The Dish’s Weekly News Wrap Up – September 20, 2013

This week’s headlines include, possible government shut down over health care, patient groups investing in research, FDA lifts hold on Pluristem study, Neostem licesnes UCSF patent, FDA panel backs Roche drug for early breast cancer, stem Cell Therapy protects vision in retinal disease and CDC states that not vaccinating kids is driving up U.S. measles rate .

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“Government Shutdown Moves Closer to Reality,” The Washington Post

“The threat of a government shutdown intensified Tuesday as House Republican leaders moved toward stripping funding from President Obama’s landmark health-care initiative and setting up a stalemate with the Democratic Senate. House Speaker John A. Boehner (R-Ohio) had hoped to keep the government open past Sept. 30 with relatively little fuss. But roughly 40 conservatives revolted. After a strategy session Tuesday, Boehner and his leadership team were being pushed into a more confrontational strategy that would fund the government into the new fiscal year only if Democrats agreed to undermine Obama’s signature legislative achievement.”

If you like this story, please see our blog titled “Bioprocess International Conference – Tuesday’s Talks

“Patients Share DNA for Cures,” The Wall Street Journal

“Patients with rare and deadly diseases are getting a powerful new boost. Cancer foundations and other nonprofit patient groups are investing tens of millions of dollars to build genetic databases in an effort to speed drug development and jumpstart clinical trials. The databases are designed to collect DNA and other information from patients with hard-to-treat diseases. The material can be analyzed for certain genetic mutations and made available to scholars and pharmaceutical companies.”

If you like this story, please see our blog titled “Developability: Smart Ways of Avoiding the “Death of the Brave” During Biotherapeutic Development

“FDA Panel Backs Approval of Roche Drug in Early Breast Cancer,” Reuters

Roche Holding AG’s drug Perjeta, currently approved to treat metastatic breast cancer, should also be approved to help shrink tumors prior to surgery, an advisory panel of the U.S. Food and Drug Administration said on Thursday. The panel voted 13 to 0, with one abstention, that the drug’s benefits outweighed its risk, even though the trial to determine its safety and efficacy was small, with 107 patients taking Perjeta in combination with Roche’s drug Herceptin and chemotherapy and 107 taking Herceptin plus chemotherapy alone.”

If you like this story, please see our blog titled Navigating the Single-use space – How to find the right cell culture bioreactor

“Stem Cell Therapy Protects Vison in Preclinical Retinal Disease Study,” Fierce Biotech Research

“A cellular therapy developed by Newark, NJ-based StemCells ($STEM) preserved sight in a rat model of retinal disease, pointing to a promising new option to treat vision loss. Researchers observed that, when treated with the company’s proprietary purified human neural stem cells (HuCNS-SC), animals with retinal degeneration maintained the number of light-detecting cells called photoreceptors that would otherwise be lost to the disease. Furthermore, the surviving photoreceptors appeared to be healthy and normal, and maintained their synaptic connection to other important cells necessary for visual function, according to a study published in the journal Investigative Ophthalmology and Visual Science.”

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

“FDA Lifts Hold on Pluristem Therapeutics Study,” Bloomberg Businessweek

“The Food and Drug Administration has lifted a clinical hold it had placed in June on the study of a Pluristem Therapeutics Inc. stem Cell Therapy. Pluristem said Monday it can proceed with its study after the FDA said it had addressed all the issues that led to the clinical hold. A brief statement from the Israeli company did not elaborate. Pluristem said in June that the hold on the mid-stage study was caused by a patient who suffered a severe allergic reaction to treatment and was hospitalized. The company said a total of 74 patients have been treated in its studies and this was the first serious allergic reaction.”

If you like this story, please see our blog titled “Single-Use Stirred Bioreactors – Enabling Flexible Biomanufacturing

“CDC: Vaccine “Philosophical Differences” Driving Up U.S. Measles Rate,” CBS News

“Measles was declared eliminated from the United States in 2000, but anti-vaccination beliefs may be playing a role in bringing the disease back, a new government report suggests. The Centers for Disease Control and Prevention investigated more than a decade’s worth of data on measles cases (including 2013 cases through the end of August) and found that most patients had not been vaccinated.”

If you like this story, please see our blog titled “Bioprocess International Conference – Wednesday’s Talks

“Neostem Licenses UCSF Patents Covering Methods for Tregs,” Genetic Engineering News

“Neostem said today it licensed three families of patents from the University of California, San Francisco (UCSF), collectively covering methods to isolate, expand, and use the company’s human regulatory T cell (“Treg”) platform with therapeutic potential for autoimmune disorders. The value of the license agreement was not disclosed. Patents covered by the license include U.S. Patent 7,722,862, which claims a cellular immunotherapy for the treatment of type 1 diabetes. As a result of the license, NeoStem’s patent estate for its Treg program now includes exclusive rights to 22 issued patents in United States and major international commercial geographies. Those rights cover isolation, activation, expansion, and methods of treating or preventing certain conditions and/or diseases using Tregs, NeoStem said.”

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


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