News

GlaxoSmithKline plans to invest nearly $41 million to expand its operations at its facility in Montrose, the United Kingdom.

Thermo Fisher must divest of cell culture media and sera lines, and other businesses, in purchase of Life Technologies.

Catalent opens clinical-trial supply facility in Shanghai, China.

Mylan and the Indian biopharmaceutical company Biocon receive approval for a biosimilar version of trastuzumab in India. Also, Mylan and Teva reach settlement on Copaxone in the EU.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

Merck KGaA plans to build a new biomanufacturing facility in Nantong, China.

Catalent has signed a product development agreement with immunology company Pure MHC (major histocompatibility complex), which specializes in MHC-based diagnostics and therapeutics.

Phase I/II study to evaluate treatment of patients with melanoma using Pfizer’s palbociclib and GSK’s trametinib.

Annual growth in spending for medicines is expected to rise from 2-3% in 2013 to 5-7% in 2017, the highest pace of growth since 2009.

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing based biosafety assessments to detect and identify viral contaminants within biologic compounds.

USP issues call for candidates for its 2015-2020 Council of Experts.

Ei Lilly announces investments in insulin manufacturing capacity for its sites in Indianapolis, Puerto Rico, France, and China.

Shire's agreement to acquire ViroPharma will strengthen its rare-disease portfolio.

AstraZeneca will build a new facility in the United Kingdom to produce Zoladex, an injectable prostrate cancer treatment.

Lyra Myers, associate director and value creation agent at Roche, has been elected DCAT president.

Grifols expands and diversifies portfolio with acquisition of diagnostic business.

Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.

ISPE names Novartis' US Flu Cell Culture facility as award winner.

ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.

FDA releases guidance on pulmonary tuberculosis drugs.

Allegations include off-label marketing for Risperdal, Invega and Natrecor and kickbacks to doctors and pharmacists.

DSM Pharmaceutical signs manufacturing agreements with Opthea and Sanquin.

Repligen completes expansion of its manufacturing facilities at its Massachusetts headquarters.

Pfenex receives subcontract from Leidos to develop a production process for the malaria antigen Plasmodium falciparum reticulocyte-binding homolog 5 (Rh5).

KaloBios Pharmaceuticals receives FDA Orphan Drug Designation for KB001-A in treatment of cystic fibrosis patients.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

A new report details FDA's role and responsibilities in personalized medicine.

Jeremy Levin, CEO and president of Teva Pharmaceutical Industries steps down , and interim successor named.