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Quality by Design (QbD) precepts provide opportunities for enhancing efficiencies and reducing costs, especially for generic products. Over 80% of prescriptions dispensed in the United States in 2012 utilised generic dosage forms and it is unlikely that this proportion will increase to any extent because fewer innovative drugs are set…
Spray drying is a proven, flexible and scalable process used within the pharmaceutical industry to address a wide range of formulation and drug delivery challenges. Its versatility has been proven through applications to both small chemical and biopharmaceutical drugs for product delivery via multiple routes of administration.
Linkam Scientific Instruments, announce the launch of the FDVS platform, a lyophilisation system to replicate large scale freeze drying processes...
15 November 2016 | By Niamh Louise Marriott, Digital Content Producer
B is for Biosimilar - the next instalment of our daily pharmaceutical alphabet bringing you up to date with all the latest news and research on the subject of biosimilars.
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…
