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Sponsors looking to determine whether their drugs have impurities that might lead to cancer-causing mutations in human DNA should conduct two toxicology assessments using mathematical models that base this probability on the drug’s chemical structure. Read More
Germany’s healthcare cost watchdog has recommended against paying for Celgene’s Otezla, citing a lack of evidence that the psoriasis drug offers added benefit over available therapies. Read More
The FDA has granted Cerulean Pharma’s investigational nanoparticle drug conjugate CRLX101 orphan status for the treatment of relapsed ovarian cancer, guaranteeing the drugmaker seven years added exclusivity if the product is approved. Read More
Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports. Read More
German drugmaker Boehringer Ingelheim has won FDA approval for Stiolto Respimat, the fourth inhaled drug that the FDA has allowed the company to market for chronic obstructive pulmonary disease. Read More
California-based Amgen may soon be the first to get a new class of cholesterol-lowering biologics onto the European market, following a positive opinion from the European Medicines Agency on Friday. Read More
Janssen Pharmaceuticals plans to make its long-acting atypical schizophrenia therapy Invega Trinza commercially available by mid-June, following FDA approval Monday. Read More