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Regulatory Affairs

EMEA recommends suspension of the marketing authorisation of Raptiva (efalizumab)

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine.

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European Medicines Agency welcomes continuation of D:A:D study

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has welcomed the commitment of the sponsors to continue the D:A:D study at least until 2012. This ensures that the study, which was started on the initiative of the EMEA in 1999, will remain one of the most powerful pharmacovigilance tools to monitor the long-term safety of antiretroviral medicines.

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FDA Approves Drug for Patients with Advanced Prostate Cancer

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer.

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FDA's Monthly Video Series Wins Award

The U.S. Food and Drug Administration"FDA Patient Safety News," the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors.

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EMEA recommends the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride)

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride), from Janssen-Cilag International NV, because of a defect with the delivery system of the medicine that could lead to patients being overdosed.

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FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic.

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FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

U.S. Food and Drug AdministrationAs part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government has seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals.

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Abbott Launches New Psoriasisanswers.com Web site

August marks National Psoriasis Awareness Month, an opportunity to raise awareness about psoriasis, a skin disease that affects nearly 7.5 million Americans. For those living with this condition, finding information Read more

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AstraZeneca Headquarters, London

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, Read more

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Site Roche Basel

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in Read more

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Gehry building, Novartis headquarters in Basel, Switzerland

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving Read more

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GSK Corporate HQ

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better Read more

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Sanofi-aventis Group head office

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: Read more

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Boehringer Ingelheim Center, Ingelheim, Germany

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 Read more

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Novo Nordisk's corporate headquarters in Bagsværd, Denmark

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth Read more

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