This week’s biotechnology news headlines include, Lilly’s biosimilar insulin approved in EU, FDA issues purple book on biosimilars, WHO urges fast work on Ebola treatments, Merck melanoma drug approved, Dengue fever vaccine shows promise, FDA drug approval recap and how caffeine evolved in plants.
Cell Culture Events
Cell Therapy Bioprocessing – September 15-16, 2014 – Sheraton Pentagon City, Arlington, VA
If you are attending Cell Therapy Bioprocesing, don’t miss:
Products for Cell Therapy and Stem Cell Workflow – High-quality, Customizable Solutions You Can Trust
Timely and accurate information enables you to make high-confidence decision faster, offering the potential to reduce cycle time and production costs. Roche Custom Biotech recognizes the complex needs and challenges associated with product research, development, manufacturing, and ultimately achieving regulatory approval. We will highlight few reagents, instruments, and services that we offer that could meet your unique requirements from discovery through commercial production.
John Ogden, Ph.D., Senior Scientific Affairs Manager, Roche Diagnostics Corporation
Ability to Detect Failure: Appropriateness and Capability of the Cedex Bio Analyzer in Media Optimization
David Scharp, MD, President and CEO, Prodo Laboratories, Inc.
And please visit our sponsor, Roche Custom Biotech at booth #12
Cell Culture World Congress USA – September 15-16, 2014 – The Westin Copley Place – Boston, MA
Stem Cells Regenerative Medicine Conference –
World Cord Blood Congress –
Bioproduction – October 8-9, 2014 – Barcelo Sants Hotel – Barcelona, Spain
BioProduction 2014 is Europe’s leading and largest event for a comprehensive update on operational strategies, technologies, regulatory challenges, manufacturing production and process development in biological manufacturing.
BioProcess International Conference & Exhibition
Conference: October 20-23, 2014, Exhibition: October 21-23, 2014
Hynes Convention Center, Boston, MA
Complete programming coverage of the full bioprocessing continuum – featuring 65 innovative case studies and 70 new data presentations intended for companies of all sizes and at every stage of development.
The world’s largest bioprocess exhibition – featuring over 150 exhibitors, lounges, and the BPI Theater with live product launches to help you plan future purchasing decisions.
Face-to-Face Networking opportunities that no other bioprocessing event can offer, plus access BPI’s event specific partnering tool to schedule meetings.
“U.S. regulators on Thursday approved the use of Merck & Co Inc’s immuno-oncology drug Keytruda, also known as pembrolizumab, as a treatment for patients with advanced melanoma who are no longer responding to other therapies.”
If you like this story, please see our blog titled “Cell Therapy for Parkinson’s Disease – Considerations for the Future“
“An experimental vaccine against dengue fever being developed by Sanofi proved about 60 percent effective in its second large clinical trial. The results could clear the way for the introduction of the world’s first inoculation against the disease, which is mosquito-borne and becoming an increasing threat.”
If you like this story, please see our blog titled “New Study Compiles Extensive Database that Supports the Importance of Vaccination”
“The World Health Organisation (WHO) called on Thursday for pharmaceutical companies and regulatory agencies to work together to accelerate development of safe and efficient drugs and vaccines against Ebola.”
If you like this story, please see our blog titled “Innovations Abound at the 2014 Annual International Society for Stem Cell Research (ISSCR) Meeting”
“Eli Lilly and Co and Boehringer Ingelheim said on Wednesday that the European Commission approved their copycat version of Sanofi SA’s blockbuster insulin, Lantus.”
If you like this story, please see our blog titled “Genome Editing and Associated Technologies”
“For those who like to track the progress at FDA, here is a significant and up-to-date metric. So far this year, the agency has approved 27 novel new medicines, a tally that includes biologics and which matches the 27 such medicines approved for all of 2013. At this rate, the FDA may come close to matching the 39 novel new medicines approved in 2012.”
If you like this story, please see our blog titled “Novel Stem Cell Technologies Presented at the 2014 Annual International Society for Stem Cell Research (ISSCR) Meeting”
“Every second, people around the world drink more than 26,000 cups of coffee. And while some of them may care only about the taste, most use it as a way to deliver caffeine into their bloodstream. Caffeine is the most widely consumed psychoactive substance in the world.”
If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”
“In Major Move on Biosimilar Interchangeability, FDA Establishes New ‘Purple Book’,” Regulatory Affairs Professional Society
“In a landmark move, the US Food and Drug Administration (FDA) has published its first-ever edition of the “Purple Book,” a new list of licensed biological products andinterchangeable biosimilars that is meant to be the biological equivalent of the pharmaceutical “Orange Book.”
If you like this story, please see our blog titled “Progress is Being Made Toward Using Cell Therapy for Type 1 Diabetes”