Featured Pharma Online Editorial
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Challenges And Solutions In Aseptic Evolution
4/22/2026
Aseptic processing has undergone a considerable evolution over the past 35 years in new equipment, standards, procedures, training and regulation. Navigating these challenges is essential to minimizing risk.
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U.S. Pharma Tariffs And MFN Become Law After April 2 Update
4/15/2026
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
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Lilly's Toolbox For Fast Track Fill Finish Sites
4/1/2026
Constructing greenfield fill finish sites is always a complex task, but throw in there the added challenge of delivering the site expediently, and the task becomes increasingly complicated.
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Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
3/17/2026
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
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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.