Drug Development

Articles

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

A Survey of Postapproval CMC Changes to Generic Drugs

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

Report: Branded Biopharms Most Exposed to Biosimilar Competition

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

New methods of encapsulation and filtering address scale-up challenges.

Developments in Producing Microspheres

EMA releases an update on its flu vaccine guidance.

European Medicines Agency Updates Seasonal Flu Vaccine Guidance

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

Mylan Launches First Trastuzumab Biosimilar in India

BioOutsource will open a new Biosimilar Center of Excellence in Scotland.

BioOutsource To Open New Biosimilar Center of Excellence

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

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

FDA Focuses on Drug Appearance and Attributes

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

CMOs may find opportunities in alternative expression services.

Novel Expression Systems Opening CMO Opportunities

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

Pulmonary Drug Delivery—Particle Engineering for Inhaled Therapeutics

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Formulation and Drug Delivery