The House of Representatives on July 10 approved the 21st Century Cures Act by a vote of 344 to 77, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More

The FDA has given Blueprint Medicines the go-ahead to begin Phase I clinical trials for its investigational BLU-285 and BLU-554 to treat gastrointestinal tract, liver and biliary duct cancers. Read More

Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More

The European Medicines Agency released final guidance June 10 on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More

The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said Thursday at the DIA annual meeting. Read More

Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More

Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More

The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More

Because cellular and gene therapy products can have more severe effects than other types of drug products, potentially leading to organ failure, tumors or death, sponsors should include these as primary safety objectives when designing early-phase clinical trials, the FDA says. Read More

The FDA is making good on promises to consider patient preferences in device approvals, draft guidance issued May 14 makes clear. Read More

New guidance on extrapolating existing data to gain approval for pediatric indications applies to new devices as well as those already approved for adult use, an FDA official says. Read More