Court dismisses AstraZeneca's FDA lawsuit A US court has denied AstraZeneca's request for a preliminary injunction against the FDA. AstraZeneca filed a lawsuit against the US agency at the beginning of March with regards to the antipsychotic medicines Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate). More...
Europe adopts transparency guideline The European Medicines Agency has outlined a European-wide approach for dealing with transparency and access to information in marketing authorisation applications. More...
Stem cell therapy sparks FDA warning letter The FDA has sent a Warning Letter to IntelliCell Biosciences, which had been promoting a tissue-derived stem-cell product for the treatment of wrinkles and osteoarthritis, as well as for breast augmentation. More...
GSK investment causes UK celebration GlaxoSmithKline has given the UK government and several trade organisations reason to celebrate after announcing that it will build a new manufacturing facility in the country — the first in almost forty years. More...
Join our community on LinkedIn Want to discuss any of this week's news stories or any other hot topics in the industry? Then why not join our group on LinkedIn? More...
Hospira One 2 One® contract development and fill-finish manufacturing of injectable products packaged in vials, PFS, cartridges, ampoules.
Broad range of capabilities: Biologics; Potent drugs; Vaccines; Cytotoxics; Beta-lactams; Lyophilization. Read more
New Mill
2-Day Webcast Auction Sale of Contract Pharmaceuticals Limited Niagara - April 18 & 19, Buffalo, NY, 500,000 Sq. Ft. Contract Processing & Packaging Facility. Read more
Tosoh Bioscience
TSKgel Protein C4-300 – Speed and resolution for protein analysis
Tosoh Bioscience is introducing a new reversed phase HPLC column for the separation of intact protein. Read more
Event Profile
Biological Production Forum
24th-26th September 2012
Düsseldorf
Germany
The Biological Production Forum attracts senior level biopharmaceutical industry professionals working within manufacturing, process development and product operations. The global biological production industry is under pressure amidst challenging price restrictions, US health care reforms and reduced revenues. Read more
Pharma Outsourcing & Procurement Summit 2012
The Pharma Outsourcing and Procurement Summit 2012 addresses the urgent need for pharma to identify and locate the best outsourcing partnerships and solutions to stay competitive in an uncertain climate whilst addressing heightened regulatory pressures and need to maintain high quality standards.
Read more
What has been the most significant development in biologic-based drug manufacturing over the past 10 years?
Improvement in upstream yields
21%
Advancement of single-use technologies or disposables
28%
Application of quality-by-design principles
30%
Improvements in downstream bioprocessing/purification
21%
This week we would like to know...
What is your opinion of FDA's new guidance on TV DTC advertising?
