This week’s headlines include, investments looking up for biotech, new bird flu vaccine on horizon, Geron close to spinning out stem cell business, NIH develops one-stop shop for disease genes, clinical trial database gaining steam and benefits of optimizing cell lines for production.
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This year has seen 12 biotech IPOs, and others are in the pipeline. So far, this has pumped some $800 million into the sector, according to Renaissance Capital, an IPO-research company based in Greenwich, Connecticut. And biotech stocks are doing well — the NASDAQ Biotech Index has outperformed the NASDAQ Composite Index for the past 20 months.
If you like this story, please see our blog titled “Best Selling Biologics for 2011- CHO Still the Top Manufacturing Choice”
An advisory panel to the U.S. Food and Drug Administration on Wednesday voted unanimously that a GlaxoSmithKline Plc prototype vaccine against bird flu appears to be safe and produces the desired immune-system response against the highly fatal virus. The London-based drugmaker said the advisory panel of outside medical experts voted 14 to 0 to support its vaccine against the H5N1 bird flu virus. The virus is spread among birds but sometimes infects people, with highly fatal consequences.
If you like this story, please see our blog titled “Manufacturing Strategies for Improving Viral Yield and Lowering Production Cost in Vaccine Manufacturing”
Geron has taken a step toward striking a deal that could revive development of its stem cell therapies. The Menlo Park, CA-based biotech and BioTime inked a letter of intent, a non-binding agreement, which outlines some of the terms for a BioTime subsidiary to take over Geron’s embryonic stem cell programs that were shelved last year as Geron narrowed its focus to cancer drug development.
BioTime’s interest in scooping up the stem cell programs from Geron has been public knowledge since at last month, with news that ex-Geron CEO Thomas Okarma was angling for the assets to beef up the pipeline of the new BioTime subsidiary under his leadership. Geron and BioTime haven’t hammered out all the details of a deal, but the letter of intent seems to increase the likelihood that Okarma is close to regaining control of the stem cell therapies.
If you like this story, please see our blog titled “Part II Ten Companies with Innovative Stem Cell Therapies in Clinical Trials”
Developed by the US National Institutes of Health (NIH) National Center for Biotechnology Information (NCBI) in Bethesda, Maryland, ClinVar integrates dozens of existing databases. It also provides, for the first time, a central place in which clinical testing laboratories can deposit their data, because most currently keep their data within the laboratory. By aggregating such information, ClinVar’s creators hope to accelerate clinicians’ understanding of the effects of variants as well as reveal whether different laboratories are interpreting the same variant in different ways. “There is a growing recognition that a clinical lab may see a mutation once or never, so it’s better if all those data could be pooled,” explains James Ostell, chief of the information engineering branch at the NCBI and a member of the ClinVar team. Such information could not only help laboratories to improve quality, it could also prompt research on new variants.
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”
Johnson & Johnson, Merck & Co Inc and Eli Lilly & Co, plan to launch a one-stop database of global clinical trial sites aimed at streamlining paperwork and speeding the process for testing new drugs. The partners have begun securing approval from as many as 100,000 clinical investigators to enter their details into the database, Andreas Koester, head of clinical trial innovation/external alliances at J&J’s Janssen unit, said in a telephone interview.
If you like this story, please see our blog titled “Cultureware – A New Generation of Products Step Up to the Plate”
Of all the activities that constitute a bioprocessing operation, a good argument could be made that the most critical step involves optimizing cell-line development. That was one of the main messages delivered at CHI’s “Bioprocessing Summit”, in the late summer. Jesús Zurdo, Ph.D., head of innovation for biopharma development at Lonza Biologics, discussed the challenges and advantages of various strategies for minimizing high attrition rates related to “dwindling R&D productivity and spiraling development costs,” and the resulting cost pressures on process development for microbial fermentation and mammalian cell culture. According to Dr. Zurdo’s model, risk may enter the picture anywhere during development, including preclinical studies, human testing, or manufacturing.
If you like this story, please see our blog titled “How Stem Cells Can Play a Major Role in Developing New Therapeutics”