The House of Representatives passed the 21st Century Cures Act in a 344-77 vote Friday morning. If passed by the Senate, the legislation would bolster National Institutes of Health funding by $8.75 billion and lower the regulatory standards for some new investigational medicines. The bill would also incentivize the use of newer drugs through changes to Medicare’s payment system.
Novartis’s recently approved drug Entresto will likely include a number of “beyond the pill” services to support the heart-failure treatment, according to The Wall Street Journal. The Swiss drugmaker hopes to win over cost-conscious payers and insurers with an array of tools, like a remote monitoring device that would show early signs of deterioration in heart-failure patients. “We’re going to have to get smarter about services around the pill … and move into some areas that are different from just discovery of the drug,” Novartis CEO Joe Jimenez told the Journal. “You’re going to see Novartis go to payers with multiple services.”
Purdue Pharma and GlaxoSmithKline could be the first two drugmakers to use Apple’s ResearchKit. A GSK project manager told BuzzFeed that it plans on integrating clinical trials into the software framework in the coming months and Purdue Pharma said it was also exploring the use of ResearchKit as an R&D tool. GSK sees the ResearchKit as a way to “improve patient engagement and data collection.”
The FDA issued an untitled letter to Ascend Therapeutics for its EstroGel co-pay card, saying the card omitted serious risks associated with the menopause treatment. A review officer from the agency’s Office of Prescription Drug Promotion charged the drugmaker with selectively excluding certain risk information, writing that it did not disclose information about risks including cancer and cardiovascular disorders. “By omitting serious risks associated with EstroGel, the Zazzle card misleadingly suggests that EstroGel is safer than has been demonstrated,” the letter said.
GlaxoSmithKline’s chief strategy officer said in an interview that there are “diminishing returns in HIV” due to how effective treatments have become in containing the virus, according to Bloomberg Business. “The industry has done a fantastic job of taking the fear of the late ’80s, and the death sentence, and taking that to one tablet a day,” Redfern said. GSK’s HIV treatment Tivicay had sales of $467 million last year.