Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
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Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.
Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
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FDA released draft guidance on using the USP pending monograph process in the drug application process.
Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.
The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.
Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.
New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.
Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.
Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.
Congress is weighing in on drug pricing with a range of measures that differ in style and substance.
GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.
The Michelson Medical Research Foundation and the Human Vaccines Project have awarded three young scientists $150,000 for their novel approaches toward human immune system research.
ABPI has published a guide for pharmaceutical companies on how to work successfully, collaboratively, and ethically with patients and patient groups, in line with the ABPI Code of Practice.
Vida International received an FDA warning letter after an inspection found quality control violations.
The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.
Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.
Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.
EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.
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