news
Complete response letter handed to Sarepta Therapeutics
The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.
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QA/QC
news
MHRA consultation on application of AQbD principles enters last month
An MHRA consultation is due to end on 31 August, with public comments on AQbD principles closing soon.
article
Cannabinoids in pharma series: cannabinoids on the market today
This series investigates the growing interest from the pharmaceutical industry in cannabinoids. In this first piece, we hear from industry experts about the current situation of the ingredient on the pharmaceutical market.
news
Letter highlights issues with US drug returns verification requirements
An open letter has underscored the challenges of return failure in the US drug supply chain, especially after the introduction of the Drug Supply Chain Security Act in November.
whitepaper
Application note: Cell-Based Therapies – Be on the Safe Side
Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment.
whitepaper
Whitepaper: USP <797> Revisions and Impact
The United States Pharmacopeia (USP) is a scientific non-profit organization that sets standards used worldwide for the identity, quality, purity and strength of medicines, food ingredients and dietary supplements.
webinar
Accelerate food, pharmaceutical and particle analysis with Raman imaging
7 August 2019 | By WITec GmbH
This webinar describes how Raman microscopy can help solve some of the most vital and challenging questions that researchers face in 3D imaging and microparticle analyses of food, pharmaceuticals and microplastics, along with providing measurement examples from each field.
whitepaper
Whitepaper: Recent advances in pharmaceutical regulations for viable environmental monitoring
Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly.
article
Climate change: how pharma will profit from a warming planet
Rising temperatures will likely accelerate the spread of vector-borne diseases, resulting in an increased demand for vaccines. European Pharmaceutical Review investigates a Morgan Stanley report on the pharmaceutical beneficiaries of climate change.
news
Tecan Synergence™ offers comprehensive approach to OEM system development
Tecan Partnering has consolidated its extensive OEM system development services for life sciences and IVD instruments to create Tecan Synergence™.
article
Surge in negative verifications of saleable returns could cost pharma industry billions
The pharmaceutical industry is set to face some major changes in the near future, to improve the quality of returned drugs and medications.
news
PharmaLab 2019 – In times of changes
For the 7th time, PharmaLab, picks up the latest developments in regulations, quality control and assurance and in laboratory methods and systems.
news
Roche confirms cyber-attack from Winnti malware
The pharmaceutical company Roche has affirmed that it was hit by a Winnti cyber-attack, thought to be supported by the Chinese government.
news
Two lots of Kogenate® recalled due to mislabelling
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
news
FDA approves nine generics for Lyrica drug
The FDA has announced that it has granted approval to the first nine generic drug applications for Pfizer’s Lyrica treatment.
