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8 December 2015 | By Victoria White
Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
4 December 2015 | By Victoria White
Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
18 November 2015 | By Victoria White
The median overall survival for patients assigned personalised peptide vaccine and best-supportive care was almost twice as long as that for patients assigned best-supportive care...
Sartorius Stedim Biotech (SSB) BioOutsource today announced its expert technical staff will be speaking at and/or attending BIOLATAM, Biosimilars LATAM and Biosimilars and Biobetters conferences from November 16-19. This will provide developers of biosimilars with an excellent opportunity to discuss the optimum assay design for rapid and accurate biosimilar characterisation…
10 November 2015 | By Victoria White
CHS-0214 met its primary endpoints in a Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis...
10 November 2015 | By Victoria White
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases...
In Issue #5 2015: Counterfeit Drugs, Regulatory Insight, Raman In-Depth Focus, PAT Series, Polymorphs, RMM In-Depth Focus, Particle Sizing, Freeze Drying, and much more...
Life scientists who work with DNA, RNA and proteins can make educated decisions about sample suitability in experiments using a standalone, microvolume spectrophotometer for accurate quantitation and purity measurements to ensure downstream application success.
22 October 2015 | By Caroline Rivett and Dr Cornelius Namiluko at KPMG
Dr Cornelius Namiluko and Caroline Rivett discuss cyber security in the pharmaceutical industry and the approaches companies can take to address the risk of a cyber attack...
22 October 2015 | By Iain Moore, President, EXCiPACT asbl
There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…
22 October 2015 | By John Carpenter, University of Colorado / Amber Haynes, Fradkin KBI Biopharma / Christina Vessely, Biologics Consulting Group Inc.
Quantifying and sizing subvisible particles in biopharmaceutical products are crucial aspects of formulation development, stability studies, process development, product release and extended characterisation of the final drug product.
22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen
Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…
16 October 2015 | By CHI
Largest European Event for Biologics Returns to Lisbon from 2-6 November...
During early stage drug development, quickly obtaining relevant candidate proteins through transient transfection can accelerate drug discovery.
