The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions. / read more /
The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan. / read more /
Check out the PharmTech Europe Supplement on APIs,
Excipients, and Manufacturing,
includes the
CPhI Worldwide
Planning Guide.
FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products. / read more /
The National Institute for Health and Care Excellence recently rejected National Health Service’s funding of Kymriah for diffuse large B-cell lymphoma (DLBCL) despite recognizing that the drug has significant clinical benefits. / read more /
The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors. / read more /
The company's biosimiliar to Amgen's Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). / read more /
GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy. / read more /
This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance. / read more /
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars. / read more /
LCMS-9030 Q-TOF: Effortless performance
Celebrating this year the 50th anniversary of its presence in Europe, Shimadzu emphasizes its Excellence in Science approach through the release of the new LCMS-9030 quadrupole time-of-flight liquid chromatograph mass spectrometer. / Read more/
This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
