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August 16, 2017
Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine.
August 11, 2017
The Thermo Scientific Pharma mini implant line is built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.
August 02, 2017
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
August 01, 2017
Successful development requires coordinating and aligning drug and device design, focusing on a complete drug delivery system that meets patients’ needs.
July 21, 2017
The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
July 05, 2017
SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.
ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.
June 29, 2017
The agency announced a plan to eliminate its existing orphan designation request backlog.
June 13, 2017
Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York.
At an industry seminar hosted by Leistritz Extrusion, experts explained the use of extrusion equipment to mix polymeric excipients with APIs for solubility enhancement and for multifunctional and specialty dosage forms, including implants.