The acquisition boosts Sanofi’s pipeline of immuno- oncology product candidates with a lead candidate in development for treating solid-tumor-type cancers. / read more /
With support from academia, patient advocacy organizations, private and nonprofit companies, government organizations, and clinical trial networks funded by the NIH, a new plan was developed to focus on HBV biology, sharing tools and resources, and strategy creation. / read more /
Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting. / read more /
GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing. / read more /
Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products. / read more /
Given the complexity of different pharmacopoeias around the world, this fifth article in a series takes a closer look at ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias. / read more /
As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations. / read more /
This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed. / read more /
Your Trustworthy Partner for Global Markets Taiwan Pharmaceutical Alliance provide license in/out, CMO/CDMO, and beyond, for API & FDF. Taiwan is a PIC/S & ICH member. TPA products are launched in US, EU & Japan etc. / read more /
SMA MicroParticle ICS™ VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio. / read more /
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.
