BioPharm International Editors

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.

Bristol-Myers Squibb builds R&D facilities in Massachusetts and San Francisco and discontinues discovery research in virology.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

apceth has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG).

BioSC Lab is the first in a line of next-generation chromatography equipment for protein purification in batch and continuous modes.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

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.

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.

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.

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 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.

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

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