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Report identifies two-tier pharmaceuticals market
A report released has identified a two-tier manufacturing market and forecast increased acquisitions by Indian companies...
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U.S. Food and Drug Administration (FDA)
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FDA approves AbbVie’s Mavyret for hepatitis C
The FDA has approved Mavyret to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis...
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Biopharma stages a strong recovery
After the first half of 2017 biopharma investors are in a position to be exuberant, the threat of US price controls that have overshadowed the sector for a year have largely disappeared...
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FDA grants Breakthrough Therapy Designation status for acalabrutinib
It has been announced that the FDA has awarded AstraZeneca’s acalabrutinib product for MCL treatment Breakthrough Therapy Designation...
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Imfinzi wins breakthrough therapy designation
AstraZeneca and MedImmune, have today announced that the US Food and Drug Administration has granted breakthrough therapy designation for Imfinzi for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer...
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FDA launches Supply Chain Security Toolkit for Medical Products
The U.S Food and Drugs Administration (FDA) has led a collaboration to create a Supply Chain Security Toolkit for Medical Products to maximise the available global resources and to deliver quality training and best practices for medical products...
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Novartis combination targeted therapy receives FDA approval
The FDA has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer.
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Personalised medicine, batch size of ONE, the new challenge to fill-finish?
Wenzel Novak PhD gives some considerations on container, environment, process and automation for small batch sizes in the downstream process of fill-finish…
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FDA approves cryopreserved formulation of ReNeuron’s candidate
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
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FDA accepts application for generic version of Advair Diskus
The FDA has accepted Sandoz’s New Drug Application for fluticasone propionate / salmeterol combination product, a generic version of Advair Diskus...
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FDA approves BioMarin’s manufacturing facility in Cork, Ireland
The FDA has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Cork, Ireland for production of the formulated bulk substance.
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SpeeDx and Thermo Fisher Scientific announce strategic partnership for FDA clearance of molecular diagnostic test
ResistancePlus™ MG Test would bring disease and antibiotic resistance testing for potential “superbug”...
whitepaper
Application note: Enhanced Raman reflection spectroscopy for process analytical technology
This application note describes a proof of the concept that enhanced Raman reflection spectroscopy can generate strong Raman signal from throughout the depth of a sample....
whitepaper
Whitepaper: Possible Mechanism of Low Endotoxin Recovery
Since the risks of LER relate to the reversible biological activity change of endotoxin, it is worth reviewing previous papers on the aggregation of purified lipopolysaccharide (LPS) and its biological activity. The purpose of this article is to discuss the potency change of endotoxin in the LER by reviewing previous…
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US FDA Purchases Transmission Raman for Quantitative Analysis of Tablets and Capsules
26 October 2016 | By Cobalt Light Systems
The United States Food and Drug Administration (FDA) has purchased Cobalt’s TRS100 transmission Raman instrument for use by the Division of Pharmaceutical Analysis (DPA)...
