Manufacturing, Biologic Drugs

FDA Panel Votes Unanimously to Approve GSK Shingles Vaccine

September 14, 2017

Shingrix represents a new, possibly better alternative to existing treatments.

FDA Approves Novartis’ CAR-T Drug, First Gene Therapy Approval in US

August 30, 2017

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

BioPhorum Launches Biomanufacturing Technology Roadmap

July 24, 2017

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

Pricing Pressure Drives Down Drug Sales Forecasts

June 27, 2017

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

BiondVax Receives European Union Investment in Universal Flu Vaccine Development

June 22, 2017

A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.

Supreme Court Rules in Amgen v. Sandoz

June 12, 2017

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

MSD Announces EUR280 Million Investment in Ireland and 330 New Jobs

May 30, 2017

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.

PTSM: Pharmaceutical Technology Sourcing and Management