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EU Food Facility Grant To Increase Farmers' Productivity
Small-scale farmers in Africa, Asia and Latin America are
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AAMC Commends Final National Institutes of Health's Stem Cell Guidelines
AAMC (Association of American Medical Colleges) President and CEO Darrell G. Kirch, M.D., issued the following statement on the final National Institutes of Health"s (NIH) Guidelines on Human Stem Research, published today:
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Senate HELP Panel Begins Mark Up Of Bill Placing Tobacco Under FDA Oversight
The Senate Health, Education, Labor and Pensions Committee on Tuesday began marking up a bill (S 982) that would allow FDA to regulate tobacco products, CongressDaily reports. The bill would allow FDA to place larger, color warning labels about the health risks of smoking on cigarette packs, as well as to regulate the marketing of tobacco products and advertising to children. The agency could not ban tobacco products or eliminate nicotine from cigarettes, but it could regulate their production and ban flavored cigarettes other than menthol. Sen. Chris Dodd (D-Conn.) said, "Over the years, this bill has been reviewed; it has been vetted; it has been debated, over and over and over again. The time has come to act." The House in April passed its version of the bill, 298-112 (Hunt, CongressDaily, 5/20). The committee by voice vote approved an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would give FDA priority to review products that contain nicotine, such as candies. Committee ranking member Mike Enzi (R-Wyo.) proposed two amendments, one that would have given regulatory authority over tobacco to CDC and another that would have ordered FDA to study which flavors to ban, instead of a current provision that bans specific flavors. Both amendments were defeated. Enzi said, "I think the FDA is the wrong regulator. It approves cures, not poisons." The only Democrat who opposed the bill was Sen. Kay Hagan (N.C.), who said the measure would harm the tobacco industry in her home state (Armstrong, CQ HealthBeat, 5/19). The panel"s other member from North Carolina, Sen. Richard Burr (R), said he would filibuster the bill. He said, "I put my fellow senators on notice: This is something that will be a much longer time on the floor than it will be in this hearing" (CongressDaily, 5/20). The committee plans to continue marking up the bill Wednesday and possibly Thursday.The Obama administration has expressed its support for the bill (CQ HealthBeat, 5/19). FDA Commissioner Margaret Hamburg also has said her agency should regulate tobacco (Armstrong, CQ HealthBeat, 5/18).
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Lytix Biopharma And KAEL-GemVax Announce Joint Clinical Trial To Combine LTX-315 And GV1001 Cancer Immunotherapy

The Norwegian biopharmaceutical company Lytix Biopharma and Korean company KAEL-GemVax announced the signing of a collaborative agreement to test lead compounds LTX-315 and GV1001 as a combination therapy for the treatment of cancer. According to Lytix Biopharma CEO Gunnar Saelid and KAEL-GemVax CEO Jay Sangjae Kim, "We are delighted to announce this joint venture to test a combination of two very interesting experimental drugs. In preclinical models, LTX-315 has demonstrated the ability to effect necrotic killing of cancer cells. Simulatenously it also causes the release of warning signals from the stressed and dying cells that trigger activation of the immune system. On the other hand GV1001, a telomerase peptide vaccine in phase III trials, is one of the best documented anti-cancer vaccines currently in development, with a potentially broad utility against a range of cancer types. "There is a strong scientific rationale for combining these agents, providing a local inflammatory response combined with specific vaccination - these two novel agents should have the potential to function as an efficient immunotherapy for the treatment of cancer," says Mr Jon Amund Eriksen, Director of Product Development, Oncology at Lytix Biopharma. Mr Eriksen is also one of the key persons, together with Professor Gustav Gaudernack, at the Norwegian Radium Hospital involved in the development of GV1001. Speaking on behalf of their respective companies, business development spokespeople Anders Fugelli (Lytix Biopharma) and Michelle Kyunghee Kim (KAEL-GemVax) comment, "KAEL-GemVax and Lytix Biopharma will both contribute scientific and regulatory, as well as financial, support to the planned study in patients, sharing the results for use in the future clinical development programs for each proprietary agent. Lytix Biopharma will be responsible for the design, set-up and conduct of the clinical study, which will run at the University Hospital of Northern Norway in Tromso. No further business commitments have been made at this stage." The clinical phase I study will document the utility of LTX-315 as an immune stimulator in patients vaccinated with GV1001, a vaccine directed against the catalytic subunit of human telomerase. Telomerase is a universal tumour antigen expressed in 85-90% of cancer tissues. Lytix Biopharma AS


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