
Enzyme replacement therapies for rare diseases and cancer treatments are recommended for approval.

Enzyme replacement therapies for rare diseases and cancer treatments are recommended for approval.

SGS Life Science Services expands cGMP chemistry and biotechnology testing facilities in Shanghai.

A 25,000-sq-ft cargo facility at Philadelphia International Airport offers different levels of temperature storage.

Bylo has been selected to lead the GS1 Healthcare US Industry Initiative, focused on driving adoption and usage of GS1 Standards in healthcare.

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

The European Medicines Verification Organization has signed agreements with service providers to establish blueprint systems in compliance with the Falsified Medicines Directive.

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

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

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

Juniper Pharma Services has entered into a long-term collaboration with OxSonics to support the development, scale-up, and GMP manufacturing of OxSonics’ proprietary sono-sensitive particles.

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.

Reach Separations has announced plans to double its laboratory space at its Nottingham facility as a result of increased demand for its specialist purification services.

The combined company has been created through the integration of Huntingdon Life Sciences and Harlan Laboratories announces a new company name.

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

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.

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

Kite announces that it will collaborate with bluebird bio to develop and commercialize second-generation T-cell receptor product candidates for HPV-associated cancers.

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

CPhI China and co-located events bring together suppliers of raw materials, ingredients, packaging solutions, machinery, and manufacturing.

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

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.

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.

EXCiPACT announces that DQS awarded Grace GmbH an EXCiPACT Certificate for its Worms, Germany excipient-manufacturing site.

The agency streamlines risk and mitigation information.

EvaluatePharma's report shows upward trends in R&D and drug approvals.