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Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Clinical Data, Inc., today announced that Santen Pharmaceutical Co., Ltd., has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Clinical Data's highly selective adenosine A2A agonist, ATL313, for the indication of primary open angle glaucoma and ocular hypertension.

From Santen Pharmaceutical Co., Ltd. 23 Dec 2010

Key to long-term weight-loss success is finding unique individual level of carbohydrate tolerance

Recent media coverage suggests that the reported wedding diet of Carole Middleton, mother of future British princess Kate Middleton, is something brand new. Yet the Dukan Diet is just another variation of the Atkins Diet™, but with some nutritional recommendations that simply don't make sense or are guaranteed to fail.

23 Dec 2010

Congress approves stopgap spending measure; Some funding for federal agencies, global health programs delayed

Congress Tuesday "approved a temporary spending bill [.pdf] that will fund the federal government for another 10 weeks through March 4 in order to avoid a government shutdown," Agence France-Presse reports.

23 Dec 2010

AADR testifies at FDA Advisory Panel meeting on dental amalgam

On December 14-15, 2010, the U.S. Food and Drug Administration (FDA) convened an Advisory Panel to discuss several scientific issues that may affect the regulation of dental amalgam. At the conclusion of the hearing, the Panel voted to recommend that the FDA conduct further review of the material's safety.

23 Dec 2010

Funding bill passed; Food safety measure sent to President; 9/11 worker legislation still held up

Although Congress gave approval to a short-term funding measure for the federal government, the bill doesn't contain money to pay for enforcement of new health law regulations. Meanwhile, work continued on other pending proposals.

23 Dec 2010

Pfizer seeks FDA and EMA approval for expanded use of Prevnar 13 for pneumococcal disease

Pfizer Inc today announced that it has submitted supplemental applications to both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand the use of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) to adults 50 years of age and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine.

23 Dec 2010

Researchers find 37° C body temperature is warm enough to ward off fungal infection

Two researchers at Albert Einstein College of Medicine of Yeshiva University have found that our 98.6° F (37° C) body temperature strikes a perfect balance: warm enough to ward off fungal infection but not so hot that we need to eat nonstop to maintain our metabolism.

23 Dec 2010

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

Abbott, AstraZeneca discontinue CERTRIAD development collaboration

Abbott announced today that Abbott and AstraZeneca will discontinue their joint collaboration for the development of CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules.

23 Dec 2010

FDA approves Gardasil for prevention of anal cancer

The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

23 Dec 2010

Opinions: U.S. foreign aid; Malaria eradication; Moving Haiti forward; Health care financing

"At this critical time when we are concerned about our country's financial well being it is imperative that we curtail our charity to others," Bradley Blakeman, deputy assistant to former President George W. Bush and professor of politics and public policy at Georgetown University, writes in a Fox News opinion piece calling for the U.S., which he says "has done more than its fair share for others since our birth as a nation," to "curtail our foreign aid."

23 Dec 2010

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

Today's Opinions: Congressional funding vote leaves out health law; Price controls on health; Tough choices in Washington State

The Senate passed the Continuing Resolution 79-16 this afternoon. Another way of saying that: The Senate voted to defund the implementation of both health-care reform and financial-regulation reform.

23 Dec 2010

FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

People with high RBC folate levels more likely to have two tumor-suppressing genes

People with higher levels of folate in their red blood cells were more likely to have two tumor-suppressing genes shut down by methylation, a chemical off switch for genes, researchers report in the December issue of Cancer Prevention Research.

22 Dec 2010

FDA joins Abbott Diabetes Careto to recall 359 glucose test strips

The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient's health.

22 Dec 2010

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, today announced the filing of a New Drug Application with the U.S. Food and Drug Administration for Anturol Gel in patients with overactive bladder.

22 Dec 2010

New era for anticoagulant therapy

In a Guest Editorial published in the new publication Clinical Investigation, Dr Jeffrey Weitz and Dr John Eikelboom of McMaster University in Hamilton, Canada highlight the importance of the approval in October by the FDA of dabigatran etexilate (Pradaxa®; Boehringer Ingelheim). This new oral thrombin inhibitor provides an alternative to warfarin for long-term stroke prevention in patients with non-valvular atrial fibrillation.

22 Dec 2010

Millennia compiles data on 100 wounds treated with Cytomedix AutoloGel System

Cytomedix, Inc. a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that its Japanese partner, Millennia Holdings, Inc. ("Millennia"), has compiled data on 100 wounds treated with the Company's AutoloGel™ System, and will use this initial data to support its regulatory and reimbursement filings in Japan. The full data set is expected to be released through presentations at scientific and medical meetings and through publication in a peer-reviewed journal.

22 Dec 2010

Food News and Research

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Key to long-term weight-loss success is finding unique individual level of carbohydrate tolerance

Congress approves stopgap spending measure; Some funding for federal agencies, global health programs delayed

AADR testifies at FDA Advisory Panel meeting on dental amalgam

Funding bill passed; Food safety measure sent to President; 9/11 worker legislation still held up

Pfizer seeks FDA and EMA approval for expanded use of Prevnar 13 for pneumococcal disease

Researchers find 37° C body temperature is warm enough to ward off fungal infection

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Abbott, AstraZeneca discontinue CERTRIAD development collaboration

FDA approves Gardasil for prevention of anal cancer

Opinions: U.S. foreign aid; Malaria eradication; Moving Haiti forward; Health care financing

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today's Opinions: Congressional funding vote leaves out health law; Price controls on health; Tough choices in Washington State

FDA approves Watson's novel oral contraceptive

People with high RBC folate levels more likely to have two tumor-suppressing genes

FDA joins Abbott Diabetes Careto to recall 359 glucose test strips

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

New era for anticoagulant therapy

Millennia compiles data on 100 wounds treated with Cytomedix AutoloGel System

Understanding cultivated meat and its global potential eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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