weekly biotechnology news wrap up

September 30, 2016

September 30, 2016

This week’s biotechnology news headlines include, FDA approves Amgen’s Humira biosimilar, EMA and FDA set up working group on rare diseases, Sanofi gets $43 million in US funding for Zika vaccine development, Color Genomics raises 45 million to expand genetic testing, Monsanto buys the rights to CRISPR, California passes Right to Try, and Sanaria gets Fast Track for malaria vaccine.


“FDA approves Amgen’s copy of AbbVie arthritis drug Humira,” Reuters

“The U.S. Food and Drug Administration on Friday approved Amgen Inc’s biosimilar version of AbbVie’s top-selling arthritis drug, Humira. The drug, Amjevita, known also as adalimumab-atto, was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions.”

If you like this story, please see our blog titled “The Impact of Aeration on Cell Culture Optimization

“EMA and FDA Set Up New Working Group on Rare Diseases,” Regulatory Focus

“The new collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced Monday will improve the sharing of information on various aspects of the development and scientific evaluation of medicines for rare diseases.”

If you like this story, please see our blog titled “Cool Tool – Cadence Single Pass TFF Provides in-line Concentration, Enables Continuous process

“Sanofi gets $43 mln U.S. funding to spur Zika vaccine development,” Reuters

“Sanofi SA said on Monday the U.S. Department of Health and Human Services approved $43.18 million in funding to accelerate the development of a Zika vaccine, as part of efforts to prevent the infection.”

If you like this story, please see our blog titled “Particulates in Cell Therapy Products – An important issue for commercialization

“Color Genomics Raises $45 Million to Expand Genetic Testing,” Bloomberg

“Color Genomics Inc., the three-year-old startup aiming to democratize genetic testing, sealed $45 million in funding as it seeks to make its tests for cancer more affordable and accessible, the company announced Tuesday.”

If you like this story, please see our blog titled “Predicting Differentiation and Characterizing Pluripotent Stem Cells Using Non-invasive Multi-analyte Luminex® Assays

“Monsanto Buys Rights to CRISPR,” The Scientist

“Monsanto is taking genetically engineered crops to the next level, buying a license from the Broad Institute of Harvard University and MIT to use the CRISPR/Cas9 gene-editing technology. The agreement, which is nonexclusive, is the first time the Broad has issued a license for the agricultural use of CRISPR.”

If you like this story, please see our blog titled “Reduce Cell Line Development Time by 30% and Simplify Proof of Clonality – A Case Study

“California to allow experimental drug treatments for the terminally ill,” The Hill

“Terminally ill patients in California will have access to experimental drugs that have not yet been approved by the Food and Drug Administration (FDA) under legislation signed Tuesday by Gov. Jerry Brown (D).”

If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”

“With big-name backing, Sanaria’s malaria vax gets on FDA’s ‘fast track’,” Fierce Pharma

“While GlaxoSmithKline’s first-of-a-kind malaria vaccine, Mosquirix, is tied up with pilot project obligations, a competitor may be nearing in Sanaria’s PfSPZ. The candidate won the FDA’s fast-track designation this week, giving the biotech a boost as it works toward licensure.”

If you like this story, please see our blog titled “Real Time IgG Titer Measurement Enables PAT (Process Analytical Technology) Implementation

Cell Culture Events


GE Healthcare Single-use Symposium – Boston, MA – November 1-2, 2016


Tuesday, November 1, 2016-Wednesday, November 2, 2016 at 8:00 AM – 5:00 PM EST

Marriott Long Wharf, 96 State St., Boston Massachusetts 02109

Register Here

Bioprocess Insights Webinars

The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the overall business strategy.

In this webinar series, four renowned subject matter experts will share their insights into four areas of bioprocessing: upstream, vaccines, downstream, and single-use technology. We will present tangible, recently developed data that can help you in developing modern, cost-efficient, and sustainable bioprocesses.

Don’t miss these on demand webinars – http://www.bioprocessintl.com/sponsored-content/bioprocess-insights-webinars/



  • Boston Biotech Week – Bioprocessing International Co-Located with Cell Therapy Bioprocessing – October 4-7, 2016 – Boston Convention Center and Exhibition Center – Boston, MA http://www.ibclifesciences.com/BPI/overview.xml
  • Biotech Week Boston is the destination where passionate scientists and innovators converge to partner and share ground breaking data, research and ideas.  With more than 3000+ global biotech and pharma professionals and 200+ exhibitors in attendance, BWB is your one-stop shop to gain the science, technologies and partners you need to grow your business.

Get Your $99 Biotech Week Boston Pass for Next Week!

Biotech Week Boston (Oct 4-7) is the destination where passionate scientists and innovators converge to partner and share ground breaking data, research and ideas.  Join 3000+ life science professionals working across bioprocessing, regenerative medicine, clinical trials and biorepositories.  Keynote speakers include Apple Co-founder Steve Wozniak.  Get your $99 pass today when you register with VIP code DISH99 at www.biotechweekboston.com (new registrations only)


  • 2nd Annual Cell & Gene Therapy Congress – November 3-4, 2016 – London, UK – http://www.celltherapy-congress.com/Over 250 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions.Over 20 presentations and case studies focused on the key issues in cell & gene therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing2 interactive streams:Cell & Gene Therapy: Development, Clinical Trials & CommercialisationCell Therapy Bioprocessing and ManufacturingCo-located with the established 5th Annual Cell Culture & Bioprocessing Congress and 3rd Annual Stem Cell CongressFree Pre-Congress WebinarAdvances In Gene Editing Technologies
    Presented by Richard Morgan, Vice President, Immunotherapy at Bluebird Bio. – Register for free today >>
  • 5th Annual Cell Culture & Bioprocessing Congress – November 3-4, 2016 – London, UK – http://www.cellculture-congress.com/Over 170 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions50 presentations, case studies and panel discussions focused on the key issues in cell line optimisation, process development and biological production4 interactive streams:Early Cell Line DevelopmentProcess DevelopmentLate Stage Cell Line DevelopmentBiological Production14 pre-scheduled one to one meetings, exhibition and informal networking opportunitiesCo-located with the 3rd Annual Stem Cell Congress and the 2nd Annual Cell & Gene Therapy Congress

If you are attending, don’t miss the  Reception on Thursday evening.

  • TIDES Europe – November 14-17, 2016 – Berlin, Germany – http://get.knect365.com/tides-europe/TIDES Europe is the place where oligo and peptide experts go to meet and build successful partnerships to accelerate products from early discovery through late stage development and commercialisation. In 2015 Tides Europe attracted a 40% increase in attendance across the oligo and peptide audience.
  • World Immunotherapy Congress 2016 – November 14-16, 2016 – Basel Switzerland http://bit.ly/1rbnrYy
  • World Precision Medicine – November 14-15, 2016 – Washington DC

The World Precision Medicine Congress USA is bringing together big pharma, big data, and healthcare providers to discuss the scientific, economic, and policy goals towards producing precise and genomic-based medicines. Partnered with forward-looking industry leaders such as precisionFDA and NantWorks, this event will fast-track our momentum into the future paradigm of healthcare by spurring the important discussions to get us there.

Can you afford to miss this gathering of precision medicine leaders? Pharma, big data, and healthcare providers will be there attending sessions on gene therapy, cell therapy, personalized medicine, and genomics.

Download the brochure: http://bit.ly/1N3Y0vI

Register to attend: http://bit.ly/1ObpkNV