News

The decision makes Australia the first and only nation to permit automatic substitution of biosimilars.

A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results-and costs-of popular cancer medications.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

Pharmaceutical Technology spoke with Monica Caphart, FDA, and Susan Schniepp, PDA, about the 2015 PDA/FDA Joint Regulatory Conference taking place in Washington, DC, in September.

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.

If adopted, open innovation, beyond outsourcing and licensing, could boost biopharm pipelines four-fold, a recent Deloitte study suggests.

The agency takes action against websites that illegally sell unapproved medications.

The International Conference on Harmonization finalizes Q&A document on APIs.

Biomax Informatics AG and Pierre Fabre announced that they have entered into a collaboration to create an integrated antibody sequence and knowledge database.

Lonza’s planned facility will be used to develop and manufacture viral gene therapies and virally modified cell therapies

EvaluatePharma report shows continued pharma and biotech sector confidence.

GSK announces it will invest $95 million to launch a US-based non-profit research institute, Altius, to research technologies and approaches in understanding gene control.

The agency streamlines risk and mitigation information.

A new SGS Life Science Services laboratory outside Paris is designed for bio/pharmaceutical quality control testing.

BioSC Lab biochromatography system performs protein purification in batch and continuous modes.

Dry media powder for the production of biotherapeutics and vaccines will be produced in a new facility in Scotland, in addition to an existing facility in New York.

Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.

The University of Pennsylvania announces that it will collaborate with WuXi AppTech to research and develop gene vectors derived from recombinant viruses.

The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.

The agency launches initiative to stimulate pediatric drug development.

A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.

CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

The supplier will add Allied Laboratories and AR Brown to its list of global partners.