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April 02, 2014
Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses eClinical supply-chain management.
Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.
Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.
Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.
April 01, 2014
Advanced drug delivery technologies can increase efficacy and safety, extend patent lives, and provide competitive differentiation for biopharmaceuticals.
March 26, 2014
Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.
March 20, 2014
Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. Results showed that BioChaperone Combo provided both short- and long-term control of blood glucose in type I diabetic patients, with a faster onset and a longer duration of action.
Novartis has launched the prefilled syringe formulation of Lucentis (ranibizumab) in Germany, with other markets to follow throughout 2014. The prefilled syringe formulation has been specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.
The Pediatric Praziquantel Consortium has been awarded a research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. The grant will be used to fund the Consortium's clinical development program of a newly developed praziquantel pediatric formulation targeted for use in very young children, including infants and toddlers, infected with schistosomiasis.
March 12, 2014
To gain insights into the current trends of the biotechnology sector in the United Kingdom, Pharmaceutical Technology Europe spoke with Steve Bates, chief executive officer of the BioIndustry Association (BIA), the trade association for biotech companies in the UK.
