This week\u2019s headlines include, Gene Therapy approved in Europe, new breast cancer drug gets priority review, top ten women in biotech, new HIV vaccine shows promise, and Sandy delays some drug decisions at FDA.\n\nHeadlines:\n\n\u201cFDA Gives Priority Review to ImmunoGen Roche Breast Cancer Drug,\u201d Fox Business\n\nThe U.S. Food and Drug Administration has granted priority review to an investigational breast cancer treatment that is being developed by Genentech and ImmunoGen Inc. (IMGN), the companies said. The drug, trastuzumab emtansine, is in global development by Roche Holding AG (RHHBY, RO.EB, ROG.VX) under an agreement between Roche unit Genentech and ImmunoGen. Trastuzumab emtansine's proposed use is to treat people with an aggressive form of breast cancer, categorized as HER2-positive, that has metastasized or can't be removed with surgery. ImmunoGen's technology uses monoclonal antibodies to deliver cancer-killing agents specifically to tumor cells.\n\nIf you like this story, please see our blog titled \u201cTumor Cell Panels Help Researchers Develop New Cancer Treatments\u201d\n\n\u00a0\n\n\u201cEurope Approves High-Price Gene Therapy,\u201d Reuters\n\nEuropean officials have approved the Western world's first Gene Therapy drug from a small Dutch biotech company, in a milestone for the novel medical technology that fixes faulty genes. The formal clearance from the European Commission paves the way for a launch next summer of the treatment for an ultra rare genetic disease that will cost around 1.2 million euros ($1.6 million) per patient, a new record for pricey modern medicines. After more than 20 years of experiments and a series of disappointments, the EU approval of Glybera, which treats the genetic disorder lipoprotein lipase deficiency (LPLD), is a significant boost for the Gene Therapy field.\n\nIf you like this story, please see our blog titled \u201cLean Development Approaches in the Era of Quality by Design \u2013 Mission Impossible?"\n\n \n\n\u201cTen Top Women in Biotech 2012,\u201d Fierce Biotech\n\nFierceBiotech's "10 Top Women in Biotech" honorees are highlighted in this report.\u00a0 They include top innovators in life sciences.\n\nIf you like this story, please see our blog titled \u201cHow Stem Cells Can Play a Major Role in Developing New Therapeutics\u201d\n\n \n\n\u201cCanadian Developed HIV Vaccine Shows Promising Results, No Adverse Effects, Say Developers,\u201d Toronto Star\n\nA Canadian-made HIV vaccine has cleared a major hurdle. Scientists announced on Tuesday that initial results from human clinical trials show no adverse effects and significantly boosted immunity. Developed by researchers at Western University in London, Ont., it\u2019s the first and only preventative HIV vaccine based on a genetically modified killed whole-virus. It has shown promising results after Phase 1 trials.\n\nIf you like this story, please see our blog titled \u201cNew Vaccines Coming Soon to a Doctor\u2019s Office Near You\u201d\n\n \n\n\u201cFDA Says Sandy Delays Decisions on Some Drugs,\u201d Reuters\n\nHealth regulators will delay decisions on some drugs for up to two days because of the massive storm Sandy, which closed the federal government. The Food and Drug Administration said on Friday that the delay in meeting regulatory timelines for prescription drugs, medical devices and biosimilar drugs would apply to those with target dates around October 29 and 30, when offices were closed. For those drugs with target dates on October 31 or later, the agency will consider whether a delay is warranted, but it will not exceed two days.\n\nIf you like this story, please see our blog titled \u201cFDA Strives to Provide Faster Approval Time for Drugs by Employing \u201cSpecial Medical Use\u201d Category\u201d\n\n \n\n\u201cWhen Genetic Engineering Came of Age,\u201d Forbes\n\nToday marks the 30th anniversary of an event that kicked off an important new era in drug therapies \u2013 the approval by the FDA of human insulin synthesized in genetically engineered bacteria.\u00a0 The saga is remarkable in several ways, not least of which is that although both the drugmakers and regulators were exploring unknown territory, the development of the drug and its regulatory review progressed smoothly and rapidly. Insulin in crude form was first produced in 1922 by Canadian researchers Frederick Banting and Charles Best, lifting the death sentence that had previously been imposed on diabetics.\u00a0 By the end of that year drug company Eli Lilly and Company had devised a method for much higher purification.\u00a0 Over the next half century or so, the purified insulins obtained from pig or cow pancreases were constantly improved in purity and formulated in ways that refined their performance.\n\nIf you like this story, please see our blog titled \u201cIn Celebration of Chinese Hamster Ovary (CHO) Cells \u2013 a Biopharmaceutical Manufacturing Powerhouse\u201d\n\n \n\n\nCreate your free online surveys with SurveyMonkey, the world's leading questionnaire tool.