The Dish’s Weekly Biotechnology News Wrap Up – November 20, 2015
This week’s biotechnology news headlines include, Europe could soon approve second arthritis biosimilar drug, Merck completes acquisition of Sigma-Aldrich, CMS rule on biosimilar payment, AstraZeneca’s new lung cancer pill receives early U.S. approval, whooping cough in infants tied to epilepsy, FDA approves Gilead’s Hepatitis C drug for expanded use, and FDA to examine maternal vaccines to protect infants.
Cell Culture Events
Webinar:
Thursday, December 3, 2015 11:00 AM EST or 8:00 AM PST
Overview:
Join Dr. Tommy de Windt, Resident Orthopaedic Surgeon and Investigator, and Roche Custom Biotech in this FREE webinar to gain expert insights and innovative solutions regarding how to maximize viable, functional cells and meet regulatory requirements. Using a unique combination of mammalian tissue-free, GMP and Sterile A-grade products, Thomas will discuss the development of a Cell Therapy application.
Session Highlights
- Discover how to produce viable, functional cells with maximum yield from donor organs with high reproducibility
- Explore Class-A sterile products to fulfill regulatory requirements and ensure contamination free products
- Realize the importance of Mammalian Tissue Free (MTF) products in order to avoid risk of transmission of mammalian diseases.
Conferences:
December
- Cell Therapy Manufacturing & Gene Therapy Congress – December 1-4, 2015 – Sheraton Brussels Airport Hotel Discover the latest technical, manufacturing and commercial strategies driving the cell and gene revolution. ISCT together with Informa’s has developed the Cell Therapy Manufacturing and Gene Therapy Congress agenda bringing together key players from the industry to discuss the critical issues facing the development, scale-up and manufacture of cell-based and gene therapies, all in line with international regulations, from scale-up to scale-out, characterisation to process release, freeze/ thaw to needle-to-needle logistics. http://www.informa-ls.com/event/celltherapy15
- Antibody Engineering and Therapeutics – December 7-10, 2015 –San Diego Convention Center – IBC’s Antibody Engineering & Therapeutics is the largest and most trusted antibody engineering and therapeutics event in the industry! Join us in San Diego to hear and learn from an impressive collection of world-renowned and highly-published academic and industry scientists, as they share the latest science, strategies and preclinical/clinical development efforts. http://www.ibclifesciences.com/AntibodyEng/overview.xml
- Vaccine Development and Production Summit – December 8-9, 2015 – Hilton Boston Back Bay, Boston, MA IBC’s Vaccine Development & Production Summit continues to bring you new data on ways to achieve your development and production goals. This year, hear the challenges and triumphs of product developers who continue to advance their innovations to combat emerging and infectious diseases. – http://www.ibclifesciences.com/Vaccines/overview.xml
- World Stem Cell Summit & RegMed Capital Conference– December 10-12, 2015 – Hyatt Regency, Atlanta, Georgia-The World Stem Cell Summit, produced by the Genetics Policy Institute (GPI), is the largest interdisciplinary, networking meeting of stem cell science and regenerative medicine stakeholders, uniting the diverse community. With the overarching purpose of fostering biomedical research, funding and investments targeting cures, the Summit is the single conference charting the future of this burgeoning field. – http://worldstemcellsummit.com/about-summit/
- ASCB – December 12-16, 2015 – San Diego Convention Center, CA – The 2015 ASCB meeting overarching theme is about making connections at different scales, from the intracellular level to the tissue level, to the organism level all the way up to the macrocosmic level, all in the light of big data and information integration. This integration will help us ask the right questions and find answers to the challenging problems in medicine, living systems, and ecosystems.- http://www.ascb.org/2015meeting/
Visit Essential Pharmaceuticals Booth #748 at ASCB
Attend the Tech Talk:
“Variables in FBS Impact Cell Performance, Reproducibility and Relevant Experimental Results”
Tuesday Dec. 15, 2015 2:00 – 2:45 PM
Exhibit Hall, Theatre #2
Headlines
“Europe could recommend second biosimilar arthritis drug this week,” Reuters
“Europe could soon gain a second biosimilar antibody drug for rheumatoid arthritis and other autoimmune diseases, with regulators due to decide by Friday whether to recommend South Korean company Samsung Bioepis’s copy of Enbrel.”
If you like this story, please see our blog titled “Cool Tool – Allegro™ Microcarrier Delivery System: Streamline Processes, Increase Productivity”
“Merck KGaA, Darmstadt, Germany, Completes Sigma-Aldrich Acquisition,” Fierce Pharma
“Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced the completion of its $ 17 billion acquisition of Sigma-Aldrich, creating one of the leaders in the $ 130 billion global industry to help solve the toughest problems in life science.”
If you like this story, please see our blog titled “Culturing Hematopoietic and Progenitor Stem Cells – Key Tips and Tools”
“CMS Rule On Biosimilar Payment Could Have Serious Side Effects,” Forbes
“The Obama administration and leading members of Congress are clashing over a new Medicare payment rule that could compromise patient care, impede development of a fledgling part of the biologics industry, and make it more difficult to track patient safety issues.”
If you like this story, please see our blog titled “BioProcess International Conference (BPI) 2015 – An Overview For Anyone Who Missed It!”
“AstraZeneca’s potential $3 billion cancer pill wins early approval,” Reuters
“A new lung cancer pill from AstraZeneca (AZN.L), designed for patients whose disease has worsened after treatment with other therapies, won early U.S. approval on Friday, in a boost for the British drugmaker.”
If you like this story, please see our blog titled “Cool Tool- Hybridoma cell growth and performance in reduced serum + Zap-SR”
“Whooping Cough in Infants Tied to Epilepsy Risk,” The New York Times
“Whooping cough in infancy is associated with an increased risk for epilepsy, a new study has found. The findings underscore the importance of vaccination for whooping cough, also known as pertussis, in childhood.”
If you like this story, please see our blog titled “Exosomes: A Major Phenomenon Flying Under the Radar”
“U.S. FDA approves Gilead’s hepatitis C drug for expanded use,” Reuters
“Drugmaker Gilead Sciences Inc said on Thursday the U.S. Food and Drug Administration had approved the expanded use of its blockbuster hepatitis C drug, Harvoni.”
If you like this story, please see our blog titled “Hollow Fiber Provides a Sweet Spot for Several Biomanufacturing Applications”
“FDA panel to examine ‘maternal vaccines’ to protect infants,” Fierce Vaccines
“Several manufacturers are already developing vaccines to protect infants via maternal immunization, but the potential of such vaccines has “yet to be fully realized.” This Friday, an FDA advisory panel will examine the development and licensing of these “maternal vaccines,” MedPage Today reported.”
If you like this story, please see our blog titled “You can teach an old dog new tricks: Vero cells for virus-based cancer vaccine therapies”