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ISTA Pharmaceuticals' sNDA for once-daily XiDay: FDA assigns PDUFA action date

ISTA Pharmaceuticals, Inc., today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay™ (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA).

8 Mar 2010

Prostate-specific dietary supplements discouraged during radiation therapy treatments: Study

Prostate-specific dietary supplements should not be taken during radiation therapy treatments because they have been shown to increase the radiosensitivity of normal prostate cell lines, leading to normal tissue complications, according to a study in the March issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of the American Society for Radiation Oncology.

8 Mar 2010

FDA approves Taro Pharmaceutical Industries' Fluorouracil Topical Cream ANDA

Taro Pharmaceutical Industries Ltd. today reported that it received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Fluorouracil Topical Cream USP, 5%.

8 Mar 2010

BioSpecifics Technologies' XIAFLEX now available to Dupuytren's contracture patients in the U.S.

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that XIAFLEX™ is now available in the U.S. by prescription, for the treatment of adult Dupuytren's contracture patients with a palpable cord. Dupuytren's contracture is a debilitating disease resulting from excessive collagen deposition that causes contractures of the fingers.

8 Mar 2010

Ricerca Biosciences to acquire Discovery and Preclinical business of MDS Pharma Services

Ricerca Biosciences, LLC, announced today the finalization of the acquisition of the Discovery and Preclinical business of MDS Pharma Services with facilities and almost 600 associates in Bothell, Washington; Lyon, France; and Taipei, Taiwan.

8 Mar 2010

New nutrition product to address effects of Glycation

After an extensive on going research program, Mineral BioSciences LLC a division of Global Organics Group is proud to announce the introduction of TOTALA® Nutrients, an ingredient that promises to have a profound effect on the nutrition industry.

8 Mar 2010

NICE rejects azacitidine for treatment of MDS in patients ineligible for stem cell transplants

A drug for treating a group of conditions that affect the bone marrow is unlikely to be made available on the NHS in England and Wales after the body which provides independent advice on treatments said that it is unlikely to be cost-effective.

8 Mar 2010

NerPharMa facility receives FDA approval to manufacture CTI's drug pixantrone

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product.

8 Mar 2010

U-M scientists identify new reservoir for hidden HIV-infected cells that can serve as factory for new infections

University of Michigan scientists have identified a new reservoir for hidden HIV-infected cells that can serve as a factory for new infections. The findings, which appear online March 7 in Nature Medicine, indicate a new target for curing the disease so those infected with the virus may someday no longer rely on AIDS drugs for a lifetime.

8 Mar 2010

Scientists show Ritalin boosts cognitive abilities by enhancing brain plasticity

Doctors treat millions of children with Ritalin every year to improve their ability to focus on tasks, but scientists now report that Ritalin also directly enhances the speed of learning.

8 Mar 2010

Leadership challenges and best practices in dealing with FDA’s REMS

Three pharmaceutical executives with extensive experience in dealing with the FDA’s Risk Evaluation and Mitigation Strategy (REMS) will share their thoughts and practices at an open industry webinar at 12 noon EST on Wednesday, March 10, sponsored by ParagonRx.

6 Mar 2010

Nordic Naturals' products surpass all PCB standards set by California's Proposition 65

Nordic Naturals announced today that the company's products surpass all PCB standards set by California's Proposition 65, the GOED voluntary monograph, and all international standards. Nordic Naturals products were not listed in the lawsuit filed in California alleging that eight fish oil companies did not properly label products regarding PCB levels under the state's Proposition 65.

6 Mar 2010

Abt Associates receives two new contracts to evaluate effectiveness of H1N1 vaccine

The Centers for Disease Control and Prevention has awarded Abt Associates two new contracts to evaluate the effectiveness of the H1N1 vaccine among health care workers and children under the age of 18.

6 Mar 2010

Peptimmune granted US patent for PI-2301 peptide copolymer in treatment of multiple sclerosis

Peptimmune, Inc. a privately held biotechnology company, announced today the grant of US Patent Number 7,655,221 (the '221 patent) which protects the target product profile for its PI-2301 peptide copolymer for the treatment of multiple sclerosis, and other autoimmune diseases.

6 Mar 2010

Lancet World Report examines GAVI's funding gap

Lancet World Report examines the challenges ahead for the GAVI Alliance, which after a decade of "steadily increasing financing" is now "facing a funding shortfall for the next decade that could hamper the roll-out of new vaccines." GAVI leaders attribute the funding challenges to the global economic crisis, which has kept government aid budgets from increasing, according to the Lancet.

6 Mar 2010

Soluble Systems, SWAI launch TheraSkin to jumpstart healing in chronic and acute wounds

Soluble Systems, LLC and the Skin and Wound Allograft Institute, a wholly owned subsidiary of LifeNet Health, have signed a noteworthy agreement to launch TheraSkin™, a biologically active human skin allograft designed to jumpstart healing in chronic and acute wounds.

6 Mar 2010

Hypertension: Regular nifedipine administration may lead to development of GERD

Nifedipine, a calcium-channel blocker, was shown to decrease lower esophageal sphincter pressure and increase esophageal acid exposure time, while atenolol, a b1 blocker, was shown to inhibit relaxation of the smooth muscle of the esophagus. However, the influence of these anti-hypertensive drugs on the segment of esophageal body contraction using high-resolution manometry was not fully investigated.

5 Mar 2010

New anti-tumour vaccine for mesothelioma shows promising results

A vaccine against mesothelioma, a cancer associated with exposure to asbestos, has shown early promise in its first clinical trial.

5 Mar 2010

Varian launches next generation dissolution apparatus

Varian, Inc. announced today the availability of its next generation dissolution apparatus designed for testing tablets, capsules and other dosage forms. The 708-DS supports a broad set of applications ranging from manual dissolution testing to automated, high-throughput analysis. It provides extensive flexibility to match the needs of individual laboratories, whether in research or testing. Integration with either the new Varian UV or LC Dissolution Systems will save time and reduce the potential for sample handling errors.

5 Mar 2010

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. The proposed trade name for pirfenidone is Esbriet®.

5 Mar 2010

Pharmaceutical News

ISTA Pharmaceuticals' sNDA for once-daily XiDay: FDA assigns PDUFA action date

Prostate-specific dietary supplements discouraged during radiation therapy treatments: Study

FDA approves Taro Pharmaceutical Industries' Fluorouracil Topical Cream ANDA

BioSpecifics Technologies' XIAFLEX now available to Dupuytren's contracture patients in the U.S.

Ricerca Biosciences to acquire Discovery and Preclinical business of MDS Pharma Services

New nutrition product to address effects of Glycation

NICE rejects azacitidine for treatment of MDS in patients ineligible for stem cell transplants

NerPharMa facility receives FDA approval to manufacture CTI's drug pixantrone

U-M scientists identify new reservoir for hidden HIV-infected cells that can serve as factory for new infections

Scientists show Ritalin boosts cognitive abilities by enhancing brain plasticity

Leadership challenges and best practices in dealing with FDA’s REMS

Nordic Naturals' products surpass all PCB standards set by California's Proposition 65

Abt Associates receives two new contracts to evaluate effectiveness of H1N1 vaccine

Peptimmune granted US patent for PI-2301 peptide copolymer in treatment of multiple sclerosis

Lancet World Report examines GAVI's funding gap

Soluble Systems, SWAI launch TheraSkin to jumpstart healing in chronic and acute wounds

Hypertension: Regular nifedipine administration may lead to development of GERD

New anti-tumour vaccine for mesothelioma shows promising results

Varian launches next generation dissolution apparatus

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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