Manufacturing, Biologic Drugs

Special Considerations for Extractables and Leachables Testing in Biological Products

February 02, 2015

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.

Ebola Treatments Ramp Up for Clinical Trials

January 23, 2015

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

FDA Approves 35 New Drugs in 2014

December 17, 2014

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

Baxter Enters Agreement to Sell Vero Cell Vaccines Platform

December 15, 2014

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

Legal Immunity Offered to Makers of Ebola Vaccines in the US

December 11, 2014

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

EMA Reassures Safety of Novartis Flu Vaccine

December 04, 2014

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

Dalton Receives Funding for Development of RSV and Parainfluenza Type 3 Vaccines

December 01, 2014

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

J&J Speeds Ebola Vaccine Development and Expands Production

October 24, 2014

Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an Ebola vaccine.

IDT Biologika Certifies Facility to Fill and Lyophilize Biologics and Vaccines

October 10, 2014

IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.

NIH Seeks to Improve Vaccine Response with New Adjuvants

September 30, 2014

NIH seeks new therapeutic products to bolster the protective properties of vaccines.