This week’s headlines include, FDA approves gene sequencing devices, how Obamacare will impact drug spending, Roche gets EU approval, global spending on drugs, biotech meds filling pharma pipelines, Tecfideva is top potential moneymaker for 2013, and mini-kidney organs created from human stem cells.

Cell Culture Events:

Webinar: The new ReadyToProcess WAVE™ 25 bioreactor system: an expedited journey to accurate and reliable results

To learn more about GE Healthcare’s newest addition to the WAVE bioreactor line – ReadyToProcess WAVE™ 25 bioreactor system, please attend:

Date: Wednesday, 4 December 2013

Time: 09:00 CET / 14:00 CET / 17.00 CET

Speakers: Richard Ferraro, Business Leader WAVE Bioreactor system, GE Healthcare Life Sciences

Join Richard as he discusses the latest developments in the rocking bioreactor technology area. You will be shown data from investigations of how intelligent measurement and control features can easily be operated to save time and to achieve a reliable and predictable process outcome.

To register for the webinar please click – Register

Don’t Miss Vaccines: Formulation Development, Manufacturing and Novel Production Technologies December 4-5th 2013, Sheraton Brussels Hotel, Belgium

Informa’s annual Vaccines: Formulation Development, Manufacturing and Novel Production Technologies introduces an industry-led and scientific-driven agenda providing the latest in vaccine R&D innovation, optimising pre-clinical models, adjuvant and formulation development, novel production platforms, streamlining process development and manufacturing approaches. The 2013 conference provides the ideal mix of big pharma and small biotech to provide a varied and well represented networking opportunity.

Introduction to Cell Culture –December 10-13, 2013

This 4-day cell culture workshop is designed for those with no or extensive cell culture experience. Topics include an introduction to cell and tissue culture, serum containing and serum-free media, adaptation to serum-free media, cell counting and viability staining, growth curve development, growth of suspension and adherent cells, transfection technologies, cryopreservation methods, cell cloning and primary culture.

Scheduled workshops take place in Baltimore, Maryland. All of our workshops can be conducted at your location if needed. If you have questions or want more specific course content please contact our website, www.biosciconcepts.com or call us at 410-752-4224.

Headlines:

“Roche Gets EU Approval for Breast Cancer Drug,” The Wall Street Journal

“Roche Holding AG said Wednesday a breast cancer drug it has developed has been approved in Europe, cementing the company’s position in a promising new class of treatments. Basel, Switzerland-based Roche said the European Commission has approved Kadcyla, also known as trastuzumab emtansine or T-DM1, for use in patients with advanced HER2-positive breast cancer. The drug was approved by U.S. regulators in February.”Kadcyla’s EU approval is important because this type of targeted medicine has been shown in clinical studies to offer clear benefits for people with advanced HER2-positive breast cancer,” said Hal Barron, head of Roche’s global product development.”

If you like this story, please see our blog titled “Stir Up Your Culture – A Review of our Ask the Expert Session on Single-Use Bioreactors for Biopharmaceutical Manufacturing”

“FDA Approves New Gene Sequencing Devices,” The Wall Street Journal

“The Food and Drug Administration late Tuesday approved four “next-generation” gene-sequencing devices with the potential to make faster and more precise diagnoses of cystic fibrosis, the chronic disease afflicting about 30,000 patients just in the U.S. Two of the four tests have potential, too, to be used in the diagnosis and treatment of certain genetically identifiable cancers, according to the FDA. The tests are produced by Illumina Inc., of San Diego. In an article published online in the New England Journal of Medicine late Tuesday, FDA Commissioner Dr. Margaret A. Hamburg and Dr. Francis Collins, director of the National Institutes of Health, called the FDA approvals “a significant step forward in the ability to generate genomic information that will ultimately improve patient care.” They said, though, that “reimbursement issues need to be resolved to assure that patients have access to the best tests and that manufacturers have incentives to develop them.”

If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”

“First-ever “Mini-Kidney” Organs Created from Human Stem Cells,” Fierce Biotech Research

“Three-dimensional kidney structures created for the first time in a laboratory by scientists at the Salk Institute for Biological Studies could provide a way to test new drugs that treat kidney disease and restore kidney function. While other scientists have been able to create precursors of kidney cells using stem cells, the Salk team claims to be the first to coax human stem cells into forming 3-D cellular structures that imitate those found in human kidneys. The research was published Nov. 17 in Nature Cell Biology.”

If you like this story, please see our blog titled “3-D Bioprinting – When cells become ink”

“Global Spending on Drugs May Top $1 Trillion Next Year IMS Predicts,” Los Angeles Times

“Global spending on pharmaceuticals is expected to surpass $1 trillion for the first time next year, propelled in large part by the rising demand for cheap generic drugs in China and other emerging markets, according to a new forecast from the IMS Institute for Healthcare Informatics. More than two-thirds of all pharmaceutical drug spending occurs in eight countries: the U.S., Germany, France, Italy, Britain, Spain, Japan and China, the institute found.”

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

“Biotech Meds are Swelling Those Pharma Pipelines,” Forbes

“Over the past decade, the pharmaceutical industry has shifted emphasis from small molecule compounds to biotech products for a few good reasons. For one, much of the low-hanging fruit has already been picked when it comes to developing blockbuster pills for some widespread afflictions. Moreover, biotech medicines can generally command much higher price tags. The results of this shift can be seen in a new analysis. Biotech products, which accounted for 7 percent of revenue generated by the 10 top selling pharmaceutical and biotech products worldwide in 2001, accounted for 71 percent of the 10 best-selling products last year. And biotech product sales as a share of total pharmaceutical sales more than doubled to 17 percent last year from 8 percent in 2002. Overall, worldwide growth in biotech sales rose 353 percent – from $36 billion in 2001 to $163 billion in 2012.”

If you like this story, please see our blog titled “Recombinant Human Transferrin is an Attractive Alternative to Blood-Derived Transferrin in Cell Culture Applications”

“How Will Obamacare Impact Drug Spending? Tough to Say,” MedCity News

“The impact of the Affordable Care Act has been the subject of much discussion in the pharmaceutical industry. The initial enrollment period has been a bit rickety for consumers and insurers but what will be the impact on pharma one or two years from now? A new report from IMS Institute for Healthcare Informatics that it’s still unclear what the long-term impact of Obamacare on the pharma industry will be when it comes to drug spending. But some trends can already be discerned. Drug developers are facing pressure to shift away from drugs that can offer only incremental improvements in favor of drugs that can demonstrate bigger improvements in outcomes. As small molecule drugs expire, generics and biosimilars will become more competitive and account for a greater portion of the market.”

If you like this story, please see our blog titled “The Top 10 Biologic Facilities in the US”

“Biogen’s Tecfideva is Top Potential Moneymaker of 2013 Drugs – for now,” Boston Business Journal

“Stemline Therapeutics, a clinical stage biopharmaceutical company, and The Leukemia & Lymphoma Society (LLS), a voluntary health organization, have announced their collaboration to accelerate the development of SL-401 for the treatment of acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematological disorder with both leukemic and lymphomatous characteristics. LLS has committed over $3m to support this effort, as well as providing a comprehensive educational program to increase physician and patient awareness of BPDCN.”

If you like this story, please see our blog titled “Our Favorite Innovative uses of the WAVE Bioreactor Technology”