The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.
Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.
The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
More-and earlier-interaction between R&D and payers will be essential if innovative therapies are to become more accessible for patients, and more profitable for manufacturers, said panelists at the 2018 Galien Foundation Forum.
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.
Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.
AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.
Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.
The multi-year collaboration will incorporate NextCure's proprietary FIND-IO platform, a technology designed to identify novel cell-surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites.
The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.
The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.
Fujifilm Diosynth Biotechnologies and the Centre for Process Innovation (CPI) are collaborating to complete the technology transfer of the expression and purification of model monoclonal antibodies (mAbs) as part of AMECRYS, a research project funded by the European Commission.
Bioprocessing and manufacturing events bioLIVE and BioProduction Congress will take place as one event adjacent to CPhI Worldwide in Frankfurt, Germany, on November 5–7, 2019.
Cytek Biosciences’ Northern Lights series of advanced flow cytometry systems brings reagent and application flexibility to more labs while enhancing performance.
The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
Thermo Fisher Scientific has entered into a collaboration with Symphogen to deliver validated, platform workflows for simplified characterisation and quality monitoring of complex therapeutic proteins.
This new partnership provides access to Distributed Bio’s antibody discovery platforms.
New data highlights ability of the SQZ cell therapy platform to preserve cellular functions.
A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.
A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.
Kimberly-Clark Professional added the Kimtech A5 Sterile Integrated Hood and Mask XL for head shapes, sizes, and hairstyles that pose a challenge to standard aseptic gowning for cleanroom operators.
The acquisition will allow Lonza to further develop technology for scalable autologous cell-therapy manufacturing.
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
