Drug Development

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

Articles

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.

CPI to Showcase Results of Biologic Drug Development Collaboration

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

Lonza Expands HPAPI Capacity

The Michelson Medical Research Foundation and the Human Vaccines Project have awarded three young scientists $150,000 for their novel approaches toward human immune system research.

2019 Michelson Prize Winners Announced

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

Formulation and Drug Delivery