Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar. / read more /
The company entered two separate collaborations with Advaxis and Array Biopharma involving its PD-1 immune checkpoint inhibitor Opdivo. / read more /
advertisement
Podcast
Finn Bauer talks about Parteck SRP 80, an excipient for direct compression of matrix-based, sustained-release tablets. Parteck SRP 80 won the Excellence in Excipients Award at the 2016 CPhI Pharma Awards.
The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland. / read more /
Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter's primary role will be in the fill and finish aspect. / read more /
BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017. / read more /
AGILENT 280-DS MQS CAPABILITIES EXTENDED
The Agilent 280-DS Mechanical Qualification System (MQS) simplifies dissolution qualification. The system that has taken the dissolution industry by storm now has even more capabilities. / Read more/
Spray Dry Technology for Pharmaceutical Development
With the acquisition of Pharmatek Laboratories, Catalent now offers spray drying as part of its bioavailability toolkit, complementing its comprehensive suite of development and formulation solutions. / Read more/
GMP Laboratory Testing Services
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies. / Read more/
A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. / Click here /
Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.
