The Dish’s Weekly News Wrap Up – August 22, 2014

This week’s biotechnology news headlines include, new US aid workers go home after having Ebola, FDA discussing stem cell therapies, Roche looking at Chugai, meningitis B vaccine update, Fabry disease treatment on the horizon, Gallus to manufacture Progenics’ monoclonal antibody, and tentative ok for Basaglar to treat diabetes.

Cell Culture Events


Cell Line Development & Engineering – September 8-10, 2014 – Doubletree by Hilton Berkeley Marina Berkeley, CA

Cell Therapy Bioprocessing – September 15-16, 2014 – Sheraton Pentagon City, Arlington, VA

If you are attending Cell Therapy Bioprocesing, don’t miss:

Products for Cell Therapy and Stem Cell Workflow – High-quality, Customizable Solutions You Can Trust
Timely and accurate information enables you to make high-confidence decision faster, offering the potential to reduce cycle time and production costs. Roche Custom Biotech recognizes the complex needs and challenges associated with product research, development, manufacturing, and ultimately achieving regulatory approval. We will highlight few reagents, instruments, and services that we offer that could meet your unique requirements from discovery through commercial production.
John Ogden, Ph.D., Senior Scientific Affairs Manager, Roche Diagnostics Corporation

Ability to Detect Failure: Appropriateness and Capability of the Cedex Bio Analyzer in Media Optimization
David Scharp, MD, President and CEO, Prodo Laboratories, Inc.

And please visit our sponsor, Roche Custom Biotech at booth #12

Cell Culture World Congress USA – September 15-16, 2014 – The Westin Copley Place – Boston, MA

Stem Cells Regenerative Medicine Conference

World Cord Blood Congress


Bioproduction – October 8-9, 2014 – Barcelo Sants Hotel – Barcelona, Spain

BioProduction 2014 is Europe’s leading and largest event for a comprehensive update on operational strategies, technologies, regulatory challenges, manufacturing production and process development in biological manufacturing.

Bioprocessing International – October 20-23, 2014 Hynes Convention Center Boston, MA


“U.S. Aid Workers Who Survived Ebola Leave Atlanta Hospital,” Reuters

“Appearing thin but smiling, a Texas doctor who weeks ago entered an Atlanta hospital in a full-body biohazard suit to be treated for Ebola said on Thursday he was “thrilled to be alive” as doctors declared him virus-free and safe for release.”

If you like this story, please see our blog titled Novel Stem Cell Technologies Presented at the 2014 Annual International Society for Stem Cell Research (ISSCR) Meeting

“Stem Cell Therapy: FDA Regulatory Science Aims to Facilitate Development of Safe and Effective Regenerative Medicine Products,” FDA Voice

“One of FDA’s primary missions is to make sure that the products we approve are safe and effective. There is tremendous interest in the development of regenerative medicine, including numerous proposed products that rely on stem cells. Stem cells have the ability to generate more stem cells or to turn into more mature cell types such as nerve- or bone-producing cells. These properties make stem cells potentially well suited for use in regenerative medicine. They might be used in repairing heart, nerve, and brain damage or in treating diabetes and other diseases by repairing or replacing cells and tissues.”

If you like this story, please see our blog titled Release Your Cells – A Simple New Tool that Eliminates the Need for Manual Selection and Scraping in hPSC Passaging

“Roche in Talks to Buy Chugai in $10 Billion Deal,” Bloomberg

“Roche Holding AG is in talks to buy the almost 40 percent of Chugai Pharmaceutical Co. that it doesn’t already own to gain full control of its Japanese partner for oncology and arthritis drugs, according to people familiar with the matter.”

If you like this story, please see our blog titled Innovations Abound at the 2014 Annual International Society for Stem Cell Research (ISSCR) Meeting

“FDA Sets Decision Date for Pfizer’s MenB Candidate,” Fierce Vaccines

“Pfizer ($PFE) and Novartis ($NVS) are in a dead heat to become the first vaccinemaker to roll out a meningitis B vaccine for the U.S. market. But the New York pharma giant just became the first of the two to snag a decision date from the FDA, which says it will have an answer on Pfizer’s candidate within the next 6 months.”

If you like this story, please see our blog titled “New Study Compiles Extensive Database that Supports the Importance of Vaccination

“Amicus Lead Drug Nears Approval as Late-stage Trial Succeeds,” Reuters

“Amicus Therapeutics Inc is a step closer to bringing its first drug to the market after trial data paved the way for its lead drug to become the first oral treatment for patients with a disorder that causes an abnormal build-up of fat.”

If you like this story, please see our blog titled “Single-use Perfusion Culture Enables Continuous Bioproduction.”

“Gallus Enters Agreement With Progenics Pharmaceuticals, Inc. For Manufacture of Anti-PSMA Monoclonal Antibody,” Pharmaceutical Online

“Gallus BioPharmaceuticals, LLC, a premier, full service biopharmaceutical contract development and manufacturing organization (CMO) announced today that it has been selected by Progenics Pharmaceuticals, Inc., an oncology company focused on the development of innovative approaches to targeting and treating cancer, to manufacture the anti-prostate specific membrane antigen (PSMA) monoclonal antibody used in Progenics’ PSMA ADC product candidate. Under the agreement the antibody will be produced in Gallus’ commercial manufacturing facility in St. Louis, Missouri.”

If you like this story, please see our blog titled Flexible Facilities for Biopharmaceutical Manufacturing”

“Tentative US OK for Lilly/BI’s Basaglar,” PharmaTimes Online

“The US Food and Drug Administration has granted tentative approval for the use of Eli Lilly/Boehringer Ingelheim’s basal insulin Basaglar, for long-lasting control of blood sugar levels in patients with diabetes in between meals and during the night.”

If you like this story, please see our blog titled Progress is Being Made Toward Using Cell Therapy for Type 1 Diabetes

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