News Bytes
Each month, LifeScience Alley collects interesting and timely news from the life sciences industry to include in our newsletter. Below, we have reproduced an extended version of our 'News Bytes'.
October 2008
FDA issues final rule on device-labeling revisions
The FDA has released a final rule that explains when device makers can modify the labels of their products without prior approval from the agency. The rule, which will go into effect on Sept. 22, states that label changes will be allowed only when they are based on recently acquired data, such as those from adverse-event reports, new clinical trials and analyses of previously submitted information, the FDA said. More...
Few medical students plan to go into primary care
Due to higher pay, many U.S. med students are choosing lucrative specialties over primary care, as a research letter in this week’s JAMA shows. A survey also published this week in JAMA found that only 2% of students plan to be primary care internists, while 12% planned to go into pediatrics and 5% were headed for family medicine. A comparable survey in 1990 found that 9% of students planned to go into internal medicine and practice primary care, the AP notes. While money was a factor, the new survey also found students wary of the same things that are making existing doctors flee primary care — hectic clinics, burdensome paperwork and systems that do a poor job of managing patients with chronic illness. More…
Renewable fuel plant would create jobs, coal alternative
One of Minnesota's biggest mine operators says it's building a plant on the Iron Range that will make a renewable fuel to replace coal. Cleveland Cliffs says the project, near the town of Orr, will create 25 jobs, support the area's ailing timber industry and provide a much cleaner-burning substitute for coal, which is a major source of greenhouse gases. The plant will produce a renewable bio-fuel they call Renewafuel – consisting of a small briquette that can be burned in the kinds of boilers that heat industries and schools and generate electricity. The project north of Orr is contingent on unspecified loans and grants from the Iron Range Resources Board and the Minnesota Department of Economic Development. They hope to start up in the fourth quarter of 2009. More…
Court opinion is victory for Minnesota physicians
The Minnesota Court of Appeals on September 10 released an opinion on the O’Rourke v. Buckmaster case overturning a district court ruling that would have allowed an agreement for a corrective action between a health licensing board and a licensed professional to be used as evidence of liability in a subsequent malpractice civil trial. The court’s opinion is a victory for physicians and other licensed health care professionals in the state. More…
Research finds allergy tests helpful in detecting device reactions
A U.S. study found that patch testing can help identify patients who have a metal allergy, indicating that such individuals may also be at risk for developing reactions to pacemakers and other medical devices. Researchers evaluated the results of 44 patients who underwent testing before having metallic devices implanted, and they found that in four out of five people, detection of the allergy led to a change in the product used. More...
China unveils system for postmarket medical-device monitoring
China's State Food and Drug Administration has issued a white paper detailing the government's system for tracking adverse events linked to medical devices. Under the system, 10 national centers are in charge of registration testing of imported products and domestic products with Class III classification. More...
Massachusetts unveils stem cell database
The University of Massachusetts Medical School has launched the International Stem Cell Registry, a comprehensive database of embryonic stem cell lines. The registry, which is supported by the Massachusetts Life Science Center, is the first part of a two-pronged plan. A stem cell bank will be established to house the stem cell lines, which will be globally distributed, said Brock Reeve, executive director of the Harvard Stem Cell Institute. More...
Corn lines' genetic blueprint may help improve seeds
Monsanto has developed a genetic blueprint for its female corn lines by using DNA sequencing techniques and information from the maize genome project. The breakthrough may prove useful in producing better-performing corn seeds, the company said. More...
Cell for ethanol production
Friederich Srienc's lab in the BioTechnology Institute has designed and constructed a minimal E. coli cell that converts sugars into ethanol with a high degree of efficiency. The new findings are published in the June issue of Applied and Environmental Microbiology. More…
Virtual colonoscopy as good as other colon cancer screening methods, study finds
CT colonography (CTC), known as virtual colonoscopy, is as accurate at screening for colorectal cancers and pre-cancerous polyps as conventional colonoscopy, the current screening standard, according to the National CT Colonography Trial, a nationwide multi-center study that included the San Francisco VA Medical Center. The study appears in the September 18, 2008 issue of the New England Journal of Medicine. More…
Experts offer forecast on personalized medicine
Patients in the future could go to superstores to get medical diagnoses by leaving blood or saliva specimens on a BlackBerry-like tool as well as purchase personalized drugs, industry executive G. Steven Burrill said at the AdvaMed 2008 conference. At the same gathering, an Ernst & Young official said personalized medicine will restructure business models by allowing drugmakers to market costly tailored treatments in small volumes. More...
Scientists design lens-free imaging system for counting cells
U.S. scientists are working on a lens-free imaging system that could count and identify various types of cells in blood and water samples. The device, which uses a light-sensing chip similar to those found in digital cameras, could serve as an inexpensive diagnostic tool for monitoring the health of HIV-infected patients or checking water quality, especially in underdeveloped and rural locations. More...
FDA prepares unique-identifier rule for medical devices
The FDA is preparing a proposal on unique identifiers for medical devices, an agency official said. The FDA would also have to decide which devices the regulation would apply to. "I hope it comes out this year, but given the state of things in Washington, it's hard to predict," the official said. More...
Device sector sees buyer's market for hiring
The hiring trend in the medical-device industry over the past four months has enabled companies to select from a larger group of qualified candidates who match the companies' specific area of expertise, said Nancy Simon, a Lucas Group executive. Companies no longer have to settle for less-qualified applicants and can spend less time and money for training, Simon said. More...
Bioengineered pigs could aid research on cystic fibrosis
U.S. scientists have genetically altered piglets to have the same mutation that causes cystic fibrosis. Since pigs' lungs share many qualities with human lungs, the scientists hope to gain a better understanding of how the disease develops and how it can be treated in people. More...
Drug-coated stents more beneficial after heart attack
A U.S. study of more than 7,000 patients who had a heart attack found that those who got drug-coated stents were less likely to die, suffer another attack or undergo new artery-opening operations compared with those who received bare-metal stents. The research, which involved patients in Massachusetts who were treated for heart attacks in 2003 and 2004, is significant because it is an extensive study "with long-term follow-up," the lead investigator said. More...
Eye implant stimulates nerve cells to restore vision
Researchers with the Boston Retinal Implant Project have devised an eye implant that can help restore some vision by stimulating healthy neurons connected to the retina without causing any biocompatibility issues. The researchers have successfully tested the implant in pigs and are aiming to begin human trials by 2010. More...
Scientists decode genome of penicillin-making fungus
Researchers at DSM Anti-Infectives, a Dutch biotech firm, deciphered the 13,500-gene sequence of Penicillium chrysogenum, a fungus used in commercial production of penicillin and other antibiotics. The finding could bolster efforts to create antibiotics that combat drug-resistant bacteria. More...
Biotech oilseeds must be commercialized
India's Genetic Engineering Approval Committee may allow the commercialization of biotech oilseeds, which have undergone field testing for several years, the country's agriculture secretary said at an international conference. Other government officials and industry experts at the same gathering said such crops should become available in the Indian market to boost output and lower dependence on imported supplies. More...
PGE, Columbia Energy will feed algae with CO2 to make biofuel
Portland General Electric aims to generate biofuel by using carbon dioxide emissions from one of its facilities to grow algae in a collaborative effort with Columbia Energy Partners. The companies plan to use oil extracted from mature algae to make biodiesel and livestock feed. More...
Patent disputes hinder innovation in life sciences
Researchers are calling for a better approach to protecting intellectual property in the life sciences industry after their study found that aggressive patenting was holding back innovation. The international study, led by Canadian experts, asks biotech and drug companies to look to the information technology sector for potential solutions and recommends patent pooling during late-stage research and development. More...
Biotech corn, soybeans thrive in Great Plains
Biotech varieties of corn and soybeans that can grow in drier fields have increased the yields of farmers and are competing for land traditionally used for wheat cultivation across the Great Plains, Kansas Wheat CEO Dusti Fritz said. The wheat industry is pushing for the development of biotech wheat, and it believes that such a crop will be commercialized within three to five years because of science-related advances and changes in consumer attitudes, Fritz said. More...
Guidelines for genetically engineered animals
More than two decades after the first genetically engineered animals were created, the U.S. Food and Drug Administration is proposing guidelines to regulate their commercial use. Anne Kapuschinski, a founding fellow of the Institute on the Environment, shares her expertise on the topic in a recent Science article. A conservation biologist at the University of Minnesota, Kapuscinski has written extensively about weaknesses in the science-policy link regarding possible large-scale uses of genetically engineered animals, from fish to insects. More...
Researchers develop cellulose conversion catalyst
Researchers in the United States and China have developed a new catalyst that directly converts cellulose into ethylene glycol, an intermediate product for the chemical industry. The technology uses heat, pressure, and a catalyst made of tungsten carbide and nickel on a carbon support to produce a mixture of polyalcohols from cellulosic biomass. More...