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10 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Mabion signed a long-term development and commercialisation agreement with Mylan Ireland a wholly owned subsidiary of Mylan N.V.
9 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Mylan and Biocon have submitted a biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA through the 351(K) pathway...
3 November 2016 | By Niamh Louise Marriott, Digital Content Producer
NICE has said eribulin, which is also called Halaven and made by Eisai, should be an option for people with locally advanced or metastatic breast cancer...
The ability to predict multiple constituents of a final dosage form in one fast, non-destructive measurement can reduce analysis time. This is especially important when quantification of multiple APIs is required for tests such as content uniformity, assay and ID...
20 October 2016 | By European Pharmaceutical Review
In this issue: Biosimilars, Informatics, Ingredients, PAT, HPLC, Microbiology, Product Showcase, Regulation, and much more...
In this Ingredients In-Depth Focus: Excipient quality and supplier interchangeability; Interpreting ICH’s evolving residual solvents guideline; Q&A with Meggle...
In the Foreword article contributed by Consultant David P. Elder in Issue 3, 2016 of European Pharmaceutical Review, entitled ‘Biosimilars: future prospects’, Dr Elder concluded that it is likely that biosimilars will become increasingly established in both Europe and the United States and that in addition to proteins and peptides,…
19 October 2016 | By Viavi Solutions Inc.
In this webinar, experts from Viavi, Pfizer & Université Laval discussed how MicroNIR is used to optimise fluid bed drying and to reduce waste at tablet compression...
27 September 2016 | By Dominic Adair and Emma Muncey, Bristows
Top litigators Dominic Adair and Emma Muncey review patent court cases to identify the legal steps you should take when marketing a biosimilar...
8 September 2016 | By Dassault Systèmes BIOVIA
This webinar shows how Lonza’s Specialty Ingredients sector successfully digitised and unified their global research operations with BIOVIA solutions...
1 September 2016 | By Niamh Louise Marriott, Digital Content Producer
Roche’s study for tecentriq (atezolizumab) met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events…
In this issue: Regulation, Environmental Monitoring, Drug Delivery; Microbiology, Track & race, Spectroscopy, HPLC, Mass Spectrometry, and much more...
Biosimilars are becoming increasingly important in the European Union’s biopharmaceutical landscape due to the increased growth of biologicals as key therapies and the financial pressure this puts on healthcare budgets.
Currently, subcutaneous delivery of therapeutic proteins is a fast-growing field, especially for such established modalities as monoclonal antibodies, which require large quantities of drug to be administrated. Different approaches, including high protein concentration, speciality formulations and drug delivery matrices, as well as devices enabling a more rapid administration of larger…
From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or…
