FDA finalizes guidance on clinical researchers' financial disclosures

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March 14, 2013 More than 2,700 companies nationwide are saving on lab supplies, shipping, news distribution, office products and more through the BIO Business Solutions cost-savings program. Find out how. The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.   Today's Top Story  FDA finalizes guidance on clinical researchers' financial disclosures The FDA has issued final guidance governing financial disclosures by clinical researchers. The agency said it plans to publish researchers' personal financial data after approval of new devices, drugs and biologics. The agency clarified that it won't release investigator names, but it will likely release data such as the number of researchers with disclosable financial ties. Clinica (subscription required) (3/11)        Health Care & Policy  FDA proposes easier path to Alzheimer's drug approval The FDA proposed approving Alzheimer's disease drugs that subtly improve memory or reasoning in clinical trial participants with mild or no symptoms. Researchers praised the proposal. The proposal was published online in the New England Journal of Medicine and is open for comments. The New York Times (tiered subscription model) (3/13)      FDA gives Quidel nod on molecular respiratory viral test The FDA has given Quidel 510(k) clearance to sell its Molecular RSV + hMPV test, which is used to identify the presence of human metapneumovirus and respiratory syncytial virus as well as differentiate them from each other. The assay already is available for sale in Europe. GenomeWeb Daily News (free registration) (3/12)      Chimerix secures fast-track status for antiviral drug The FDA granted a fast-track status to Chimerix's CMX001 for prevention of cytomegalovirus infection. The drug previously received a fast-track designation for smallpox and adenoviral disease in post hematopoietic stem cell transplant patients. CMX001 prevents double-stranded DNA viruses from replicating. Pharmaceutical Business Review Online (3/13)        Company & Financial News  Nabsys pulls in $20M for sequencing platform A Series D funding round led by Bay City Capital has brought in $20 million for Nabsys. The Providence, R.I.-based company plans to use the proceeds to support the commercialization of its semiconductor-based positional single-molecule sequencing platform. GenomeWeb Daily News (free registration) (3/13)        Industry Deals  Presidio, Boehringer team up on trial of hep C drug combo Presidio Pharmaceuticals and Boehringer Ingelheim agreed to collaborate in a midstage clinical study of an interferon-free, combination therapy for hepatitis C. The trial, which will start next quarter, will evaluate Presidio's PPI-668, in combination with Boehringer's protease inhibitors BI201335 and BI207127. American City Business Journals/San Francisco/BiotechSF blog (3/13)      Firms team up to develop companion Dx for solid tumor drugs Leica Biosystems and Synthon Biopharmaceuticals will collaborate in the development of companion diagnostics for the latter's antibody-drug conjugates for solid tumors. The assays will be based on Leica's automated advanced staining systems. GenomeWeb Daily News (free registration) (3/12)      Evogen gives OK for PCR probe technology use by Focus Diagnostics Focus Diagnostics secured the right to use Evogen's HyBeacons PCR probe technology in its molecular diagnostic products and services. Evogen's PCR probe platform generates "clear quantitative data" during amplification and has "proven capabilities with DNA and RNA targets," the firms said. GenomeWeb Daily News (free registration) (3/13)        Food & Agriculture  Study: Lysozyme-rich milk from biotech goats can treat diarrhea Milk rich in lysozyme, an antimicrobial protein found in human milk, from biotech goats successfully treated young pigs with diarrhea caused by bacterial infections in the gut, according to a study published in the journal PLOS One. Researchers hope the milk can also benefit children with bacterial diarrhea. "These results provide just one example that, through genetic engineering, we can provide agriculturally relevant animals with novel traits targeted at solving some of the health-related problems facing these developing communities," said James Murray, the study's lead researcher. MedicalDaily.com (3/14)        Industrial & Environmental  Zeachem's Ore. biorefinery makes successful first run Zeachem's demonstration-scale biorefinery in Boardman, Ore., has yielded its first batch of ethanol and renewable chemicals from poplar chips. The facility's equipment performed without a hitch and the successful initial run is a "great validation of the technology," said Jim Imbler, the company's president. The Seattle Times (3/12)      The Buzz(CORPORATE ANNOUNCEMENTS) CD Diagnostics is Proud to Announce that it will be Featured in an Upcoming Episode of Health Heroes Sucampo Pharmaceuticals, Inc. 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