Since 1998, the US FDA has approved 3 drugs for brain cancer, 10 for lung cancer and 7 for melanoma. However, for brain cancer, 75 drugs failed in development, 167 therapies for lung cancer failed in clinical trials, and 96 drugs for melanoma failed in development. Presently, in the US, 47 new therapies for brain […]

A summary of biopharmaceutical approvals in the US and UK from January 2010 to July 2014 showed that 54 products were approved. Drugs new to the market accounted for 59% of the therapies (32), with the remaining biologics being biosimilars, reformulated and me-too drugs, and products that previously had been approved elsewhere. Of the 32 […]

The FDA has announced revisions to four areas of its proposed rules for implementation of the Food Safety Modernization Act. For the rule on produce safety, the proposed revision includes water-quality–testing requirements for produce safety, including an updated microbial-quality standard, greater flexibility for compliance with the microbial standard, and a more targeted approach to testing […]

The first US application for a biosimilar, a generic version of Amgen’s Neupogen, was submitted to the FDA in July by Novartis. So far, the FDA has had 59 meetings with companies to discuss 14 biosimilars. Biosimilars are expected to provide a 30% discount to the price of biologics. Source: BusinessWeek

In their July survey of 958 chemical companies, ICIS and Genomatica found that over the last year, chemical producers have experienced the same level (44%) or greater (36%) interest in sustainable chemicals from their customers. More sustainable versions of chemicals are already offered by 31% of producers, with 41% expecting to offer them within the […]