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November 20, 2018
During CPhI Worldwide in Madrid, Lynne Byers, executive director of NSF International detailed the facts about how Brexit can impact the pharmaceutical industry.
November 16, 2018
Pharma industry welcomes announcement of a draft withdrawal agreement, stating it is an important step towards securing a Brexit deal.
Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.
November 14, 2018
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.
November 12, 2018
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
November 09, 2018
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.
November 08, 2018
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.
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
November 06, 2018
An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.