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Articles

Pierre Luzeau, CEO of Seqens, discusses Seqen's commitment to sustainability and how one can work toward it within their own company.

Setting Sustainability Goals with Pierre Luzeau (DCAT 2023)

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

US Supreme Court Weighs Biologics Patents in Amgen vs. Sanofi Case

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

FDA Approves First Over-the-Counter Naloxone Nasal Spray

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

Feds to Review March-In Authority on Drug Patents

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.

Never Mind the Statistics; Just Tell Me What the Answer Is! 

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation. 

First Drugs Hit by Inflation Reduction Act Price Controls

Mike Wilson, QA/QC Strategy, Waters Corporation

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

Mitigating Human Error and Supporting Compliance with Smart Technology

Paul Van Tilborg is director of analytical sciences at Ardena.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Phase-appropriate Analytical Methodology

David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon.

The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

How Banning Titanium Dioxide Might Impact Pharma

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

Quality Systems