Articles Tagged with ''Daily International Pharma Alert''

CDC FINDS MERCK'S ROTAVIRUS VACCINE TO BE SAFE

The U.S. Centers for Disease Control and Prevention (CDC) has released new safety data on Merck's RotaTeq rotavirus vaccine showing that the vaccine does not pose an elevated risk for intussusception, the most common cause of bowel obstruction in infants.

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MHRA REVISES ELECTRONIC SUBMISSION GUIDELINES

To help companies move to electronic common technical document (eCTD) format, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced it will accept electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but that do not have an extensible markup language (XML) backbone.

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PFIZER WINS NIGERIAN PATENT SUIT

A Nigerian high court has ruled in favor of Pfizer in a patent infringement suit brought against two local companies, Tyonex Nigeria and Ebamic Pharmacy, for selling an unauthorized drug containing the same active ingredient as Pfizer's hypertension drug Norvasc, reports the Lagos, Nigeria-based daily newspaper Vanguard.

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FDA APPROVES NEW DRUG FOR ADVANCED BREAST CANCER

GlaxoSmithKline's (GSK) kinase inhibitor Tykerb has gained FDA approval for use in combination with Roche's oral chemotherapeutic Xeloda for the treatment of advanced metastatic breast cancer — specifically in tumors that produce an excess of the HER2 protein.

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