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FDA advisory committee votes against Avodart sNDA for prostate cancer risk reduction

GlaxoSmithKline today announced the results of a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

2 Dec 2010

International trial confirms long-term benefits of anastrozole to stop breast cancer

A major international trial has confirmed the long-term benefit of anastrozole to help stop breast cancer coming back or developing in the other breast in postmenopausal women with hormone sensitive early breast cancer, according to a study published in Lancet Oncology today (Wednesday).

2 Dec 2010

GSK and Valeant receive FDA Complete Response letter for ezogabine

GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced receipt of a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.

2 Dec 2010

FDA approves CUBICIN 2-minute IV injection for MRSA skin infections, bacteremia

Cubist Pharmaceuticals, Inc. today announced that its currently-marketed antibiotic, CUBICIN (daptomycin for injection), has been approved by the U.S. Food & Drug Administration (FDA) for once-a-day dosing as a 2-minute intravenous (IV) injection.

2 Dec 2010

Bill & Melinda Gates Foundation awards $6M grant to NanoBio to develop intranasal vaccine for RSV

NanoBio Corporation announced today that it has received a $6M grant from the Bill & Melinda Gates Foundation to support the development of a safe and effective intranasal vaccine for Respiratory Syncytial Virus (RSV).

1 Dec 2010

High levels of variability, inconsistencies found in children's medication labeling and measuring devices

An examination of 200 of the top-selling cough/cold, allergy, analgesic and gastrointestinal over-the-counter liquid medications for children finds that there have been high levels of variability and inconsistencies regarding medication labeling and measuring devices, according to a study that will appear in the December 15 issue of JAMA. The study is being released early online because of its public health importance.

1 Dec 2010

Research reveals tricyclic anti-depressants increase risk of CVD

Research that followed nearly 15,000 people in Scotland has shown that a class of older generation anti-depressant is linked to an increased risk of cardiovascular disease (CVD). The study showed that tricyclic anti-depressants were associated with a 35% increased risk of CVD, but that there was no increased risk with the newer anti-depressants such as the selective serotonin reuptake inhibitors (SSRIs).

1 Dec 2010

Research shows anti-microbial medications lead to acute liver failure

New research shows that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure (ALF), with women and minorities disproportionately affected.

1 Dec 2010

Elorac's naloxone lotion receives FDA Orphan Drug Designation for pruritus associated with mycosis fungoides

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for its naloxone lotion for the topical treatment of pruritus accompanying cutaneous t-cell lymphoma (CTCL, also known as mycosis fungoides).

1 Dec 2010

Opinions: Obama's Global Fund pledge; harm reduction in Iran; HIV prevention; African development

There are some encouraging signs in the epic battle against AIDS and HIV infections. But those bright spots dim considerably in the face of the fact that about 7,100 people a day become infected.

30 Nov 2010

Jiangsu Yanshen found liable for producing and selling inferior quality products

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded and proprietary pharmaceuticals in China, today announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd. ("Jiangsu Yanshen"), in which Simcere holds a 52.5% controlling stake, has been found liable for producing and selling inferior quality products by the People's Court of Tianning District, Changzhou City and was sentenced to a fine of RMB4.6 million.

30 Nov 2010

Resverlogix files new patent for dosing combinations of RVX-208, statin therapeutics

Resverlogix Corp. is pleased to announce today that it has filed additional new patent protection based on novel findings derived from its recently completed ASSERT Phase 2 clinical trial.

30 Nov 2010

DTRA presents Outstanding Scientific Achievement award to Aduro BioTech

Aduro BioTech, a clinical-stage immunotherapy company, is pleased to announce the "Outstanding Scientific Achievement" award from the Defense Threat Reduction Agency. The award was presented at the 2010 Chemical and Biological Defense Science and Technology Conference in Orlando, Florida to Dr. Justin Skoble, Associate Director, Biodefense and Process Development at Aduro BioTech.

30 Nov 2010

Dongsheng enters agreement to acquire micro-emulsion alprostadil injection from Wan'Te

Dongsheng Pharmaceutical International Co., Ltd. announced today that it has entered into an agreement with Shanghai Wan'Te Pharmaceutical Co., Ltd. to acquire the intellectual property, exclusive sales and manufacturing rights of micro-emulsion alprostadil injection from Wan'Te for total proceeds of RMB10 million, of which RMB5 million will be paid in cash and RMB5 million will be paid in shares of the Company's common stock.

30 Nov 2010

APP to launch Topotecan for Injection following FDA marketing approval

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

30 Nov 2010

University of Adelaide researcher leads collaboration for universal flu vaccine

A University of Adelaide researcher is leading a collaboration between Australia and Indonesia on the production of a universal flu vaccine. The frequent arising of new influenza strains represents the greatest challenge to health authorities as it renders currently available vaccines ineffective, says Dr Mohammed Alsharifi, the Head of the Vaccine Research Group at the School of Molecular and Biomedical Science, University of Adelaide.

30 Nov 2010

Case Western Reserve University grants Thermalin Diabetes exclusive license on portfolio of insulin analogs

Case Western Reserve University has granted an exclusive license on a portfolio of insulin analogs to Thermalin Diabetes, LLC, which has assembled more than $3 million to support the development of these important new drugs.

30 Nov 2010

Alza files patent infringement suit against Impax in connection with Concerta

Impax Laboratories, Inc. today confirms that Alza Corporation has filed suit for patent infringement against Impax in the United States District Court for the District of Delaware in connection with Concerta® (methylphenidate hydrochloride) extended-release 54 mg tablets.

30 Nov 2010

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

Acrux , a drug delivery company that develops and commercializes patented pharmaceutical products for global markets, and Eli Lilly Company today announced that the United States Food and Drug Administration (FDA) has approved the Axiron® topical solution CIII for testosterone replacement therapy in men. Axiron is the first testosterone topical solution approved for application via an underarm applicator.

29 Nov 2010

WomanCare Global expands product portfolio to include Roselle, Optinor

WomanCare Global is pleased to announce an expansion of their global product portfolio to include Roselle, a combined oral contraceptive (COC) pill containing 150 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol and Optinor, a progesterone-only emergency contraception pill (ECP) containing 750 micrograms of levonorgestrel.

29 Nov 2010

Pharmaceutical News

FDA advisory committee votes against Avodart sNDA for prostate cancer risk reduction

International trial confirms long-term benefits of anastrozole to stop breast cancer

GSK and Valeant receive FDA Complete Response letter for ezogabine

FDA approves CUBICIN 2-minute IV injection for MRSA skin infections, bacteremia

Bill & Melinda Gates Foundation awards $6M grant to NanoBio to develop intranasal vaccine for RSV

High levels of variability, inconsistencies found in children's medication labeling and measuring devices

Research reveals tricyclic anti-depressants increase risk of CVD

Research shows anti-microbial medications lead to acute liver failure

Elorac's naloxone lotion receives FDA Orphan Drug Designation for pruritus associated with mycosis fungoides

Opinions: Obama's Global Fund pledge; harm reduction in Iran; HIV prevention; African development

Jiangsu Yanshen found liable for producing and selling inferior quality products

Resverlogix files new patent for dosing combinations of RVX-208, statin therapeutics

DTRA presents Outstanding Scientific Achievement award to Aduro BioTech

Dongsheng enters agreement to acquire micro-emulsion alprostadil injection from Wan'Te

APP to launch Topotecan for Injection following FDA marketing approval

University of Adelaide researcher leads collaboration for universal flu vaccine

Case Western Reserve University grants Thermalin Diabetes exclusive license on portfolio of insulin analogs

Alza files patent infringement suit against Impax in connection with Concerta

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

WomanCare Global expands product portfolio to include Roselle, Optinor

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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