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.
The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.
Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.
Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
Will biosimilars share a compendial identity like generic drugs do?
Peer-reviewed papers and technical articles can help advance bio/pharmaceutical development.
The directorate highlights achievements accomplished during the year of its 50th anniversary.
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.
PTSM: Pharmaceutical Technology Sourcing and Management
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.
PTSM: Pharmaceutical Technology Sourcing and Management
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.
PTSM: Pharmaceutical Technology Sourcing and Management
Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.
PTSM: Pharmaceutical Technology Sourcing and Management
The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.
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.
PTSM: Pharmaceutical Technology Sourcing and Management
This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.
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.