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The Dish’s Weekly News Wrap Up – October 4, 2013
This week’s headlines include, impact of the government shutdown, stem cell news, biosimilars, researchers use GE Healthcare’s sequencing services, personalized medicine, and Roche breast cancer drug gets pre-surgery approval.
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“With both the House and Senate refusing to be the first to flinch in their ongoing game of chicken Tuesday, the rest of America was getting a feel for how the first government shutdown in 17 years might affect their day-to-day businesses. For biopharma, the impact will depend on how long it takes Congress to agree on a continuing resolution to fund government agencies in lieu of a fiscal 2014 budget. The last shutdown of nonessential government programs lasted more than three weeks, from Dec. 16, 1995, to Jan. 6, 1996.”
If you like this story, please see our blog titled “Bioprocess International Conference – Thursday’s Talks”
“Nearly a year after BioTime Inc. started publicly sniffing around Geron Corp.’s stem cell assets, it landed its prize. In a complex stock-swapping and intellectual property deal, including a new subsidiary called Asterias Biotherapeutics Inc., Alameda’s BioTime (NYSE: BTX) said Tuesday that it closed a deal to buy Menlo Park-based Geron’s (NASDAQ: GRN) human embryonic stem cell assets and the rights to use certain stem cell lines. That could jumpstart groundbreaking but not yet clinically successful stem cell programs.”
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”
“Leading up to passage of the landmark 2010 legislation creating a regulatory path for the approval of biosimilars (the Biologics Price Competition and Innovation Act), both proponents of such a policy and its critics seemed to coalesce around one point in support of the law. The development of a biosimilars framework should serve as sustainable compromise between access and innovation at a time when prescription drug costs were an increasing political focus. The biosimilars policy was viewed as a preferable alternative to other legislative ideas that sought to put explicit government controls on the pricing and prescribing of higher cost drugs.”
If you like this story, please see our blog titled “Navigating the Single-use space – How to find the right cell culture bioreactor ”
“U.S. health regulators expanded the approval of Roche Holding AG’s breast cancer drug Perjeta and will now allow its use to help shrink tumors prior to surgery, the Food and Drug Administration said on Monday. The decision followed a 13-0 vote by an FDA advisory panel earlier this month in favor of the expanded approval. Perjeta was originally approved in 2012 to treat patients with advanced or late-stage HER2-positive breast cancer. It can now be used prior to surgery in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer who are at high risk of having their cancer return or spread, the agency said.”
If you like this story, please see our blog titled “Developability: Smart Ways of Avoiding the “Death of the Brave” During Biotherapeutic Development”
“Karolinska Institutet Researchers to use GE Healthcare Sequencing Services,” Genetic Engineering News
“GE Healthcare said today it will provide sequencing services to a research group at Karolinska Institutet, in the company’s first large-scale sequencing agreement in Europe. The value of the services was not disclosed. The first clinical study to use GE Healthcare sequencing technology will focus on identifying mutations and genetic variants associated with metastatic breast cancer, the company said. The large, cohort study will be conducted using tissue samples provided by Karolinska Institutet and analyzed using GE Healthcare’s next generation sequencing (NGS) capabilities.”
If you like this story, please see our blog titled “Single-Use Stirred Bioreactors – Enabling Flexible Biomanufacturing”
“Medicine’s new mantra is “the right drug for the right patient at the right time.” In other words, medical treatments are gradually shifting from a “one size fits all” approach to a more personalized one, so that patients can be matched to the best therapy based on their genetic makeup and other predictive factors. This enables doctors to avoid prescribing a medication that is unlikely to be effective or that might cause serious side effects in certain patients.”
If you like this story, please see our blog titled “Innovative Products Featured at the Bioprocess International Conference – Part I
“Where Geron Corp. failed, StemCells Inc. hopes to thrive. The Food and Drug Administration signed off on an expansion of a Phase I/II clinical trial to the United States, allowing the Newark company (NASDAQ: STEM) to enroll patients in a trial that injects its purified neural stem cells into patients with spinal cord injuries. StemCells started the trial in September 2011 in Switzerland and won approval in June to expand the study to Canada. Now that the FDA has opened the door to the United States, StemCells could accelerate enrollment in the study.”
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”