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14 July 2016 | By Victoria White, Digital Content Producer
The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product...
7 July 2016 | By Victoria White, Digital Content Producer
The EGALITY study involved 531 patients and compared the efficacy and safety of biosimilar etanercept with the originator product, Enbrel...
5 July 2016 | By Victoria White, Digital Content Producer
Celltrion is to develop laboratory tests that will enable physicians to identify when patients on an anti-TNF drug require a change of dose...
Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself...
In this issue: Biosimilars, Regulation, Packaging, Microfluidics, Microbiology, PAT, Antibiotic Resistance, and much more...
30 June 2016 | By Victoria White, Digital Content Producer
ImmBio has reported positive results from the First-in-Human study of its novel vaccine, PnuBioVax, against the bacterial pathogen Streptococcus pneumoniae...
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable...
Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion globally. However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small molecule…
30 June 2016 | By Adrian Funke - Bayer Pharma AG / Reinhard Gross, Stephan Tosch and Albert Tulke - Bayer Technology GmbH
Process analytical technology (PAT), namely near-infrared (NIR) and Raman spectroscopy, has already been shown to be a useful tool for monitoring, analysing and optimising the complex process of lyophilisation. The latter process is especially challenging in the case of biopharmaceutical formulations due to the instability of active ingredients, leading to…
With the rise in drug-resistant bacterial infections heralding a new, dark era of medicine, antibiotics alternatives could one day become the first-line defence against infectious diseases. With the urgent need to find new approaches clear, Caroline Richards, Editor of European Pharmaceutical Review, interviewed Dr. Bjorn Herpers, Chief Medical Advisor of…
28 June 2016 | By Victoria White, Digital Content Producer
Pfizer is to invest $350 million in the development of a state-of-the-art Global Biotechnology Centre in the Hangzhou Economic Development Area...
28 June 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation for Zavicefta for the treatment of patients with serious Gram-negative bacterial infections...
21 June 2016 | By Victoria White, Digital Content Producer
The addition of relebactam is designed to restore activity of imipenem against certain imipenem-resistant strains of Gram-negative bacteria...
20 June 2016 | By Victoria White, Digital Content Producer
Santos will be responsible for Amgen's Operations organisation, including manufacturing, process development, quality, engineering and global supply chain...
17 June 2016 | By Victoria White, Digital Content Producer
Pfizer will invest more than $200 million in the development of the state-of-the-art facility that will enable the production of high-quality, complex biologics...
