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U.S. healthcare practitioners can resume use of Rotarix, says FDA

GlaxoSmithKline announced that the Food and Drug Administration has determined that U.S. healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA's recommendation from March 22, 2010 and reflects the agency's assessment that the presence of porcine circovirus type 1 in the vaccine poses no safety risk.

15 May 2010

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.

15 May 2010

FDA grants tentative approval for Teva's Cinacalcet HCl Tablets ANDA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cinacalcet HCl Tablets 30, 60 & 90 mg.

15 May 2010

CSL Behring donates life-saving medicines to assist earthquake victims in Haiti

Direct Relief International announced today that CSL Behring has donated life-saving medicines valued at more than $100,000 to assist earthquake victims in Haiti who are at risk of tetanus or hepatitis B infections. The products will be used in clinics at Hopital Albert Schweitzer in Deschapelles.

14 May 2010

BioSante Pharmaceuticals first-quarter net loss increases to $10.5 million

BioSante Pharmaceuticals, Inc. today reported on its recent developments and financial results for the first quarter, and its cash balance as of March 31, 2010.

14 May 2010

Hana Biosciences reports $5.5 million net loss for first-quarter 2010

Hana Biosciences Inc.,, a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.

14 May 2010

FDA grants tentative approval for Impax Laboratories' generic Opana ER

Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Opana® ER (oxymorphone hydrochloride) 5, 7.5, 10, 15, 20, 30 and 40 mg tablets.

14 May 2010

Revolutionary technology to protect skin stem cells and combat chronological aging

Emerge Labs presents a revolutionary technology that protects skin stem cells and combats chronological aging. The breakthrough patent-pending active ingredient, PhytoCellTec Solar Vitis, boosts the production of human skin stem cells, protects human skin stem cells against UV radiation, and fights photo-aging, thus decreasing wrinkles and producing younger, fresher looking skin.

14 May 2010

Multivitamin and mineral supplements improve mood, mental performance in healthy males: Study

The effects of multivitamins are most often researched in the elderly. This is one of very few studies to assess the relationship between supplementation with vitamins/minerals and psychological functioning in healthy groups of non-elderly adults. This study shows how a proprietary multivitamin and mineral supplement improves mood and mental performance while also reducing stress, mental tiredness and fatigue in healthy males.

14 May 2010

NanoViricides signs research and development agreement with Dr. Ken S. Rosenthal's laboratory

NanoViricides, Inc., reports that it has signed a research and development agreement with Dr. Ken S. Rosenthal's laboratory at Northeastern Ohio Universities Colleges of Medicine and Pharmacy.

14 May 2010

BioTrends reports increase in usage of Actemra for RA

BioTrends is pleased to announce the publication of the second wave of a syndicated report, LaunchTrends®: ACTEMRA. Actemra (tocilizumab), marketed by Roche-Genentech, is the first IL-6 receptor inhibitor agent approved for rheumatoid arthritis (RA). This report is the second in a three-wave series derived from on-line survey responses from 80 rheumatologists and qualitative interviews with 20 rheumatologists.

14 May 2010

Off-label use of AAs among elderly associated with increased risk of diabetes: Study

A new study yields important new evidence that the use of atypical antipsychotics among the elderly for off-label purposes is associated with increased risk of developing diabetes.

14 May 2010

EPA continues to validate ToxCast screening tool by testing more than 100 drugs

The U.S. Environmental Protection Agency will continue validating its ToxCast screening tool by screening more than 100 drugs provided by Pfizer, GlaxoSmithKline, Sanofi-Aventis, and Merck. These drugs never entered the marketplace because they demonstrated different types and levels of toxicity when the pharmaceutical companies conducted the early stage clinical trials required by the Food and Drug Administration as part of the drug development process.

14 May 2010

India, Brazil launch trade dispute against EU, Netherlands over seizures of generic drugs

"India and Brazil launched a trade dispute against the European Union and the Netherlands on Wednesday, saying their seizures of generic drugs were hurting healthcare in poor countries and disrupting international trade," Reuters reports.

14 May 2010

Opexa Therapeutics reports lower net loss of $1.4M for first-quarter 2010

Opexa Therapeutics, Inc., a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2010 and provided an update on its corporate developments.

14 May 2010

Novel vaccines for deadly diseases to be presented at AAPS' NBC

Novel vaccines for diseases ranging from the flu to HIV highlight a week's worth of biotechnology research at the American Association of Pharmaceutical Scientists' National Biotechnology Conference. Scientists from academia, industry, and government will gather at the Hilton San Francisco Union Square Sunday, May 16 -Thursday, May 20 to share research and advances in biotherapeutics.

14 May 2010

International study to test effectiveness of celecoxib in preventing growth of precancerous polyps

Rush University Medical Center is testing whether celecoxib, known by its brand name Celebrex, can help prevent the growth of precancerous polyps that form in the colon, rectum and small intestine of children with an inheritable genetic disease called familial adenomatous polyposis.

14 May 2010

Pharmaceutical News

U.S. healthcare practitioners can resume use of Rotarix, says FDA

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

FDA grants tentative approval for Teva's Cinacalcet HCl Tablets ANDA

CSL Behring donates life-saving medicines to assist earthquake victims in Haiti

BioSante Pharmaceuticals first-quarter net loss increases to $10.5 million

Hana Biosciences reports $5.5 million net loss for first-quarter 2010

FDA grants tentative approval for Impax Laboratories' generic Opana ER

Revolutionary technology to protect skin stem cells and combat chronological aging

Multivitamin and mineral supplements improve mood, mental performance in healthy males: Study

NanoViricides signs research and development agreement with Dr. Ken S. Rosenthal's laboratory

BioTrends reports increase in usage of Actemra for RA

Off-label use of AAs among elderly associated with increased risk of diabetes: Study

EPA continues to validate ToxCast screening tool by testing more than 100 drugs

India, Brazil launch trade dispute against EU, Netherlands over seizures of generic drugs

Opexa Therapeutics reports lower net loss of $1.4M for first-quarter 2010

Novel vaccines for deadly diseases to be presented at AAPS' NBC

International study to test effectiveness of celecoxib in preventing growth of precancerous polyps

Rotavirus vaccination associated with decline in U.S. hospitalization rates for acute gastroenteritis: Study

Report of 2009 H1N1 influenza VLP vaccine published online

Immunosuppressive drug sirolimus improves kidney health of patients with ADPKD: Study

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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