Drug Development

Articles

The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.

Roundup of European Biosimilars Approved in 2018

Melanie Zerulla-Wernitz is team leader project & service analytics,Vetter Pharma-Fertigung GmbH & Co. KG.

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.


Analysis of Sub-Visible Particles

Pharmapack Europe event organizers have released a report titled, ‘European drug delivery and packaging’ that forecasts an increase in innovation from smaller European companies.

Pharmapack Report Forecasts a Rise in Innovation from Smaller Companies

ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.

ChargePoint Achieves HazLoc Certification, Allowing for North American Expansion

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Janssen, MeiraGTx Partner on Eye-Focused Gene Therapy

Valerie Theobald is director, immunoanalytical services at Charles River Laboratories. 

Jenifer Vija is scientific director, bioanalysis, at Charles River Laboratories.

Jessica St. Charles is director, laboratory sciences at Charles River Laboratories.

Christina Satterwhite, PhD, is senior director, global laboratory sciences at Charles River Laboratories. 

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

Emerging Therapies Test Existing Bioanalytical Methods

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs. 

FDA Looks to Advance Complex Generics

Merck & Co.’s V920 (rVSV-ZEBOV) vaccine is expected to pave the way for the development of vaccines for emerging infectious disease with unpredictable disease incidence or geography, according to data and analytics company, GlobalData.

Merck’s Experimental Vaccine Marks Turning Point in Ebola Outbreak Prevention

This injection formulation of USP-grade leucovorin calcium is now available in the United States.

Fresenius Kabi Launches Leucovorin Calcium Injection, USP

The US and pharmerging markets will drive growth in drug spending; number of approvals to increase.

Formulation and Drug Delivery