This week’s 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.
The 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.
If you like this story, please see our blog titled “Tumor Cell Panels Help Researchers Develop New Cancer Treatments”
European 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.
If you like this story, please see our blog titled “Lean Development Approaches in the Era of Quality by Design – Mission Impossible?”
FierceBiotech‘s “10 Top Women in Biotech” honorees are highlighted in this report. They include top innovators in life sciences.
If you like this story, please see our blog titled “How Stem Cells Can Play a Major Role in Developing New Therapeutics”
A 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’s the first and only preventative HIV vaccine based on a genetically modified killed whole-virus. It has shown promising results after Phase 1 trials.
If you like this story, please see our blog titled “New Vaccines Coming Soon to a Doctor’s Office Near You”
Health 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.
If you like this story, please see our blog titled “FDA Strives to Provide Faster Approval Time for Drugs by Employing “Special Medical Use” Category”
Today marks the 30th anniversary of an event that kicked off an important new era in drug therapies – the approval by the FDA of human insulin synthesized in genetically engineered bacteria. 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. By the end of that year drug company Eli Lilly and Company had devised a method for much higher purification. 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.
If you like this story, please see our blog titled “In Celebration of Chinese Hamster Ovary (CHO) Cells – a Biopharmaceutical Manufacturing Powerhouse”
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