17/2025
The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.