This week’s biotechnology news headlines include, Ebola news, data exclusivity for unmet need drugs, FDA approves 35 drugs in 2014, future of late stage drug development, Roche submits skin cancer drug, 3-D bioprinting, and Janssen completes deal for Halozyme platform.

Cell Culture Events

January

Introduction to Cell Culture Workshop – 4 days, January 13-16, 2015, Presented by BioSciConcepts

One of our most popular workshops, this Cell Culture Workshop covers essential fundamentals, providing a solid basis for the understanding of the growth of animal cells.  We combine lecture and laboratory exercises aimed at giving participants a deeper understanding of serum-free media applications and related topics.

Topics include: Introduction to cell and tissue culture, serum containing media and the use of serum, cell counting and viability determination, development of growth curves, growth of adherent and suspension cells, transfection technologies for recombinant protein expression in animal cells, cryopreservation and cryothawing of animal cells, cell cloning , primary cell culture and so much more.

February

Cell Line Development and Engineering – February 9-12, 2014, Dublin Ireland

http://www.informa-ls.com/event/Cellline

7^th Annual Global Biomanufacturing Summit – February 18-20, 2015, Orange County, CA

With the affordable care act and added FDA pressure on companies to cut costs to the end user it has become imperative that the biological manufacturing industry optimizes and streamlines its processes in order to maintain profit margins and stay competitive.

The 7th Annual Global Biological Manufacturing Summit 2015 has been designed to enhance collaboration, discussion and networking amongst the Biological Manufacturing community.

The 2015 will programme will feature three dedicated streams, each tackling the latest challenges for the industry: Manufacturing, Supply chain, Quality and Regulation. Each stream will feature the most esteemed companies in their fields, including UCB, GSK, MEDIMMUNE GENENTECH, M W GROUP, KINAXIS.

Visit http://www.biomansummit.com/for more information.

Book now via The Cell Culture Dish and save 15%

Cell Culture World Congress – February 23-25, 2015 –Munich Germany

http://www.terrapinn.com/conference/cell-culture/index.stm

Headlines

“NewLink Ebola Shot Test Halted in Geneva on Side Effect,” Bloomberg

“A trial of NewLink Genetics Corp.’s (NLNK) experimental Ebola vaccine in Geneva will be suspended after four cases of mild joint pain in the hands and feet of healthy volunteers.”

If you like this story, please see our blog titled “Three vaccines in development are poised to make significant impact on global public health“

“Senate Bill Offers 15 Years of Data Exclusivity for Drugs for Unmet Needs,” Wall Street Journal Pharmalot

“A bill was introduced in the U.S. Senate late last week that would provide a drug maker with an unprecedented 15 years of data exclusivity for a medicine that meets an unmet medical need. Specifically, this refers to the amount of time during which a generic drug maker would be prevented from using the data generated by a brand-name drug maker to then obtain regulatory approval and sell its own similar medicine.”

If you like this story, please see our blog titled “The Benefits of Implementing Bioprocess Monitoring and Quality by Design in Process Development”

“FDA Approves 35 New Drugs in 2014,” PharmTech.com

“Although the number of filings for new drugs dipped slightly in 2014, FDA reports that the number of new molecular entities and new therapeutic biologics approved in 2014 exceeded the number of approvals last year and the 10-year average of approvals.”

If you like this story, please see our blog titled “Genome Editing and Associated Technologies”

“Is This The Future Of Late-Stage Drug Development?” Forbes

“On Friday, Novartis announced that its anti-IL17A antibody secukinumab (Cosentyx™) demonstrated clear superiority over its rival, Stelara™ ustekinumab from Johnson & Johnson, an antibody against IL-12 and IL-23, in the treatment of psoriasis.”

If you like this story, please see our blog titled “Last Week’s BioProcess International Conference and Exhibition”

“Janssen hooks into Halozyme platform in $581m deal,” PharmaTimes

“Johnson & Johnson group Janssen Biotech has bought itself access to Halozyme Therapeutics’ drug delivery enhancing system in a deal valued at up to $581 million.”

If you like this story, please see our blog titled “Raw Material Sourcing for Cell Culture Media – Important Considerations”

“Researchers Look to Squid for Latest Eco-Friendly 3D Printing Material,” 3D Print.com

“Thermoplastics are fairly ubiquitous in the 3D printing space. As with any plastic material, though, they have always been subject to environmental concerns; how easy are they to produce, to use, to dispose of? What effects can this have on the environment? Will they maintain integrity if made with bio-based materials?”

If you like this story, please see our blog titled “3-D Bioprinting – When Cells Become Ink”

“Roche biotech unit submits skin cancer drug application to U.S. regulator,” Reuters

“Genentech, U.S. biotech unit of Swiss drugmaker Roche holding, said on Monday it had filed a marketing application to U.S. regulators for the use of its experimental drug in combination with another medicine to treat an advanced form of skin cancer.”

If you like this story, please see our blog titled “The Second Annual 24 Hours of Stem Cells Virtual Conference”

“Arca’s potential Ebola drug gets ‘orphan drug status’,” Reuters

“Arca Biopharma Inc said the U.S. Food and Drug Administration granted its experimental drug orphan drug status as a potential treatment for viral hemorrhagic fever after exposure to the Ebola virus.”

If you like this story, please see our blog titled “Cool Tool – Creating the Perfect Scientific Poster,”