Amid all the bills aimed at shining light into the black box of U.S. drug pricing and ending anticompetitive games, the House is planning on rolling out legislation in September that would directly impact the price of what could be hundreds of drugs by requiring Health and Human Services (HHS) to negotiate some prices. While the details of the bill have yet to be ironed out, Wendell Primus, senior policy adviser to House Speaker Nancy Pelosi (D-Calif.), said the legislation will give HHS the clear authority to negotiate drug prices, along with a mandate and instructions to do so.

The FDA finalized its guidance on postmarket safety reporting for combination products. Along with general information on combination products and a discussion of how the FDA regulates the products, the guidance explains a final rule on the safety reports that was issued in December 2016 and discusses which entities are subject to the rule. It also advises on how to comply with the requirements and gives hypothetical scenarios illustrating compliance with specific safety reporting requirements.

The U.S. Biomedical Advanced Research and Development Authority is working with the Defense Threat Reduction Agency and Venatorx Pharmaceuticals Inc. to develop VNRX-5133, which, when combined with cefepime, may overcome certain forms of antibiotic resistance. The cefepime/VNRX-5133 intravenous combination holds potential as a treatment for drug-resistant gram-negative infections that cause complicated urinary tract infections, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, as well as potential bioterrorism pathogens that cause glanders and melioidosis.