This week’s headlines include, 217 vaccines in development, Roche enters into immunotherapy deal with Inovio, European Commision approves first biosimilar, Biogen and Isis pair up on neurological drugs, Novartis and Regenerex enter stem cell deal, FDA speeds approvals, and America Stem Cell gets FDA approval for nationwide trials.
Next Week Blogging From the BioProcess International Conference and Exhibition
Cell Culture Events:
Now celebrating its 10th Anniversary, BPI attracts experts from all bioprocessing and biomanufacturing disciplines and all levels, from research scientist to group leader to senior level executive who share and discuss their challenges in an interactive, learning environment.
Don’t miss the talk “Controlling Process Variability Due to Raw Material Variability,” By Dave Kolwyck, MS, MBS, Principal Scientist, Amgen
Please Check out our Sponsor’s Activities at Bioprocess International by Visiting our BPI Sponsor Page
Visit with The Cell Culture Dish
Editor and Chief Brandy Sargent will be attending BPI this year and will be available to meet with interested parties. Are you are interested in specific blog topics, new blog features, or advertising and sponsorship opportunities? If so, please use BPI Connect to schedule a meeting with Brandy.
Three Great Conferences – All in Cambridge, September 30 – October 1
Cell Culture World Congress USA is North America’s premier cell culture optimization and development conference, with a focus on upstream processes. This is where biopharma and biotech biomanufacturing and process experts come to debate advances in cell culture optimization and development. Save 15% with promo code ECYB! For more information please go to www.terrapinn.com/CC13CCDish
“A vaccine to slow the progression of HIV and a monoclonal antibody that protects against influenza are among the nearly 300 vaccines under development by drug makers in the United States, according to a new report by a drug industry trade group.”
If you like this story, please see our blog titled “Vaccines – An Interesting Discussion on Past, Present, and Future”
“The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. FDASIA section 902 provided for a new designation, the breakthrough therapy designation, for new drugs. Since last July, the agency has received a total of 82 applications for the designation, and has published a draft guidance titled “Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics” on June 25, 2013.”
If you like this story, please see our blog titled “Developability: Smart Ways of Avoiding the “Death of the Brave” During Biotherapeutic Development”
“Swiss drugmaker Roche has struck an exclusive global licensing deal with Inovio Pharmaceuticals to develop vaccines to fight cancer and hepatitis B. Under Tuesday’s deal, Roche will pay $10 million up front, with development and commercial milestones of up to $412.5 million for exclusive access to Inovio’s DNA-based vaccines INO-5150 for prostate cancer and INO-1800 for hepatitis B.”
If you like this story, please see our blog titled “Navigating the Single-use space – How to find the right cell culture bioreactor ”
“The FDA has cleared America Stem Cell Inc. to proceed with its planned Phase I/IIa nationwide multi-center dual umbilical cord transplantation study to examine whether stem cells can effectively treat patients. The company will evaluate ASC-101 in patients with hematologic malignancies and myelodysplastic syndrome.”
If you like this story, please see our blog titled “Moving Your Cell Therapy from Concept to Product – A discussion about navigating funding and grant writing, partnering with organizations and the regulatory process”
“The European Commission green-lighted a lower-priced “biosimilar” version of Johnson & Johnson and Merck & Co.’s Remicade treatment for rheumatoid arthritis, in the first of what will likely be a string of approvals creating competition for a class of expensive therapies. The Remicade rival, named Inflectra and from Hospira Inc. and Celltrion Inc., is the first low-priced version of an agent known as a monoclonal antibody to receive EC approval, according to Hospira, which announced the approval Tuesday.”
If you like this story, please see our blog titled “Single-Use Stirred Bioreactors – Enabling Flexible Biomanufacturing”
“Biogen Idec has agreed to pay another $100 million upfront to Isis Pharmaceuticals Inc as part of a broad collaboration to develop new medicines for neurological disorders, the companies said on Monday. The news sent Isis’s shares up 9 percent in premarket trade. The deal is the fourth between the companies in the last two years, and aims to use the “antisense” technology invented by Isis to accelerate discovery of drug targets for neurodegenerative diseases.”
If you like this story, please see our blog titled “Perfusion Bioreactors – With so much to offer they deserve a closer look”
“Novartis AG entered a collaboration with Regenerex LLC, gaining access to stem cell technology that may help kidney transplant patients avoid taking anti-rejection medicine for life. Regenerex, a startup biology company based in Louisville, Kentucky, and Novartis have entered an exclusive global licensing deal and will work together on research, the Basel, Switzerland-based company said in an e-mailed statement today.”
If you like this story, please see our blog titled “Advances in Adherent Cell Culture Approaches Abound – Promoting Progress in Production Performance for Attachment Dependant Processes”