Drug Development

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Articles

FDA and USP take sides in debate on biologic drug standards. 

A Biologics Partisan Divide

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

The Wellcome Global Monitor has demonstrated an overall positive trust in science but some concerns still remain on attitudes on vaccines.


A Wellcome Result for Science

Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.


Selecting a Solid Approach

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

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

Facilitating API Delivery with Nanoscale Solutions

More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.

Macleods Issues Recall Due to NMBA Impurities

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

Catalent Biologics Acquires Vaccine Manufacturing Facilities

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

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics. 

FDA Challenges USP Standards for Biologics

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

FDA Approves Amgen and Allergan's Biosimilar to Herceptin

The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed. 

FDA Improves Transparency and Predictability for Generic Drug Applicants

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

Formulation and Drug Delivery