Industry News

SGS Life Science Services announced that its bioanalytical laboratory in Poitiers, France has received GMP certification, following approval from ANSM.

Almac releases an enhanced third-party logistics customer billing application.

GSK and Amicus Therapeutics revise Fabry agreement entered into in July 2012.

Coldstream Laboratories names director of formulation development.

Pure MHC and Catalent sign an agreement to develop RL21A using Catalent's GPEx technology.

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

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

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.

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

DSM Pharmaceuticals appoints a new business unit director of its DSM Biologics/BioSolutions businesses.

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.

DSM Pharmaceutical Products opens a cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia.

Hospira opens a new quality and analytical testing laboratory at its Rocky Mount, North Carolina plant.

Novartis files Citizen Petition with FDA to maintain naming policy for all biologics to help ensure patient safety.

WuXi PharmaTech has completed a cell culture capacity expansion, including two 2000 L disposable bioreactors.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.

Beckman Coulter Life Sciences combines its particle characterization business with the Hach Company particle counting business.

FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.

FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.

Novozymes Biopharma will collaborate with Almac to provide a combined service for drug development applications.

The FDA grants Cornerstone Pharmaceuticals orphan drug designation for CPI-613 for the treatment of myelodysplastic syndrome.

The US Pharmacopeial Convention posted for public comments on its revisions to the USP Medicare Model Guidelines, which are posted for a 30-day public comment period, beginning Oct. 1, 2013.

PhRMA reports 452 new medicines are in development for rare diseases, including genetic disorders, neurological conditions, infectious diseases, and autoimmune disorders.

Sartorius and BD Diagnostics plan to collaborate on ready-to-use, prefilled media products for microbiological applications.

Vetter is investing $100 million to expand filling capacity in Germany and the United States.