This week’s biotechnology news headlines include, FDA special approval pathways, drugmakers talking to insurers early, Bayer purchases rights to Isis’ drug, cancer drug market hits 100 billion, Novo Nordisk creates new manufacturing facility, compassionate use issues, and Alexion agrees to purchase Synageva.

Cell Culture Events

Conferences:

May

• PEGS Boston – May 4-8, 2014 – Seaport World Trade Center – Boston, MA http://www.pegsummit.com/
• Cell Line Development & Engineering – May 18-20, 2015 – Parc 55 Wyndham San Francisco, CA http://www.ibclifesciences.com/CellLine/overview.xml Co-located with Bioconjugates: From Targets to Therapeutics – http://www.ibclifesciences.com/Bioconjugates/overview.xml and Next Generation Protein Therapeutics Summit – http://www.ibclifesciences.com/ProteinSummit/overview.xml
• 10^th Annual World Stem Cells and Regenerative Medicine Conference 2015 – May 20-22, 2015 – Business Design Centre, London, UK Scaling up, commercialization and collaboration for market access.
• Cord Blood World Europe Congress 2015 – May 20-21, 2015 – Business Design Centre, London, UK Build deposits, reduce costs, retain quality, decrease volume and increase utilization.
• ISCT – May 27-30, 2015 – Caesars Palace Hotel, Las Vegas, NV http://www.isct2014.com/
• Cell Culture World Congress USA – http://www.terrapinn.com/conference/cell-culture-world-congress-usa/index.stm Americas Antibody Congress http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52321.stm World Biosimilar Congress http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52322.stm Downstream Processing World http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52323.stm May 27-28, 2014 – Marriott San Diego Mission Valley – San Diego, CA

June

• Empowered Antibodies Congress 2015 – June 17 – 18 2015, Barcelona, Spain http://www.informa-ls.com/event/empoweredantibodies15
• Annual Meeting of the International Society for Stem Cell Research – June 24-27, 2015, -Stockholm, Sweden http://www.isscr.org/home/annual-meeting/isscr2015
• BIO International Convention – June 15-18, 2014 – Philadelphia, PA http://convention.bio.org/
• Viral Safety and Raw Materials Congress – June 24-25, 2015 – Austria Trend Hotel Savoyen – Vienna, Austria http://www.informa-ls.com/CQ3546VSRMCONGRESScellcultureJoin us at this year’s Viral Safety and Raw Materials Congress taking place in Vienna on the 24^th-25^th June to network and exchange with leading industry representatives, regulatory bodies and top level technology providers from across the globe to discuss and debate the latest trends in this changing sector.

  Packed with case studies, interactive tutorials, discussion panels and workshops, the conference agenda will provide you with key take home messages to benchmark your businesses’ strategies with regards to safeguarding against viral contamination enhancing the quality of your products.

  Covering all the key topics within the field of viral safety for biologics and raw materials, hear the latest on next generation detection technologies, supplier auditing, risk assessment techniques and raw material analytics from leading players including Roche, Genzyme, Sanofi Pasteur, Crucell and Abbott.

  For more information, please visit the event website: www.vsrm-congress.com (please hyperlink to: http://www.informa-ls.com/CQ3546VSRMCONGRESScellculture)

August

• The Bioprocessing Summit – August 3-7, 2015 – Westin Copley Place – Boston, MA http://www.bioprocessingsummit.com/

 Headlines

“Speedy Drug Approvals Have Become the Rule, Not the Exception,” The New York Times

“Congress has over the past few decades passed a series of special approval pathways for important drugs that treat life-threatening or rare diseases. This week, a new bill introduced in the House could add two more.”

If you like this story, please see our blog titled “The Evolution of Vaccine Manufacturing – Past, Current, and Future Trends”

“Gilead’s Gaffe Leads Drugmakers to Pledge More Openness on Price,” Bloomberg Business

“Drugmakers worried about a backlash over soaring drug prices are increasingly talking with insurers ahead of time about paying for new therapies that could cost six figures a year.”

If you like this story, please see our blog titled “Cool Tool – Minimize the Impact of Stress on Pluripotent Stem Cell Health in a Range of Workflows”

“Bayer buys rights to Isis Pharma’s anti-clotting drug,” Reuters

“German drugmaker Bayer secured the rights to an experimental anti-blood-clotting drug in a deal with California-based Isis Pharmaceuticals to bolster its cardiovascular business led by blockbuster pill Xarelto.”

If you like this story, please see our blog titled “A New Model for Continuous Processing in Downstream Purification”

“The Cancer Drug Market Just Hit $100 Billion And Could Jump 50% In Four Years,” Forbes

“The global market for cancer drugs has hit $100 billion in annual sales, and could reach $147 billion by 2018, according to a new report by the IMS Institute for Healthcare Informatics, a unit of drug data provider IMS Health.”

If you like this story, please see our blog titled “Materials and Assay Systems Used for 3D Cell Culture”

“Novo Nordisk A/S (NVO)’s $225 Million Hemophilia Facility Will Create 100 New Jobs,” BioSpace

“Danish pharmaceutical giant Novo Nordisk (NVO), the world’s largest insulin maker is investing $225 million into a new hemophilia treatment manufacturing site in Kalundborg, Denmark, Reuters reported this morning.”

If you like this story, please see our blog titled “2014 FDA New Drug Approvals – 11 Biologics Receive Approval”

“J&J Changes ‘Compassionate’ Care,” The Wall Street Journal

“Under increasing pressure to expand access to experimental medicines, Johnson & Johnson has arranged for an independent panel to review requests from seriously ill patients who want to try an unapproved drug even if they aren’t participating in the drug’s testing.”

If you like this story, please see our blog titled “Closed Systems in Biomanufacturing Offer A Variety of Benefits”

“Alexion Bets $8.4 Billion on Synageva in Rare-Disease Push,” Bloomberg Business

“Alexion Pharmaceuticals Inc. agreed to buy Synageva BioPharma Corp. for $8.4 billion in cash and stock, expanding its collection of treatments for rare diseases to reduce its dependence on a single drug.”

If you like this story, please see our blog titled “Continuous Downstream Processing – A Tool to Address Key Manufacturing Challenges”