Featured Pharma Online Editorial
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9 Pharma Trends To Watch In 2026
2/27/2026
What does 2026 ultimately hold for the industry? To explore that question, Lawrence Blatt, CEO of Aligos Therapeutics, sat down with me to share his perspective on the trends shaping the year ahead.
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U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
2/18/2026
Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
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FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
12/11/2025
The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.
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The 3 Big Barriers To AMT Implementation
7/18/2025
Advanced manufacturing technologies (AMTs) can not only lower costs but also improve the quality and consistency of both API and final dosage manufacturing in pharmaceuticals, so why are they not more widely implemented?
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Can AMTs Make U.S. Pharmaceuticals Faster, Better, Stronger?
7/11/2025
As the pharmaceutical industry prepares for impending tariffs and invests in domestic manufacturing, advanced manufacturing technologies present a viable opportunity to modernize systems for improved efficiency, consistent quality and potentially lower costs.
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Managing Extractables And Leachables In HPAPI Manufacturing
7/10/2025
These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.
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Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
6/16/2025
CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.
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Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
6/6/2025
This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.
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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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Small Molecule Pharma Companies Are Employing These Advanced Technologies To Get Ahead
5/19/2025
Small molecule drug companies are employing these concrete innovations, including several associated with Pharma 4.0, all boosting quality and efficiency.