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Dendreon requests licensure for additional capacity to manufacture PROVENGE at New Jersey facility

Dendreon Corporation today announced that it has completed the submission of the post-approval supplement to the PROVENGE® (sipuleucel-T) Biologics License Application for the Morris Plains, New Jersey manufacturing facility. Dendreon is requesting licensure for an additional 36 workstations to manufacture PROVENGE. The standard U.S. Food and Drug Administration (FDA) review for a post-approval supplement to a Biologics License Application is typically four months.

11 Nov 2010

Lemon-lime soft drink could improve effectiveness of oral anticancer drug: Study

Experiments with an artificial stomach suggest that a popular lemon-lime soft drink could play an unexpected role in improving the effectiveness of an oral anticancer drug. The experiments produced evidence that patients will absorb more of the unnamed drug, tested in Phase I in clinical trials, when taken with "flat" or degassed Sprite. The study appears in ACS' Molecular Pharmaceutics, a bi-monthly journal.

11 Nov 2010

PolyMedix receives FDA regulatory clearance for PMX-30063 IND application

PolyMedix, Inc. an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMX-30063, a synthetic defensin-mimetic antibiotic.

11 Nov 2010

Egrifta receives FDA approval for treatment of HIV-lipodystrophy

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

10 Nov 2010

Appeals court upholds five-year exclusivity period for Shire's VYVANSE

Shire plc, the global specialty biopharmaceutical company, announces that the U.S. Court of Appeals for the District of Columbia Circuit has affirmed the ruling of the U.S. District Court for the District of Columbia and the U.S. Food and Drug Administration to grant five-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire U.S. Inc. under the name VYVANSE(R).

10 Nov 2010

Hemispherx Biopharma awarded grant for Ampligen, Alferon development programs

Hemispherx Biopharma, Inc. announced today grant awards totaling $488,958 from the U.S. Department of Treasury in support of its Ampligen and Alferon development programs.

10 Nov 2010

PPIs, antiplatelet drugs can help treat CV disease patients at high risk of upper GI bleeding

Using proton pump inhibitors and antiplatelet drugs (thienopyridines) together is an appropriate way of treating patients with cardiovascular disease who are at high risk of upper gastrointestinal bleeds, despite recent concerns about an adverse interaction between these two types of drugs, according to an Expert Consensus Document released jointly today by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

10 Nov 2010

Omeros identifies orphan GPCR compound that potentiates tumor-killing activity of doxorubicin

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that a compound identified by the Company as an antagonist of GPR87, an orphan GPCR recently unlocked for drug development by Omeros and linked to squamous cell carcinoma, potentiates the tumor-killing activity of doxorubicin (Adriamycin), a widely used chemotherapeutic agent.

10 Nov 2010

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

Covidien, a leading global provider of healthcare products, announced the results of an analysis that will be presented at the American College of Rheumatology's Annual Scientific Meeting. A pooled analysis of safety data suggests that patients with knee osteoarthritis (OA) receiving the topical PENNSAID® (diclofenac sodium topical solution) 1.5% w/w had significantly fewer gastrointestinal (GI)-related adverse events than those receiving an oral non-steroidal anti-inflammatory drug (NSAID).

10 Nov 2010

Women taking HPV vaccine need only two HPV screening tests for rest of their lives: Research

Women who have had the human papillomavirus vaccine could need only two HPV screening tests for the rest of their lives according to new calculations being presented at the NCRI Cancer Conference in Liverpool.

10 Nov 2010

Breast cancer patients more likely to have joint pain from taking AIs: Study

Breast cancer patients are more likely to have joint pain from taking aromatase inhibitors if they have advanced stage cancer, according to a study presented at the American College of Rheumatology's annual meeting, held Nov. 7-11, in Atlanta. The study is one of the first to identify factors that increase the likelihood that a patient will suffer joint pain from AI therapy.

10 Nov 2010

Lower-protein infant formula helps attain same growth rate as breastfed infants

Newly published findings indicate that infants fed a lower protein infant formula developed by Pfizer Nutrition gained weight at a similar rate to those who were breastfed, according to a study published online today in the European Journal of Clinical Nutrition. Pfizer Nutrition has always recognized that breast milk is the best source of infant nutrition. The study established that infants fed a new, lower-protein infant formula attained the same growth rate and growth pattern as breastfed infants.

10 Nov 2010

Using mild painkillers during pregnancy can increase risk of male reproductive disorders

New evidence has emerged that the use of mild painkillers such as paracetamol, aspirin and ibuprofen, may be part of the reason for the increase in male reproductive disorders in recent decades.

10 Nov 2010

Malaria drug artesunate found more effective than quinine at preventing severe falciparum malaria deaths in children, study says

Researchers found that the death rate among children diagnosed with severe falciparum malaria was almost one-fourth lower when they received the drug artesunate rather than the standard treatment of quinine, according to research which was presented at the American Society for Tropical Medicine and Hygiene (ASTMH) over the weekend and published Monday in the Lancet, HealthDay News/U.S. News and World Report writes.

10 Nov 2010

Clot-busting drug remains the most beneficial emergency treatment for strokes

The clot-busting drug rt-PA remains the most beneficial proven emergency treatment for strokes caused by blood clots, according to an editorial in the November issue of Archives of Neurology by Dr. Jos- Biller.

10 Nov 2010

Flu vaccination programs can protect employee health, save businesses money

Each year, influenza poses a tremendous burden on working adults and the many businesses that employ them, contributing to absenteeism and lost productivity. Yet, annual influenza immunization rates remain very low. New data out today show that employer-sponsored influenza vaccination programs held early in the flu season not only protect employee health, but save businesses money.

10 Nov 2010

Restylane boosts people's first impression

A recent study demonstrating that the treatment of nasolabial folds with Restylane positively influences the first impression that an individual projects was published by Dr. Steven Dayan (www.drdayan.com) and DeNova research in the November 2010 issue of Dermatologic Surgery, a leading Dermatology journal. In a study 20 patients received Restylane the popular hyaluronic filler to fill in the nasolabial folds which run from the side of the nose to the side of the mouth.

10 Nov 2010

Aromatase inhibitors increase side effects in women undergoing breast cancer therapy

Women being treated for breast cancer with aromatase inhibitors may experience extremely low estrogen levels resulting in a wide variety of side effects that a typical postmenopausal woman without cancer may not experience.

10 Nov 2010

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP).

10 Nov 2010

Orexo third quarter net revenues decrease to MSEK 35.9

"During the third quarter, Abstral™ sales were 480% higher than in the same period last year. Sales of Edluar™, Orexo's sublingual zolpidem treatment for insomnia, continue to grow more strongly from a low base, with new stock being ordered for the first time since launch and generating royalty income for Orexo.

10 Nov 2010

Pharmaceutical News

Dendreon requests licensure for additional capacity to manufacture PROVENGE at New Jersey facility

Lemon-lime soft drink could improve effectiveness of oral anticancer drug: Study

PolyMedix receives FDA regulatory clearance for PMX-30063 IND application

Egrifta receives FDA approval for treatment of HIV-lipodystrophy

Appeals court upholds five-year exclusivity period for Shire's VYVANSE

Hemispherx Biopharma awarded grant for Ampligen, Alferon development programs

PPIs, antiplatelet drugs can help treat CV disease patients at high risk of upper GI bleeding

Omeros identifies orphan GPCR compound that potentiates tumor-killing activity of doxorubicin

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

Women taking HPV vaccine need only two HPV screening tests for rest of their lives: Research

Breast cancer patients more likely to have joint pain from taking AIs: Study

Lower-protein infant formula helps attain same growth rate as breastfed infants

Using mild painkillers during pregnancy can increase risk of male reproductive disorders

Malaria drug artesunate found more effective than quinine at preventing severe falciparum malaria deaths in children, study says

Clot-busting drug remains the most beneficial emergency treatment for strokes

Flu vaccination programs can protect employee health, save businesses money

Restylane boosts people's first impression

Aromatase inhibitors increase side effects in women undergoing breast cancer therapy

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

Orexo third quarter net revenues decrease to MSEK 35.9

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