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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

Echo Therapeutics first-quarter net loss increases to $1.9 million

Echo Therapeutics, Inc., a company developing its needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude™ SkinPrep System for transdermal drug delivery, today announced financial results for the period ended March 31, 2010.

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

Is gluten the latest villain in the battle for better health?

If you've been food shopping or out to eat lately, you've probably noticed that "gluten-free" foods now claim their own grocery store shelves and dozens of national restaurant chain menus highlight "gluten-free" entrees.

17 May 2010

USAID's Shah on six-day visit to Africa

"[O]n his first visit to Africa since taking charge as the administrator of USAID in January," Rajiv Shah said in Nairobi, Kenya on Saturday that the agency "is working to make Africa a bigger priority within the organization," the Associated Press writes. USAID, which "funds and runs programs to improve health, food security, democracy and entrepreneurship in Africa," has offices in 23 countries on the continent, according to the AP (5/15).

17 May 2010

Emisphere Technologies first-quarter net loss increases to $18.5 million

Emisphere Technologies, Inc. today announced its financial results for the first quarter 2010.

17 May 2010

FDA grants NeoPharm's IL13-PE38QQR orphan-drug designation for treatment of IPF

NeoPharm, Inc., announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan-drug designation for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

17 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

ARCA biopharma announces SPA agreement with FDA for bucindolol clinical trial

ARCA biopharma, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is the Company's investigational, pharmacologically unique, beta-blocker and mild vasodilator.

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

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Emergent BioSolutions Inc. announced today that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration (FDA) review. The Phase I study will evaluate the safety and pharmacokinetics of the company's fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent's monoclonal antibody was found to be effective.

17 May 2010

Tiens Biotech first-quarter revenues decrease to $11.4 million

Tiens Biotech Group (USA), Inc.,, today announced financial results for the first quarter ended March 31, 2010.

17 May 2010

Biostar Pharmaceuticals first-quarter 2010 revenues increase 66.0% to $12.4 million

Biostar Pharmaceuticals, Inc., a Xianyang- based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsules, and a variety of pharmaceutical products, today announced financial results of the first quarter ended March 31, 2010.

17 May 2010

Tranzyme Pharma to present data on prokinetic agent TZP-101 in GI recovery at ASCRS 2010

Tranzyme Pharma today announced that Philippa Charlton, MD, Tranzyme's Medical Director, and her colleagues G. Bochicchio, J.C. Pezullo, G. Kosutic, and A. Senagore, will present a poster entitled "The Prokinetic Agent TZP-101 (a Ghrelin Agonist) Accelerates GI Recovery in Partial Colectomy Patients Independently of Total Opioid Use and Type of Surgery" at the upcoming 2010 Annual Scientific Meeting of the American Society of Colon and Rectal Surgeons (ASCRS; Minneapolis, May 15-19).

17 May 2010

Berman Institute experts available for comment on direct-to-consumer marketing of genetic test kits

Journalists covering the recent announcement by Pathway Genomics that it will sell health-related genetic marker tests to consumers—and the subsequent decision by Walgreens to postpone sales of the kits pending clarification of their legal status—are invited to interview Berman Institute experts Joan Scott or Gail Javitt.

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

High fat diet linked to exacerbation of asthma

In a new study researchers have found a connection between exacerbation of bronchial asthma and high calorie burgers and fries. Diet and lifestyle have been linked to asthma for some time now but this is the first real evidence. With the advent of unhealthy diets the incidence and prevalence of asthma is on the rise. In 2007, about 34.1 million Americans had asthma, according to the American Academy of Allergy, Asthma and Immunology. From 1980 through 1994, the prevalence of asthma increased by 75 percent.

17 May 2010

Scientists find clues to how our brains work

Scientists from The Scripps Research Institute have found a specific chemical compound secreted by many predators that makes mice behave fearfully. The research helps scientists better understand animal behavior, and may eventually lead to new insights into how sensory information is processed in human brains.

17 May 2010