Researchers at the Technical University of Munich (TUM) have discovered a way of continuously and precisely dosing active agents using an oil-hydrogel mixture. / read more /
Through the agreement, Lilly will expand its immunology pipeline with lebrikizumab, Dermira’s novel, investigational mAb designed to bind interleukin-13 with high affinity. / read more /
The European Commission (EC) has approved Pfizer’s treatment for wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), Vyndaqel (tafamidis). / read more /
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma. / read more /
Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification. / read more /
The Office for Life Sciences of the government of the United Kingdom has designated six new locations in the country as ‘Life Sciences Opportunity Zones’, of which the Harwell Science and Innovation Campus is one. / read more /
Aprecia, which has an FDA-approved 3D-printed medication, will collaborate with Purdue’s College of Pharmacy to accelerate development in 3DP pharmaceuticals. / read more /
Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products. / read more /
Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase. / read more /
ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates. / read more /
Cart2CoreTM - Aseptic Cart Transferring System
VAI’s Cart2Core®, a patent pending technology, virtually eliminates the problematic issue of correct aseptic cart transference by making the cart top transferable to a new base at each new classification. / read more /
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Pharmaceutical Technology’s Regulatory Sourcebook and Reference highlights regulatory trends and enforcement actions, risk-based studies for analytical procedure validation, and generic drug applications, as well as a detailed analysis of pharmacopoeia requirements, challenges with compliance.
