PF-06410293 met primary endpoints during clinical trials and demonstrated similar efficacy to its reference product. / read more /
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PODCAST
Jennifer Zieverink, senior director of marketing and alliance management at Aprecia, and Grant Brock, vice-president of engineering at Aprecia, spoke with Pharmaceutical Technology about the company's ZipDose Technology, which is a three-dimensional printing technology used to make solid-dosage drugs.
A study of 53 cancer drugs found that new treatments extended patient life an average of 3.43 months when compared with treatments available in 2003. / read more /
The number of novel drugs approved in 2016 by FDA's CDER department was half the number approved the previous year; many of the complete response letters issued in 2016 were a result of preapproval inspection. / read more /
Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency. / read more /
PARTICIPATE! Need your input for BioPlan's 14th Annual Global Biopharmaceutical Manufacturing Study - BioPlan will donate $10 (up to $2,000) on your behalf to global health charities - Be the first to receive a FREE Aggregated Summary of this year's results AND receive our UPDATED 15 Top Trends in Biopharmaceutical Manufacturing White Paper. Learn more
Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability. / read more /
Synpromics will help GE Healthcare improve its manufacturing platforms and overall yield by providing synthetic promoters to the company for an upfront access fee. / read more /
Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design. / read more /
The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article. / read more /
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products. / Click here /
Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.
