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Denmark grants marketing authorization for SUMAVEL DosePro Needle-Free Delivery System

Zogenix, Inc. and Desitin Pharmaceuticals GmbH today announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL® DosePro™ (sumatriptan injection) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL DosePro for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.

2 Dec 2010

Research: Environmental bacteria compromises effectiveness of BCG vaccine

A new discovery may explain why a tuberculosis vaccine is not as effective for some people as anticipated, and potentially explains why other vaccines do not work as well for some as they do for others.

2 Dec 2010

European Commission approves Pfizer's SUTENT for pancreatic neuroendocrine tumors

Pfizer Inc. announced today that the European Commission has approved SUTENT (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults.

2 Dec 2010

JAMA: OTC medications' dosing instructions for children adhere poorly to FDA guidelines

A recent Journal of the American Medical Association study indicates dosing instructions and dose delivery devices of over-the-counter medications for children poorly adhere to FDA guidelines.

2 Dec 2010

Study finds inconsistency in OTC medications for children

Instructions on boxes and bottles of over-the-counter (OTC) medicines for children in the United States are confusing and hard for parents to understand and follow, according to a study in the December 1 issue of JAMA.

2 Dec 2010

Patients with chronic constipation prefer Kristalose oral solution

Cumberland Pharmaceuticals Inc. today announced the publication of a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to liquid lactulose products.

2 Dec 2010

Aspirin decreases plaque formations that cause heart attacks and strokes

Charles H. Hennekens, M.D., DrPH, the first Sir Richard Doll Research Professor in the Charles E. Schmidt College of Medicine at Florida Atlantic University, has published the results of A Randomized Trial of Aspirin at Clinically Relevant Doses and Nitric Oxide Formation in Humans in the current issue of the Journal of Cardiovascular Pharmacology and Therapeutics.

2 Dec 2010

CSC files IND application to commence Phase I study for Spinal Muscular Atrophy

California Stem Cell, Inc. (CSC) and Families of Spinal Muscular Atrophy (FSMA) announced today that CSC has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for approval to commence a Phase I safety study on a jointly-developed stem cell-derived motor neuron transplantation therapy for Spinal Muscular Atrophy (SMA) Type I.

2 Dec 2010

Baxter licenses Vero cell-based influenza vaccine technology to Takeda

Baxter International Inc. and Takeda Pharmaceutical Company Limited today announced that the parties have completed a Development, License and Technology Transfer Agreement. Under the terms of the agreement, Takeda and Baxter will expand upon their previously announced collaboration to bring Vero cell culture-based influenza vaccines to the Japanese market.

From Baxter International Inc. 2 Dec 2010

DOD awards $2.24 million grant to study keratin gel in peripheral nerve regeneration

Orthopaedic researchers at Wake Forest University Baptist Medical Center (WFUBMC) have been awarded a $2.24 million four-year grant from the U. S. Department of Defense (DOD) to study the use of keratin gel in the regeneration of damaged peripheral nerves, those in the hands, arms and feet.

2 Dec 2010

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

Pharmaceutical News

Denmark grants marketing authorization for SUMAVEL DosePro Needle-Free Delivery System

Research: Environmental bacteria compromises effectiveness of BCG vaccine

European Commission approves Pfizer's SUTENT for pancreatic neuroendocrine tumors

JAMA: OTC medications' dosing instructions for children adhere poorly to FDA guidelines

Study finds inconsistency in OTC medications for children

Patients with chronic constipation prefer Kristalose oral solution

Aspirin decreases plaque formations that cause heart attacks and strokes

CSC files IND application to commence Phase I study for Spinal Muscular Atrophy

Baxter licenses Vero cell-based influenza vaccine technology to Takeda

DOD awards $2.24 million grant to study keratin gel in peripheral nerve regeneration

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

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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