Pharmaceutical Technology Editors

Machine manufacturer IMA is showcasing a number of technological advances for the processing and packaging of pharmaceutical products at ACHEMA 2015.

The Hapa 862, from Hapa AG, is a modular, CMYK/spot-color inkjet printing system for the in-line packaging printing of foils and labels.

AmpliPhi announces that its new facility in Slovenia has received cGMP certification to manufacture bacteriophages for clinical trials.

The pediatric investigation plan provides a clinical development plan for Viaskin Peanut in pediatric population. DBV Technologies will now be able to submit a marketing authorization application in Europe following completion of the Viaskin Peanut Phase III trials.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.

BIO announces that for the second year in a row, it will feature the Innovation Zone at its 2015 conference in Philadelphia, PA.

A new demonstration facility in New York gives Sartorius’ customers hands-on access to bioprocessing systems and lab instruments.

EMD Millipore debuts a new cell-culture media compacting technology that will turn messy, dry powders into granules.

Teva announces the exclusive launch of its generic equivalent of Actonel in the US.

ProMetic Life Sciences will use manufacturing and plasma fractionation processes at Emergent BioSolutions’ Winnipeg, Canada facility.

The IPEC-Americas Foundation is accepting applications for graduate student, research, and industry research achievement awards.

Clinical supplies facility in Frankfurt, Germany will triple Theorem Clinical Research’s current clinical supplies capacity.

Excipient manufacturing site achieves EXCiPACT certification following regulatory inspections.

Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or biopolar I disorder.

New guidance complements ICH guidelines on impurities.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.

Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.

EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.