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The FDA has granted approval to Genentech’s Alecensa for metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer in patients whose disease has worsened after taking Pfizer’s Xalkori, or who could not tolerate the treatment. Read More
Type 2 diabetes drugs have elevated reporting rates for pancreatitis, hypoglycemia and diabetic ketoacidosis, which adds to suspicions of class-wide side effect issues, especially for DPP-4 drugs, a new analysis from Advera Health Analytics said. Read More
Janssen is petitioning the U.S. Supreme Court to overturn a $124 million verdict that it made false claims about antipsychotic drug Risperdal (risperidone) and hid risk information from physicians. Read More
As Merck looks to expand the indications of its lipid-reducing drug Vytorin to include cardiovascular outcomes, the FDA is asking whether trial findings describe the full picture well enough to substantiate benefit. Read More
Horizon Pharma has acquired Lake Forest, Ill.-based Crealta Holdings for $510 million in cash, in a deal that expands Horizon’s orphan drug business, the Irish firm said Friday. Read More
The treatment is for patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma and transformed follicular lymphoma. Read More
The FDA issued a warning that active pharmaceutical ingredient baclofen manufactured by Taizhou Xinyou Pharmaceutical & Co. Limited, may be at risk for contamination and should not be used to compound sterile injectable drugs. Read More
Indian analysts attribute ongoing quality control issues with pharmaceutical exports to a dearth of pharmaceutical inspectors and a lack of uniform standards in the country. Read More