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The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
The FDA has given its blessing to Wellstat Therapeutics’ Vistogard for the emergency treatment of adults and children who receive an overdose of chemotherapy treatment fluorouracil or capecitabine. Read More
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