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HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

HRA Pharma announced today that the U.S. Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs voted 11 to 0 that the company's application provided sufficient information to conclude that ulipristal acetate is effective and safe for use as an emergency contraceptive.

18 Jun 2010

Fraudulent Tamiflu sold over Internet, FDA warns

The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

18 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

Ricerca announces services under U.S. DEA license

Ricerca Biosciences, an industry-leading, integrated preclinical contract research organization (CRO) providing services to the chemical and biopharmaceutical industries, is pleased to announce services it can now provide under its United States Drug Enforcement Administration (DEA) license.

18 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

FDA approves Jevtana to treat men with prostate cancer

The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

18 Jun 2010

$FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer$

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

18 Jun 2010

Study evaluates effect of Viusid on oxidative stress, cytokine parameters in patients with CHC

The pathogenesis of chronic hepatitis C is associated with severe oxidative stress and non-selective immunological disturbance that lead to necroinflammation and the progression of fibrosis. Several trials have suggested that antioxidant and immunostimulant therapies may have a beneficial effect. Two previous clinical studies have reported that the Viusid related effect on histologic features, especially fibrosis, appears to be associated with antioxidant and/or immunomodulatory properties.

18 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

China Yongxin Pharmaceuticals expands chain of drugstores to 103

China Yongxin Pharmaceuticals Inc., one of the leading health products distribution and retail sales companies in China, today announced the opening of three new chain drugstores in Changchun City. These new openings bring the Company's total number of stores to 24 in Changchun City, and 103 throughout Northeastern China, exceeding the Company's previously projected rate of growth in terms of number of locations.

17 Jun 2010

2009 H1N1 pandemic influenza vaccine protects against 1918 influenza virus: Report

Mice injected with a 2009 H1N1 pandemic influenza vaccine and then exposed to high levels of the virus responsible for the 1918 influenza pandemic do not get sick or die, report scientists funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

17 Jun 2010

Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

Kun Run Biotechnology, Inc., a leading bio-pharmaceutical company in China focusing on manufacturing and sales of peptide-based and small molecule drugs, today announced that they have obtained the manufacturing approval for Entecavir from the China State Food and Drug Administration (SFDA).

17 Jun 2010

Scientific American publishes article on "rebirth" of DNA vaccines

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Scientific American magazine has published in its July issue an article entitled "DNA Drugs Come of Age." The article was co-authored by Dr. David Weiner, Chairman, Scientific Advisory Board, Inovio Pharmaceuticals, and Professor, Department of Pathology & Laboratory Medicine, at the University of Pennsylvania and Dr. Matthew Morrow, a post-doctorate research fellow at University of Pennsylvania.

17 Jun 2010

Proportion of substance abuse treatment admissions involving older Americans doubles: SAMHSA

A new study reveals that between 1992 and 2008 the proportion of substance abuse treatment admissions involving older Americans (aged 50 and older) nearly doubled -- from 6.6 percent of all admissions in 1992 to 12.2 percent in 2008. The study, sponsored by the Substance Abuse and Mental Health Services Administration, also shows a sharp rise during this period in the proportion of older Americans admissions related to illicit drug abuse -- even though alcohol abuse is still the leading cause for admissions involving this age group.

17 Jun 2010

Implications for reducing clotting in kidney disease dialysis and sepsis

The interaction of the drug compstatin with two ancient, co-evolved human systems points to new ways for reducing clotting during dialysis for end-stage kidney disease and multiple organ failure due to sepsis, a dangerous whole-body inflammatory response to infection.

17 Jun 2010

Patients prescribed NSAIDs also receive appropriate measures to prevent UGI problems: Study

Four out of ten high-risk patients prescribed nonsteroidal anti-inflammatory drugs also received appropriate measures to prevent upper-gastrointestinal problems, but the remainder did not receive adequate protection, according to a study in the June issue of Alimentary Pharmacology and Therapeutics.

17 Jun 2010

USFDA approves Sun Pharma's generic Keppra Injection ANDA

Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Keppra® Injection, levetiracetam injection.

17 Jun 2010

CINJ researchers combine series of vaccination injections to treat prostate cancer

Looking to harness the body's own immune system to target prostate cancer that has spread to the bones (metastatic) and is unresponsive to standard treatment, investigators at The Cancer Institute of New Jersey have just launched a clinical trial focusing on a combination of vaccine and radiation drug therapy.

17 Jun 2010

Daily use of probiotics reduces VAP in critically ill patients: New research

Daily use of probiotics reduced ventilator-associated pneumonia in critically ill patients by almost half, according to new research from Creighton University School of Medicine in Omaha, Nebraska.

17 Jun 2010

Experimental vaccine for Marburg hemorrhagic fever prevention shows promise for accidental exposures

An experimental vaccine developed to prevent outbreaks of Marburg hemorrhagic fever continues to show promise in monkeys as an emergency treatment for accidental exposures to the virus that causes the disease. There is no licensed treatment for Marburg infection, which has a high fatality rate.

17 Jun 2010

Pharmaceutical News

HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

Fraudulent Tamiflu sold over Internet, FDA warns

FDA approves new indication for Tasigna in treatment of rare blood cancer

Ricerca announces services under U.S. DEA license

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

FDA approves Jevtana to treat men with prostate cancer

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Study evaluates effect of Viusid on oxidative stress, cytokine parameters in patients with CHC

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

China Yongxin Pharmaceuticals expands chain of drugstores to 103

2009 H1N1 pandemic influenza vaccine protects against 1918 influenza virus: Report

Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

Scientific American publishes article on "rebirth" of DNA vaccines

Proportion of substance abuse treatment admissions involving older Americans doubles: SAMHSA

Implications for reducing clotting in kidney disease dialysis and sepsis

Patients prescribed NSAIDs also receive appropriate measures to prevent UGI problems: Study

USFDA approves Sun Pharma's generic Keppra Injection ANDA

CINJ researchers combine series of vaccination injections to treat prostate cancer

Daily use of probiotics reduces VAP in critically ill patients: New research

Experimental vaccine for Marburg hemorrhagic fever prevention shows promise for accidental exposures

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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