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Acura And King Receive FDA Complete Response Letter Regarding Acurox(R)
Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain.
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Obama's Notre Dame Speech Strikes 'Forceful Blow' Against Culture Wars, Washington Post Opinion Piece Says
President Obama during his speech at Notre Dame, "fought back" antiabortion-rights protesters "not with harsh words but with the most devastating weapons in his political arsenal: a call for "open hearts," "open minds," "fair-minded words" and a search for "common ground,"" Washington Post columnist E.J. Dionne writes. Dionne continues that as "Obama"s opponents seek to reignite the culture wars," the president has "refused to join" and instead "opted for humility." Dionne writes that Obama "did all this without skirting the abortion question and without flinching from the "controversy surrounding my visit here."" In what might have been Obama"s "most radical and the most conservative speech of his presidency," he "[a]cknowledg[ed] the Roman Catholic Church"s role in supporting his early community organizing work," while drawing "on the res of Catholic social thought" that "combines opposition to abortion with a sharp critique of economic injustice and thus doesn"t squeeze into the round holes of contemporary ideology," according to Dionne.In his speech, Obama "tried to undo mistakes made early in his administration, making clearer, for example, that his revisions of an earlier Bush executive order on the rights of health professionals would continue to "honor the conscience of those who disagree with abortion,"" Dionne continues. In addition, Obama "paid more respect to opponents of stem cell research -- he spoke of their "admirable conviction about the sacredness of life" -- than he had in his original announcement altering Bush"s policies," Dionne writes. He adds that on the issue of abortion rights, "Obama endorsed a broad agenda: "Let"s reduce unintended pregnancies. Let"s make adoption more available. Let"s provide care and support for women who do carry their children to term.""However, it "was hard to square that message with the rage directed toward Obama" and Notre Dame"s president, the Rev. John Jenkins, by their opponents, Dionne says. "By facing their arguments head-on and by demonstrating his attentiveness to Catholic concerns, Obama strengthened moderate and liberal forces inside the church itself," according to Dionne. He concludes, "He also struck a forceful blow against those who would keep the nation mired in culture-war politics without end. Obama"s opponents on the Catholic right placed a large bet on his Notre Dame visit. And they lost" (Dionne, Washington Post, 5/18).
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NICE Announces Review Of Its Skin Cancer Guidance
The National Institute for Health and Clinical Excellence (NICE) has announced that it will convene a guidance development group to formally review the recommendations relating to the diagnosis and removal of "low risk" basal cell carcinomas (BCCs) in primary care in its guidance Improving Outcomes in Cancer for people with skin tumours including melanoma (2003).
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BioLineRx Announces Positive Preliminary Results From The Phase I/II Trial Of BL-1040

BioLineRx Ltd. (TASE:BLRX), a clinical stage drug development company, today announced positive preliminary results from the ongoing phase I/II clinical trial designed to assess the safety and feasibility of BL-1040, the first injectable device designed to address cardiac remodeling, in 20- 30 patients at several sites in Germany and Belgium. To date, 15 patients were successfully treated with BL-1040 with no complications. Moreover, six months follow up results from the first 5 patients show BL-1040"s efficacy in preventing cardiac remodeling and preserving cardiac function. BL-1040 represents a breakthrough approach to supporting cardiac tissue damaged as a result of acute myocardial infarction (MI), improving cardiac function and survival. BL-1040 is a resorbable liquid polymer that is administered via the coronary artery during standard catheterization and flows into the damaged heart muscle. BL-1040 undergoes a liquid to gel phase transition within the infarcted cardiac tissue and forms a protective "scaffold" that enhances the mechanical strength of the heart muscle during recovery and repair, thereby preventing pathological enlargement of the left ventricle after the MI. BL-1040 is excreted naturally from the body within six weeks after injection, leaving behind a stronger, more stable heart muscle. The safety, biocompatibility and efficacy of BL-1040 were demonstrated in pre-clinical studies performed in multiple species. BL-1040 was shown to prevent wall thinning and stabilize End Systolic Volume (ESV) and Ejection Fraction (EF). Data from the ongoing phase I/II trial confirm these findings. To date, 15 patients suffering from a significant infarction were successfully treated with BL-1040 with no complications, no arrhythmias, no elevations in cardiac enzymes and no occlusions. In addition, six months follow up data from the first 5 patients show that BL-1040 prevented End Systolic and End Diastolic Volume dilation, prevented wall thinning and preserved left ventricular dimensions. It is important to note, that patients enrolled in the study suffered a significant MI and were expected to display wall thinning and volume dilations. "BL-1040 could revolutionize the treatment of patients recovering from a massive heart attack," said Professor Jonathan Leor, Director of the Neufeld Cardiac Research Institute at Tel-Aviv University, Israel who invented BL-1040 and conducted the initial experiments together with Professor Smadar Cohen from Ben Gurion University, Israel. "We look forward to completing the trial and believe that it will continue to provide more evidence for the success of our new approach to bring effective and safe treatment for patients with injured hearts," added Professor Leor. "This is an important milestone in the development of BL-1040, BioLineRx"s innovative product candidate, which is the first treatment that attempts to treat damaged cardiac tissue resulting from an acute MI and addresses a tremendous unmet medical need," said Morris C. Laster, MD, CEO of BioLineRx. BL-1040 was in-licensed by BioLineRx from Ben-Gurion University through BGN Technologies, and it was developed by Professor Smadar Cohen and Professor Jonathan Leor from Tel Aviv University. For further information on BL-1040, please visit the BioLineRx website and BL-1040 animation at http://www.biolinerx.com/PipelineSelected.asp About Acute Myocardial Infarction Acute MI is a leading cause of morbidity and mortality in the Western world. Approximately 1.3 million cases of nonfatal MI are reported each year in the U.S. alone, with an annual incidence rate of approximately 600 cases per 100,000 people. BioLineRx


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