This week’s headlines include, Appeals Court rules on embryonic Stem Cell Research, Top 25 Biotechs, innovative stem Cell Therapy developments, a new influenza vaccine study and Roche’s breast cancer drug promises longer survival.
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Cell culture has been the workhorse of biotechnology with large scale biomanufacturing of therapeutic antibodies, recombinant proteins and vaccines. Now, cells are themselves becoming medicine in the emerging field of regenerative medicine and cellular therapy. Learn how this new era of biomedicine is developing and take a guided lab tour of two companies who are at the forefront of this exciting industry. Get More InformationHeadlines:“Appeals Court Panel Says Federally Funded Embryonic Stem Cell Research Can Continue,” The Washington Post
A federal appeals court on Friday refused to order the Obama administration to stop funding embryonic Stem Cell Research, despite complaints the work relies on destroyed human embryos. The U.S. Circuit Court of Appeals for the District of Columbia upheld a lower court decision throwing out a lawsuit that challenged federal funding for the research, which is used in pursuit of cures to deadly diseases. Opponents claimed the National Institutes of Health was violating the 1996 Dickey-Wicker law that prohibits taxpayer financing for work that harms an embryo.
If you like this story, please see our blog titled “New Strategies Key to the Clinical Manufacturing of Stem Cells for Therapeutic Use”“Top 25 Biotech Companies,” Genetic Engineering News
The top 25 biotechnology companies based on market capitalization at the end of the second quarter 2012, and Q2 2011, calculated by multiplying the number of outstanding shares by the share price. U.S. companies generally report their numbers of outstanding shares in their 10-Q quarterly earnings filings with the Securities & Exchange Commission. Companies based outside the U.S. either disclose market cap directly, or their numbers of shares “in issue” or “in free issue” in half-year and full-year results disclosures.
If you like this story, please see our blog titled “Serum Free Hybridoma Culture – Key Recommendations”“No Risks Seen with Flu Shot in Early Pregnancy,” Reuters
Adding to evidence that the flu shot is safe for pregnant women, a new study finds no link between the vaccine and the risk of serious birth defects. The study, of nearly 9,000 pregnant women who got the flu shot, found that about 2 percent had a baby with a major birth defect, such as a malformation in the heart or a cleft lip. That was identical to the rate among almost 77,000 pregnant women who did not get the vaccine.
If you like this story, please see our blog titled “New Vaccines – Coming Soon to a Doctor’s Office Near You”“Roche Drug Helped Breast Cancer Patients Survive Longer,” Reuters
Swiss drugmaker Roche Holding AG said its “armed antibody” T-DM1 drug significantly extended the lives of women with an aggressive type of breast cancer compared with those receiving the standard drug cocktail. Breast cancer is the most common cancer among women worldwide, with about 1.4 million new cases diagnosed each year and more than 450,000 women dying of the disease annually, according to the World Health Organisation’s International Agency for Research on Cancer.
If you like this story, please see our blog titled “How Single Use Systems are Improving Bioprocess Development”“FDA Approves Teva Version of Amgen’s Neupogen,” Reuters
U.S. drug regulators gave the nod to a Teva Pharmaceutical Industries drug that boosts the production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy. Teva’s medicine is in many ways a copy of Amgen Inc’s biologic drug Neupogen, which faces the expiration of its U.S. patent next year. In a settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta, Amgen’s longer-lasting white blood cell booster, in the United States until November 2013.
If you like this story, please see our blog titled “FDA Issues Biosimilar Approval Guidelines”“Scientists Create Sperm from Skin Sample,” The Telegraph
Scientists have found that a man’s fertility could be restored by the growing of early stage sperm from a skin sample. Research evidence suggests that adult cells, such as those of the skin, can be induced to return to a more primitive state and then turned into different cell types.
If you like this story, please see our blog titled “Technologies for Downstream Processing in Clinical Stem Cell Manufacturing”“Genentech, U. Minnesota Scientists Discover New Colon Cancer Red Flags,” Fierce Biotech Research
After a mouse study and close scrutiny of more than 70 pairs of human tumors, Genentech geneticists and University of Minnesota Medical School scientists spotted two new genetic markers that could be crucial red flags for some types of colon cancer. The hope is that the finding could eventually lead to more personalized, gene-specific colon cancer treatments. The journal Nature published the full study online.
If you like this story, please see our blog titled “Is Personalized Medicine the Future? How Genetic Sequencing is Enabling New Treatments”“Neuralstem Completes Phase I ALS Stem Cell Trial,” Reuters
Neuralstem, Inc. (NYSE MKT: CUR) announced the completion of the Phase I trial of its NSI-566 spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), with the eighteenth patient treated. This patient, the third to return to the trial for an additional set of injections, is also the last in the Phase I portion of the trial as it is currently designed, which is scheduled to conclude six months after this final surgery.
If you like this story, please see our blog titled “Employing Innovative Platforms for Large-Scale Stem Cell Culture”