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MONITORING FORCE files for Flibanserin orphan drug status designation with the EMEA

MONITORING FORCE GmbH announced that they have filed on November 16th, 2009 Flibanserin in the indication treatment-relevant levodopa-induced dyskinesia in Parkinson's disease for orphan drug status designation with the European Medicines Agency (EMEA). Levodopa-induced dyskinesia is a complication of the mainstay treatment in advanced Parkinson's and a serious burden to some of those affected, since it may be disabling for the patients and preventing them from receiving optimal treatment for Parkinson's.

19 Nov 2009

VisEn Medical launches two new agents for imaging quantification

VisEn Medical Inc., a leader in fluorescence in vivo imaging from research through medicine, announced today the commercial launch of its new OsteoSense® 800 imaging agent for targeting areas of bone turnover and microcalcification in vivo. The new 800 nm OsteoSense agent complements VisEn's OsteoSense 680 and 750 products, and is expected to further expand the utilization of this agent family in enabling in vivo detection, measurement and monitoring of skeletal changes in a wide range of disease states, including arthritis, osteoporosis, and cancer metastasis.

19 Nov 2009

ScinoPharm Taiwan receives the SafeBridge Potent Compound Safety Certification

SAFEBRIDGE® CONSULTANTS, INC., headquartered in Mountain View, California, has announced that ScinoPharm Taiwan Limited in Tainan, Taiwan has met the criteria established under the SafeBridge program for “Potent Compound Safety Certification” and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (“APIs”).

19 Nov 2009

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

19 Nov 2009

Updated clinical guidelines on Effient treatment for ACS patients

Effient® (prasugrel) tablets, a new antiplatelet medicine, was added as a treatment option in two clinical guideline updates: one for patients receiving percutaneous coronary intervention (PCI) and a second one for patients with ST elevation myocardial infarction (STEMI), or severe heart attack.

19 Nov 2009

NPSF supports obligatory flu vaccination for healthcare workers

The National Patient Safety Foundation recognizes vaccine-preventable diseases as a matter of patient safety and supports mandatory influenza vaccination of health care workers to protect the health of patients, health care workers, and the community.

19 Nov 2009

Findings suggest athletes abuse non-approved therapeutic compounds for performance enhancing effects

Researchers from the German Sport University Cologne in Germany found that non-steroidal and tissue-selective anabolic agents such as Selective Androgen Receptor Modulators (SARMs) are being sold on the black market for their performance enhancing qualities.

19 Nov 2009

USP releases new CRMs for carbamazepine, phenytoin, and theophylline

To help bring greater certainty to the measurement of medication levels in a patient's bloodstream for three drugs with narrow therapeutic ranges, the U.S. Pharmacopeial Convention (USP) is releasing new certified reference materials (CRMs).

19 Nov 2009

Study: EP4 agonist may reduce gastric bleeding and inflammation

Over 300 million patients use non-steroidal anti-inflammatory drugs (NSAIDs) in the world to treat pain, arthritis, fever and other diseases. Nearly 30% of the users suffer from gastric lesions and bleeding.

19 Nov 2009

FDA Advisory Committee votes in support of Pfizer's Prevnar 13

Pfizer Inc announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children.

19 Nov 2009

FDA: Plavix-Prilosec combination may reduce anti-clotting effect

Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17.

19 Nov 2009

Data from Phase 1 safety study of SB-728-T announced

Sangamo BioSciences, Inc. announced today that data from the University of Pennsylvania investigator sponsored Phase 1 safety study of Sangamo's zinc finger nuclease (ZFN) based product, SB-728-T, for HIV/AIDS were inadvertently and prematurely disclosed on the internet.

19 Nov 2009

FDA issues complete response for Rituxan, a drug for treating chronic lymphocytic leukemia

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies’ applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL).

19 Nov 2009

New radical approach to test chemo drugs for potential toxic effects

Jackson Laboratory Professor Gary Churchill wants to change that. With a new two-year, $1 million grant from the National Cancer Institute, Churchill is launching a radical new approach to testing three chemotherapeutic drugs for potential toxic effects.

19 Nov 2009

Halifax researcher wins Prix Galien Research Award

Dr. Donald Weaver, a Halifax researcher with unmatched credentials, received the Prix Galien Research Award at a ceremony in Ottawa last night. Known as the Nobel Prize of pharmaceutical research, this award is the highest distinction worldwide for biopharmaceutical work, and the most prestigious in the field of Canadian pharmaceutical research and innovation.

19 Nov 2009

Pfizer and DNDi to battle against HAT, VL and Chagas disease

Pfizer Inc and Drugs for Neglected Diseases initiative (DNDi) have signed an agreement that is designed to facilitate advancements in the battle against human African trypanosomiasis (HAT), visceral leishmaniasis (VL) and Chagas disease, which afflict vulnerable populations in the developing world.

19 Nov 2009

Xeomin receives approval for post-stroke spasticity of upper limb in European countries

Today, Merz Pharmaceuticals announced Xeomin®, the first botulinum toxin type A free from complexing proteins has been granted an extension of indication for post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries.

19 Nov 2009

Opiate-based painkillers can increase tumor-cell proliferation, says new study

Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells.

19 Nov 2009

Sildenafil drug improves cardiac performance in young adults with congenital heart disease

Heart function significantly improved in children and young adults with single-ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia.

19 Nov 2009

People with egg allergy can have H1N1 flu vaccine in graded doses

As flu season got underway this fall, Dr. Catherine Monteleone, an allergist, noticed that her office started to receive an unusually high number of calls from people with egg allergy. They previously had avoided flu vaccines because of their sensitivity to eggs. This year, with all the attention being paid to the novel H1N1 influenza, those patients want to be protected against flu, and they contacted her to find out if they are candidates for inoculation.

19 Nov 2009