The Dish’s Weekly News Wrap Up – March 01, 2013

This week’s headlines include, challenges for biosimilars, Genentech hiring, single-use systems bioreactors on the rise, flu vaccine news, stem cell company funding and AAP guidelines for genetic testing in children.

Cell Culture Events:

Webinar on Gene Synthesis

In a previous blog titled “Utilizing Gene Synthesis to Improve Antibody Production in CHO Cells,” we discussed the use of gene synthesis technology to improve antibody production in CHO cells. Life Technologies, one of the companies mentioned in our blog, hosted a webinar on using gene synthesis as a fast, simple alternative to traditional cloning. The webinar is now available to view through archive. Please click “Building your next breakthrough using next-generation cloning; Gene Synthesis” for more information.

 

Headlines:

“Biotech Drugs Still Won’t Copy,” The Wall Street Journal

“Much anticipated knockoff versions of costly biotech medicines are facing delays and obstacles that could cost patients and health systems billions in missed savings. Several high-profile projects to create so-called biosimilar drugs have faltered in recent months. Merck MRK -0.56% & Co. dissolved a dedicated biosimilar unit last year and in December retreated from a plan to copy arthritis treatment Enbrel after maker Amgen Inc. AMGN +0.57% gained a new patent. Last fall, Samsung Electronics Co.’s 005930.SE +1.11% biosimilar unit suspended trials for a version of the cancer drug Rituxan, and generic-drug maker Teva Pharmaceutical Industries Ltd. TEVA -0.16% halted its own Rituxan push.”

If you like this story, please see our blog titled Comments on Biosimilar Guidance Indicate Discontent on Both Sides of the Issues”

 

“Genentech Expected to Hire 600 Employees,” CBS News SF Bay Area

“Genentech expects to fill nearly 600 new positions this year, many at their South San Francisco headquarters. The Bay Area biotech giant consistently lands on Fortune Magazine’s list of top companies to work for. Positions vary from the expected M.D.’s and Ph.D.’s to IT classifications and salespeople. The company reported that it has a staggering “785,000 square feet devoted to research, more than 10,000 patents received and 35 medicines on the market.”

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

 

“ATMI: Single Use Bioreactors on the Up, but US Tails Europe,” in-Pharma Technologist.com

“New innovations in single-use bioprocessing systems are being picked up quicker in Europe than in the US, according to ATMI.”

If you like this story, please see our blog titled Identifying Options for Stem Cell Based Therapy Scale Up”

 

“FDA Panel Expands Flu Vaccine,” The Wall Street Journal

“A federal advisory panel on Wednesday signed off on adding an additional strain of influenza protection to some of next year’s vaccines. The change, which has been in the works for years, could better prepare the health system after this year’s nasty flu season. For decades, influenza vaccines have been comprised of three different strains to protect people against the flu. Those vaccines won’t immediately go away, but over time will be replaced by new four-strain, or quadrivalent, vaccines.”

If you like this story, please see our blog titled “Severe Flu Season Puts Spotlight on New Vaccine Technologies and Existing Challenges”

 

“Texas Biotech Rounds up $2 Million for Platform to Grow Stem Cells Faster,” MedCity News

“A University of Texas spinoff company has pulled in $2 million to test a new technique for culturing non-embryonic stem cells. According to a regulatory filing, StemBioSys raised at least $2 million of a $3.5 million equity offering. A company representative was not available to elaborate, but CEO Dr. Steven Davis told the San Antonio Business Journal last year when the company began raising the round that it would fund research projects to validate the quality of the stem cells generated by the company’s technology. StemBioSys is developing XC-marrow ECM, a propriety three-dimensional culture for growing mesenchymal stem cells from bone marrow, adipose tissue and umbilical cord blood. These immature cells have multiple potential uses in research and therapeutics because they can self-renew and mature into a variety of cell types.”

If you like this story, please see our blog titled Best Practices in Cell Therapy Manufacturing”

 

“AAP Issues Guidelines for Genetic Testing for Children,” Health Day News

“Use of genetic testing and screening for children should be guided by their best interests and offered in the context of genetic counseling, according to an American Academy of Pediatrics (AAP) policy statement published online Feb. 21 in Pediatrics. Lainie F. Ross, M.D., Ph.D., from the AAP Committee of Bioethics, and colleagues provide recommendations for use of genetic testing and screening of minors in various scenarios.”

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

 

“Blood Drug Woes Could Weigh on FDA and its Approval of New, Copycat Biologic Medicines,” Forbes

The announcement last night that Affymax (NASDAQ: AFFY) is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward. Omontys was recalled following some fatal, severe allergic (anaphylactic) reactions that occurred within 30 minutes of receiving the first dose. Unless the problem can be traced to an obvious additive in the product or some characteristic in affected patients that made them susceptible to the reactions (enabling doctors to avoid dosing high risk patients) then quick re-introduction of the drug could be challenging.”

If you like this story, please see our blog titled The Number of FDA Drug Approvals for the 2012 Fiscal Year Remains High

 

 

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