politics
Trump administration to crack down on pharma ads
President Trump yesterday directed health secretary Robert F. Kennedy Jr. to crack down on misleading direct-to-consumer drug advertisements. At the same time, the FDA said it would begin rule-making to close a regulatory loophole that allows drug companies to direct patients to an external source instead of listing a drug’s full safety profile in the ad.
The FDA also said it was sending thousands of warning letters to drug companies currently running “deceptive” ads, but did not disclose the names of the companies.
The agency's announcement offered few details on how it would enforce more transparent drug advertising going forward.
Read more from STAT's Lizzy Lawrence.
politics
RFK Jr. looks to add new members to vaccine advisory panel
Health officials are planning to add more people handpicked by health secretary Robert F. Kennedy Jr. to the CDC's vaccine advisory panel, a former government official confirmed to STAT.
The apparent new candidates include an infectious disease expert who opposed Covid-19 mandates, a physician who has called for mRNA shots to be pulled off the market, and a pharmacist who has focused on low-income medication distribution.
Kennedy fired all former members of the Advisory Committee on Immunization Practices in June and selected new members, including several vaccine skeptics. The group is slated to meet next week and discuss shots for Covid-19, RSV, hepatitis B, and MMRV.
Read more.
financing
Odyssey raises $213 million for autoimmune drugs
Odyssey Therapeutics raised a $213 million Series D round to fund its development of autoimmune drug candidates, the biotech said this morning.
All existing investors participated, as well as new firms including Affinity Asset Advisors, Dimension Capital, Lightspeed Ventures, and more.
Despite the prolonged downturn in the biotech industry, venture capitalists have still plowed money into startups making autoimmune drugs. The mega round is also an example of a recent trend in biotech investing — that firms are being more selective and putting more money into fewer companies.
Odyssey's lead candidate is a small molecule RIPK2 scaffolding inhibitor designed to treat ulcerative colitis and Crohn's disease.
PHARMA
Lawmakers urge HHS to abandon 340B rebate initiative
More than 160 U.S. lawmakers have urged the Trump administration to abandon a newly announced pilot program around the 340B federal drug discount program.
The program was created to help hospitals care for low-income and rural patients. Traditionally, drugmakers would offer discounts to these hospitals upfront, but the pilot program allows pharma companies to instead offer rebates after a medication is expensed.
Pharma companies have argued for the rebate model to avoid double discounts. But hospitals argue it would put them under enormous financial strain.
Read more from STAT's Ed Silverman.
health tech
Apple's watch update may increase demand for hypertension drugs
Apple unveiled a new feature of its smartwatch yesterday that notifies users they may have high blood pressure.
The tech giant didn't detail the feature in depth, but said that an algorithm works in the background and the watch alerts people if it detects patterns of high blood pressure over a 30-day period.
Apple has repeatedly added heart health features to its smartwatch, but critics note that screening a large population for disease will potentially flag many people who do not have conditions, causing anxiety and increasing health care costs.
Over time, this feature could lead more patients to seek out hypertension treatments. Apple said it expects to notify over 1 million people in just the first year.
Read more from STAT's Mario Aguilar.