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Article demonstrates single agent activity of KRX-0401 in neuroblastoma tumor preclinical models

Keryx Biopharmaceuticals today announced the publication of an article in the May 12th Journal of the National Cancer Institute, entitled "In Vitro and In Vivo Inhibition of Neuroblastoma Tumor Cell Growth by AKT Inhibitor Perifosine," demonstrating the single agent activity of KRX-0401 (perifosine) in neuroblastoma tumor preclinical models.

18 May 2010

Teva agrees to settle patent litigation regarding generic version of AstraZeneca's Entocort EC capsules

Teva Pharmaceutical Industries Ltd. announced today that it has entered into an agreement with AstraZeneca to settle patent litigation regarding Teva's U.S. generic version of AstraZeneca's Entocort EC (budesonide) capsules.

18 May 2010

Pfizer, Washington University announce indications discovery collaboration

In a first-of-a-kind collaboration between academia and industry, Pfizer Inc. will give scientists at Washington University School of Medicine in St. Louis unprecedented access to information regarding more than 500 pharmaceuticals and pharmaceutical candidates in a partnership that focuses on discovering new uses for existing compounds.

18 May 2010

AbstralTM continues strong growth of over 40% in first-quarter 2010

Orexo AB today confirms that its partner, ProStrakan Group plc has announced that AbstralTM continues to show strong sales development in 2010.

18 May 2010

University of Leeds researchers identify natural defence mechanism against heart disease

A natural defence mechanism against heart disease could be switched on by steroids sold as health supplements, according to researchers at the University of Leeds.

18 May 2010

FDA accepts for filing Sigma-Tau Pharmaceuticals' cysteamine hydrochloride ophthalmic solution NDA

Sigma-Tau Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the company's new drug application (NDA) for its cysteamine hydrochloride ophthalmic solution, an investigational therapy for the treatment of corneal cystine crystals in patients with cystinosis. The FDA also granted the NDA Priority Review status, a designation given to drugs that may provide major advances or a treatment where no adequate therapy exists.

18 May 2010

Final data from Open-Label studies of Cinryze in patients with HAE now available

ViroPharma Incorporated today announced the availability of final data from Open-Label studies of Cinryze (C1 Esterase Inhibitor [Human]) in preventing and treating attacks of hereditary angioedema on the U.S. National Institutes of Health's online clinical trial registry, www.clinicaltrials.gov.

18 May 2010

Sagent Pharmaceuticals recalls metronidazole injection

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL (NDC number 25021-131-82) manufactured by Claris Lifesciences and distributed by Sagent.

18 May 2010

MorphoSys AG (DE) - AbD Serotec enters new growth area

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its research and diagnostic antibody unit AbD Serotec is active in a new growth area.

18 May 2010

FDA issues complete response letter for roflumilast NDA

Forest Laboratories, Inc. and Nycomed today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast. Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

18 May 2010

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

ROXRO PHARMA, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SPRIX™ (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

17 May 2010

Halozyme announces voluntary HYLENEX product recall

Halozyme Therapeutics, Inc. today announced that Halozyme and Baxter have confirmed the presence of small flake-like glass particles in a limited number of vials of HYLENEX® (hyaluronidase human injection) product at the Baxter manufacturing facility. Earlier today, Halozyme notified the U.S. Food and Drug Administration that it is voluntarily recalling affected lots of 150U HYLENEX product from distribution.

17 May 2010

NanoViricides signs Research Agreement with UCSF for testing anti-HIV drug candidates

NanoViricides, Inc., announced that it has signed a Research Agreement with the University of California, San Francisco for testing of its anti-HIV drug candidates. Cheryl Stoddart, PhD, Assistant Professor in the UCSF Division of Experimental Medicine, will be the Principal Investigator.

17 May 2010

Aeterna Zentaris' AEZS-108 receives orphan medicinal product designation for ovarian cancer in Europe

Aeterna Zentaris Inc. a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received a positive opinion for orphan medicinal product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for its compound AEZS-108 for the treatment of ovarian cancer. AEZS-108, the Company's doxorubicin targeted conjugate compound, is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.

17 May 2010

Polypill to be tested in new heart disease trial

Researchers will be exploring whether a new, very low cost, one-a-day combined 'polypill' could reduce the risk of heart attacks, strokes and other cardiovascular problems across the world, in a major new international trial that launches today.

17 May 2010

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

Halozyme Therapeutics, Inc. today announced the delivery of a notice of breach to Baxter Healthcare Corporation due to Baxter's failure to provide HYLENEX (hyaluronidase human injection) in accordance with the terms of the parties' existing development and supply contracts.

17 May 2010

Statins may play role in lowering risk of clot-related diseases: Study

Individuals at risk for clot-related diseases may benefit from taking common cholesterol-lowering drugs known as statins, according to a study conducted by researchers at the University of Connecticut.

17 May 2010

Long-term, regular use of vitamin E in women may help decrease risk of COPD: Study

Long-term, regular use of vitamin E in women 45 years of age and older may help decrease the risk of chronic obstructive pulmonary disease by about 10 percent in both smokers and non-smokers, according to a study conducted by researchers at Cornell University and Brigham and Women's Hospital.

17 May 2010

Amended class action complaint against Pfizer

Robbins Geller Rudman & Dowd LLP ("Robbins Geller") today announced that an amended class action complaint will be filed in the United States District Court for the Southern District of New York. The amended complaint will be on behalf of purchasers of Pfizer Inc. publicly traded securities during the period between January 19, 2006 and January 23, 2009.

15 May 2010

Protox announces positive top-line results from the TRIUMPH study in first quarter 2010

Protox Therapeutics Inc. a leader in the development of receptor targeted fusion proteins, today released financial results for the first quarter 2010, ended March 31, 2010. "The first quarter of 2010 marked significant achievements for the company, namely the announcement of positive top-line results from the TRIUMPH study and the subsequent completion of a five million dollar financing," said Dr. Fahar Merchant, President and CEO of Protox.

15 May 2010

Pharmaceutical News

Article demonstrates single agent activity of KRX-0401 in neuroblastoma tumor preclinical models

Teva agrees to settle patent litigation regarding generic version of AstraZeneca's Entocort EC capsules

Pfizer, Washington University announce indications discovery collaboration

AbstralTM continues strong growth of over 40% in first-quarter 2010

University of Leeds researchers identify natural defence mechanism against heart disease

FDA accepts for filing Sigma-Tau Pharmaceuticals' cysteamine hydrochloride ophthalmic solution NDA

Final data from Open-Label studies of Cinryze in patients with HAE now available

Sagent Pharmaceuticals recalls metronidazole injection

MorphoSys AG (DE) - AbD Serotec enters new growth area

FDA issues complete response letter for roflumilast NDA

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

Halozyme announces voluntary HYLENEX product recall

NanoViricides signs Research Agreement with UCSF for testing anti-HIV drug candidates

Aeterna Zentaris' AEZS-108 receives orphan medicinal product designation for ovarian cancer in Europe

Polypill to be tested in new heart disease trial

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

Statins may play role in lowering risk of clot-related diseases: Study

Long-term, regular use of vitamin E in women may help decrease risk of COPD: Study

Amended class action complaint against Pfizer

Protox announces positive top-line results from the TRIUMPH study in first quarter 2010

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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