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European Health Regulators to Review AstraZeneca’s Investigational Gout Drug

The European Medicines Agency (EMA) has accepted AstraZeneca’s marketing authorization application for its investigational gout drug, which the company acquired through its acquisition of Ardea Biosciences. AstraZeneca said that the EMA accepted its application for lesinurad 200mg tablets for the chronic treatment of hyperuricaemia in gout patients. Lesinurad is a …

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Hormonal Contraceptives Linked to an Increased Risk of Rare Brain Cancer

Long-term use of contraceptive pills may double the risk of developing brain cancer, according to a new study. Scientists say that taking hormonal contraception, particularly progesterone-only methods, for five years more than doubles the chance of developing glioma, a rare type of brain cancer which affects roughly five in 100,000 …

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AbbVie’s Hepatitis C Drug Wins EC Approval

European regulators have approved AbbVie’s all-oral, interferon-free hepatitis C drug. The company announced today that the European Commission (EC) has granted marketing authorizations for Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) for treatment with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 …

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Study Finds Although Fewer Colorectal Patients Having Surgery, Survival Rates are Improving

While patients with metastatic colorectal cancer are undergoing less surgery for the removal of their primary tumors, survival rates for the disease are improving, according to a new study. According to The University of Texas MD Anderson Cancer Center, with new chemotherapeutic and biologic agents available for managing metastatic colorectal …

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ASCO Submits Comments to Congress on FDA’s Proposed Regulation of Laboratory-Developed Tests

ASCO submitted comments Jan. 5 to the House Committee on Energy and Commerce, Health Subcommittee, strongly supporting the Food and Drug Administration’s proposed risk-based approach to regulation of laboratory developed tests (LDTs). LDTs are increasingly being used to guide therapy selection for patients with cancer. Failure of such tests to …

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