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Articles

The EMA’s annual report shows the agency approved 104 human drugs in 2025 that included first-in-class and first-in-indication therapies. 

EMA Approved 104 Human Medicines in 2025 

President and CEO, Klote Medical Research Advisors

Molly Klote, Klote Medical Research Advisors, discusses how pharma must move beyond tariff-driven reactions to build evidence-based, quality-led supply chain resilience that satisfies FDA scrutiny and protects patient access.

Q&A: Molly Klote on Dual Sourcing, Regionalization, and the New Pharma Normal

Nicholas Richardson is vice president of clinical development at Precision for Medicine.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients. 

Patient Access to Radiopharmaceuticals

The standards organization’s annual drug shortages report finds drug shortages lasting longer and the number of discontinuations rising, but the number of shortages themselves have gone down.

USP Reports Drug Discontinuations on the Rise

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Investigating Patient Complaints About Combination Products

Regulatory reform, patient access, and supply chain security were 3 of the key themes showcased this week on PharmTech.com.

PharmTech Weekly Roundup—June 5, 2026

Tom Sellig, Adare Pharma Solutions, shares how the CDMO is positioning for growth amid US reshoring and oral dose innovation trends.

Tom Sellig on CDMO Innovation and US Manufacturing Growth

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, not slogans, with quality built in.

Molly Klote on Reshoring, Tariffs, and the Future of Pharma Supply Chains

Kimberly Salgado is Head of Centre for Biosimilar Drug Development, ICON plc

Changes in regulations are reducing costs, expediting approval, and increasing the market for biosimilars.

Faster Doesn’t Mean Easier: Development Impacts of a New Biosimilar Regulatory Landscape

EMA, AMA, and national regulatory authorities in Africa are working on potential clinical trial designs and medical treatments for the Ebola outbreak in the DRC and Uganda.

Quality Systems