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GlaxoSmithKline has withdrawn a marketing application for a cancer drug combination in Europe, saying it will wait for results from two ongoing Phase III trials before resubmitting the application. Read More
Global drug giant Pfizer said Tuesday that its Phase III Profile 1014 postmarketing commitment study of anaplastic lymphoma kinase-inhibitor Xalkori met its primary objective of prolonging progression-free survival in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) compared with platinum-based chemotherapy. Read More
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
Japanese regulators have approved Otsuka Pharmaceutical’s Samsca to treat autosomal dominant polycystic kidney disease, or ADPKD — an expanded indication that the FDA rejected last year. Read More
House Democrats are asking Gilead Sciences to justify the cost of its pricy hepatitis C pill Sovaldi, saying many of their constituents affected by the disease may not be able to afford it. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is proposing three rules changes to reduce the amount of information included in physician advertising. Read More