A judge tossed a lawsuit brought by pharmaceutical companies to block a California law requiring advance notice of big price increases; the FDA is testing all angiotensin II receptor blockers (ARBs) over a discovered impurity that is linked to cancer; research in monkeys has suggested that an experimental painkiller is effective at easing pain without being addictive.
A lawsuit brought by pharmaceutical companies to block a California law that requires notice before big drug price increases has been dismissed by a judge, according to the Associated Press. The law requires pharmaceutical companies to provide 60 days’ notice before raising the national wholesale price above a certain threshold. Pharmaceutical Research and Manufacturers of America has 30 days to refile after the judge determined it failed to show that the court had jurisdiction to hear the case.
The FDA is testing angiotensin II receptor blockers (ARBs) over a substance linked to cancer. According to STAT, the impurity in the drugs, known as NDMA, is an organic chemical and a possible carcinogen. The FDA believes the impurity occurred during the manufacturing process and is testing all products in the ARB class. In a worst-case scenario, the agency estimated that if 8000 people took the highest-dose pill with NDMA daily for 4 years, there would be 1 additional case of cancer beyond the average cancer rate. Most patients received less exposure than this worst-case scenario.
Research in monkeys has suggested that an experimental painkiller is effective while also being less addictive than opioids. HealthDay reported that the AT-121 provides the same pain relief as an opioid but at a much lower dose. The compound blocked abuse potential, similar to how buprenorphine does for heroin. In addition, the monkeys did not exhibit withdrawal symptoms after they stopped using AT-121 after 3 days. The success in monkeys suggests that the findings could be replicated in humans, but it is not guaranteed.