World Pharma News Digest - 23.11.2009

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Ruslan David

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Nov 23, 2009, 7:50:13 AM11/23/09
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Merck Receives CHMP Positive Opinion for New Fertility Treatment, ELONVAВ® 
Merck & Co., Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVAВ® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. 
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http://www.worldpharmanews.com/content/view/1031/1/
 
85% of Online Europeans Use the Internet for Health Information 
In 2009, 85% of online Europeans in the United Kingdom, Germany, France, Italy, and Spain turn to the Internet and other technologies for health and prescription drug information, according to the latest Cybercitizen HealthВ® Europe v9.0 study from healthcare and pharmaceutical market research company Manhattan Research. The collaboratively-edited Wikipedia again proves to be a top online health resource for consumers in all of the countries surveyed. 
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http://www.worldpharmanews.com/content/view/1030/1/
 
FDA Advisory Committee Finds Data Support SPIRIVAВ® HandiHalerВ® 
The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVAВ® HandiHalerВ® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD). 
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http://www.worldpharmanews.com/content/view/1029/1/
 
AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor) 
AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. 
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http://www.worldpharmanews.com/content/view/1028/1/
 
GSK and Nabi announce agreement for NicVAXВ®, a vaccine for nicotine addiction 
GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) announcedan exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAXВ®), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine. 
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http://www.worldpharmanews.com/content/view/1027/1/
 
Study Meets Primary Endpoint with 25 Percent LDL Reduction in Very High-Risk Patient Population 
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were presented at the American Heart Association's Scientific Sessions. 
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http://www.worldpharmanews.com/content/view/1026/1/
 
Lower doses of antigen may suffice to generate a protective immune response against A(H1N1) 
Novartis announced new interim data from ongoing clinical trials demonstrating that a single 7.5Вµg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (>=65 years of age). 
Read more... 
http://www.worldpharmanews.com/content/view/1025/1/
 
PharmaNews.eu / Latest News
 
EMEA makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
http://www.pharmanews.eu/emea/389-emea-makes-recommendations-to-minimise-risk-of-nephrogenic-systemic-fibrosis-with-gadolinium-containing-contrast-agents
 
Boehringer Ingelheim and GlaxoSmithKline back EFA's call for urgent improvements in care for people with lung disease
http://www.pharmanews.eu/boehringer-ingelheim/388-boehringer-ingelheim-and-glaxosmithkline-back-efas-call-for-urgent-improvements-in-care-for-people-with-lung-disease
 
 
 
 
Pfizer Submits New Pediatric Data For LipitorВ® (Atorvastatin) To The European Medicines Agency (EMEA)
http://www.pharmanews.eu/pfizer/384-pfizer-submits-new-pediatric-data-for-lipitorr-atorvastatin-to-the-european-medicines-agency-emea
 
Study Meets Primary Endpoint with 25 Percent LDL Reduction in Very High-Risk Patient Population
http://www.pharmanews.eu/genzyme/383-study-meets-primary-endpoint-with-25-percent-ldl-reduction-in-very-high-risk-patient-population
 
 
 
 
With best regards,
Ruslan David, MD
Administrator/Editor
 
 
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