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J&JPRD submits New Drug Application to FDA for rivaroxaban

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

6 Jan 2011

Indian drugmaker seeks to make, sell generic version of Pfizer's HIV drug

The Indian drugmaker Natco Pharma "said Wednesday it has informed Pfizer Inc. that it wants to make and sell a low-cost generic version of the U.S. company's [drug] maraviroc for treating the HIV infection under a so-called 'compulsory license'," Dow Jones Newswires/Smart Money reports.

6 Jan 2011

FDA awards supplemental approval to support efficacy of ACTEMRA in treating RA

Genentech, Inc., a member of the Roche Group, today announced that the United States Food and Drug Administration has extended the ACTEMRA (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis, when given in combination with methotrexate.

6 Jan 2011

Avaxia Biologics generates compelling pre-clinical data in animal models of IBD

Avaxia Biologics, Inc., a privately-held biotech company developing an innovative platform technology to deliver orally-active antibodies to the gastrointestinal tract, announced today that it has generated compelling pre-clinical data in animal models of inflammatory bowel disease.

6 Jan 2011

Water Street Healthcare announces acquisition of OraPharma from Johnson & Johnson

Water Street Healthcare Partners announced today that it has acquired OraPharma, Inc. from Johnson & Johnson. Water Street, a strategic private equity firm focused exclusively on health care, plans to build OraPharma into a leading specialty pharmaceutical company focused on dental and oral health care.

6 Jan 2011

Study: Antibiotics can provide long-lasting relief to patients with irritable bowel syndrome

A ground-breaking antibiotic therapy developed at Cedars-Sinai Medical Center is the first potential drug treatment to provide irritable bowel syndrome patients with long-lasting relief of their symptoms even after they stop taking the medication, according to a study published in the Jan. 6 issue of the New England Journal of Medicine.

6 Jan 2011

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

Ikaria, Inc. today announced that the U.S. Food and Drug Administration has granted INOMAX for inhalation an additional six months of marketing exclusivity, known as "pediatric exclusivity."

6 Jan 2011

Spectrum Pharmaceuticals enters agreement with Viropro to develop biosimilar rituximab

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that it has signed a letter of agreement with Viropro, Inc., for the development of a biosimilar version of the monoclonal antibody drug rituximab (marketed by Genentech/Roche). Worldwide sales of rituximab in 2009 in all indications, including non-Hodgkin's lymphoma and chronic lymphocytic lymphoma, were approximately $5.6 billion.

5 Jan 2011

Tablet splitting leads to inaccurate dosages

Medical experts have issued a warning about the common practice of tablet splitting, after a study found that nearly a third of the split fragments deviated from recommended dosages by 15 per cent or more.

5 Jan 2011

EUSA receives FDA Priority Review status for ERWINAZE BLA

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that its Biologics License Application for ERWINAZE(R) has been accepted for filing and awarded Priority Review status by the U.S. Food and Drug Administration.

5 Jan 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

GLUMETZA tablets are now available to wholesalers and physicians

Santarus, and Depomed, today announced that supply of GLUMETZA® 500 mg to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.

5 Jan 2011

Men are more willing to receive HPV vaccine, trend may help reduce cancer deaths

Men are more willing to receive human papillomavirus vaccine when they learn the vaccine can prevent cancer, according to a recent University of North Carolina at Chapel Hill study.

5 Jan 2011

Indian government rejects Abbott's patent application for second-line ARV

India's patent office "has rejected American drug maker Abbott Laboratories' patent application for an HIV combination drug, allowing low-cost local drug makers to make and sell their generic versions in India and other countries where the medicine is not patented," Economic Times reports (1/4).

5 Jan 2011

Elis granted exclusive rights to market Apricus Bio's Vitaros in the Gulf and part of the Middle East

Apricus Biosciences, Inc. and Elis Pharmaceuticals, announced today that the two companies have entered into a licensing agreement granting Elis the exclusive rights to market Apricus Bio's new drug for erectile dysfunction, Vitaros®, in the Gulf and part of the Middle East. "This new agreement is the next step in our strategy of seeking to partner Vitaros in more than 100 countries around the world," said Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio.

5 Jan 2011

Researchers create model that predicts drug effects on fetal development

When pregnant women need medications, there is often concern about possible effects on the fetus. Although some drugs are clearly recognized to cause birth defects, and others are generally recognized as safe, surprisingly little is known about most drugs' level of risk. Researchers in the Children's Hospital Boston Informatics Program have created a preclinical model for predicting a drug's teratogenicity based on characterizing the genes that it targets.

5 Jan 2011

Dongsheng obtains exclusive sales rights of Thymosin Alpha 1 Injection in China

Dongsheng Pharmaceutical International Co., Ltd. announced today that it has obtained the exclusive sales rights of Thymosin Alpha 1 Injection in 19 provinces in China from Shanghai Biochemistry Pharmaceutical Co. I.

5 Jan 2011

Fruit fly faeces provides answers to pregnant women's bloating and constipation

Clues about how the human gut helps regulate our appetite have come from a most unusual source - fruit fly faeces. Scientists at the University of Cambridge are using the fruit fly to help understand aspects of human metabolism, including why pregnant women suffer from bloating and constipation, and even the link between a low calorie diet and longevity.

5 Jan 2011

Two doses of varicella vaccine provide higher antibody levels than one

When vaccinating children against varicella, researchers at Yale School of Medicine have found, two doses are better than one. In fact, the odds of developing chicken pox were 95 percent lower in children who had received two doses of the vaccine compared with those who had received only one dose.

5 Jan 2011

Researchers develop unique vaccine that produces long-lasting anti-cocaine immunity in mice

Researchers from The Scripps Research Institute, Weill Cornell Medical College, and Cornell University have produced a long-lasting anti-cocaine immunity in mice by giving them a unique vaccine that combines bits of the common cold virus with a particle that mimics cocaine.

5 Jan 2011

Pharmaceutical News

J&JPRD submits New Drug Application to FDA for rivaroxaban

Indian drugmaker seeks to make, sell generic version of Pfizer's HIV drug

FDA awards supplemental approval to support efficacy of ACTEMRA in treating RA

Avaxia Biologics generates compelling pre-clinical data in animal models of IBD

Water Street Healthcare announces acquisition of OraPharma from Johnson & Johnson

Study: Antibiotics can provide long-lasting relief to patients with irritable bowel syndrome

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

Spectrum Pharmaceuticals enters agreement with Viropro to develop biosimilar rituximab

Tablet splitting leads to inaccurate dosages

EUSA receives FDA Priority Review status for ERWINAZE BLA

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

GLUMETZA tablets are now available to wholesalers and physicians

Men are more willing to receive HPV vaccine, trend may help reduce cancer deaths

Indian government rejects Abbott's patent application for second-line ARV

Elis granted exclusive rights to market Apricus Bio's Vitaros in the Gulf and part of the Middle East

Researchers create model that predicts drug effects on fetal development

Dongsheng obtains exclusive sales rights of Thymosin Alpha 1 Injection in China

Fruit fly faeces provides answers to pregnant women's bloating and constipation

Two doses of varicella vaccine provide higher antibody levels than one

Researchers develop unique vaccine that produces long-lasting anti-cocaine immunity in mice

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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