This week’s headlines include, stem cell news, FDA plan for innovative drugs trials, biotech hubs are shifting in ranking, biotech business news, and FDA pathway for Alzheimer drugs.

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Headlines:

“FDA Approves UCLA IND Application to Commence Embryonic Stem Cell Based Trial,” Pharmaceutical Business Review

“The USFDA has approved the investigator investigational new drug (IND) application of University of California, Los Angeles (UCLA), the clinical partner of Advanced Cell Technology (ACT), to commence a clinical trial using the human embryonic stem cells (hESCs)-derived cells to treat severe myopia. Embryonic stem cell-based trial was designed to assess the hESC-derived ACT’s retinal pigment epithelial (RPE) cells in patients with severe myopia (nearsightedness).”

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

“Innovative Drugs May Win U.S. Approval After Early Trials,” Bloomberg Businessweek

“Drugmakers may win approval from U.S. regulators for “breakthrough” therapies after a single round of studies, rather than three, in an effort to speed them to patients, a Food and Drug Administration official said. The agency assigned three experimental medicines the new status to try to reduce the time needed to get them to market against deadly diseases, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said yesterday in an interview before a Bloomberg health conference in New York. Vertex Pharmaceuticals Inc. (VRTX) said last month that two of its drugs for cystic fibrosis had won the designation.”

If you like this story, please see our blog titled “How Stem Cells Can Play a Major Role in Developing New Therapeutics”

“Sanofi Boosting Stake in U.S. Biotech Regeneron,” Reuters

“French drugmaker Sanofi SA (SASY.PA) is buying more shares in U.S. biotech company Regeneron Pharmaceuticals Inc (REGN.O), its partner in the development of potential blockbuster treatments for cholesterol and rheumatoid arthritis. Sanofi’s plans, disclosed by the companies in separate statements on Monday, boosted both companies’ shares. Sanofi controls 16.7 percent of Regeneron, or 15.82 million shares, according to Reuters data. Sanofi said in an email that it has the right to raise the stake to as much as 30 percent under its decade-long partnership with Regeneron.”

If you like this story, please see our blog titled “In Celebration of Chinese Hamster Ovary CHO Cells – a Biopharmaceutical Manufacturing Powerhouse”

“As NJ Sheds Pharma Jobs, Other Major Metro Areas Emerge as New Hubs for Life Sciences,” NJ Spotlight

“The steady departure of pharmaceutical industry jobs in recent years has helped other states, but hurt the standing of the nation’s medicine chest. As more companies take root in far-flung locations, the New Jersey and New York City region has dropped significantly in the national ranking of life sciences markets, according to a recent report on commercial real estate. Last year, the region slipped to seventh place among metropolitan life sciences clusters from second place in 2011, according to the latest annual report from Jones Lang LaSalle, the commercial real estate firm. The reasons cited for the slide: ongoing consolidation following big mergers and the simultaneous efforts among such cities as San Diego to offer competitive environments.”

If you like this story, please see our blog titled “Innovative Products Featured at the ASCB Conference Part I”

“Amgen Biosimilar Push Takes Aim at Blockbusters,” Reuters

“Amgen Inc said it expects generic versions of biotech drugs, known as biosimilars, to be a multibillion-dollar opportunity for the company and has targeted some of the industry’s biggest sellers, including the main rivals for its own blockbuster rheumatoid arthritis drug Enbrel. The company on Thursday also said that between this year and 2016 it will have key late-stage data from eight experimental medicines. Amgen Chief Executive Robert Bradway, at a meeting in New York to update analysts and investors on business strategy, said the company plans to launch six biosimilars beginning in 2017 – four cancer drugs and the two Enbrel rivals – Abbvie’s Humira and Remicade, which is sold by Johnson & Johnson and Merck & Co Inc.”

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

“3D Printed Human Embryonic Stem Cells Created for First Time,” Live Science

“Imagine if you could take living cells, load them into a printer, and squirt out a 3D tissue that could develop into a kidney or a heart. Scientists are one step closer to that reality, now that they have developed the first printer for embryonic human stem cells. In a new study, researchers from the University of Edinburgh have created a cell printer that spits out living embryonic stem cells. The printer was capable of printing uniform-size droplets of cells gently enough to keep the cells alive and maintain their ability to develop into different cell types. The new printing method could be used to make 3D human tissues for testing new drugs, grow organs, or ultimately print cells directly inside the body.”

If you like this story, please see our blog titled “The Value of Cord Blood Stem Cells in Healthcare and Research”

“FDA Outlines Path to Test Alzheimer’s Drugs Earlier,” Reuters

“Proposed U.S. guidelines may make it easier for drug companies to test Alzheimer’s treatments in people at an earlier stage, when scientists think they may have the best shot at working. The draft guidance document, issued on Thursday by the U.S. Food and Drug Administration, reflects changes in scientists’ understanding of Alzheimer’s. They now believe the disease begins at least a decade before symptoms appear.”

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

“StemCells Soars After Spinal Trial Gains Persist in 2 Patients,” Fierce Biotech

“Shares of StemCells ($STEM) soared 23% this morning after the biotech announced some positive preliminary results from a tiny trial for chronic spinal cord injury. The company said that “considerable gains in sensory function observed in two of the three patients at the six-month assessment have persisted” through the 12-month mark. “In addition, between the six- and 12-month evaluations, one patient converted from a complete to an incomplete injury,” said Armin Curt, the principal investigator of the clinical trial.”

If you like this story, please see our blog titled “Part II Innovative Products Featured at the ASCB Conference”