Good morning, Dailies. I’m in Aspen for FORTUNE Brainstorm Tech, which kicks off today at 2pm mountain time and continues through Wednesday. We’re live-streaming all of the main-stage events and you can find a complete schedule of sessions right here:
Among today’s highlights, check out the following conversations (all times MT):
3:00 PM Michael Dell, CEO, Dell Technologies; Egon Durban, managing partner and managing director, Silver Lake.
4:05 PM Glenn Fogel, CEO, Priceline Group
4:30 PM Steve Mollenkopf, CEO, Qualcomm
6:45 PM Gen. Stanley McChrystal (Ret.), founder, McChrystal Group
Tomorrow, I’ll be moderating what I hope and expect will be a thoroughly engaging roundtable discussion with four disruptive health pioneers: Adrian Aoun, the founder and CEO of Forward; Daniel Chao, cofounder and CEO of Halo Neuroscience; Arun Gupta, founder and CEO of Quartet Health; and Lisa Maki, cofounder of PokitDok.
I’ll tell you what I learn. In the meantime, dive into our live-stream of the conference here and read the coverage reports from our crack squad of reporters, which we’ll post as the meeting goes on.
More news below.
The year of the gene-based treatments continues with FDA priority review for Spark Therapeutics. Shares of biotech Spark Therapeutics rose 4.5% in early Monday trading after the Food and Drug Administration (FDA) agreed to review its gene therapy for vision loss patients who have vision loss due to a rare genetic condition called biallelic RPE65-mediated inherited retinal disease (IRD). Not only did the FDA accept Spark's application—it granted it a "priority review" status which shaves four months off of its regulatory review period for the drug. That means the treatment could be approved on or before January 12, 2018, which would make it the first-ever gene therapy cleared to treat a genetic condition in the U.S. Other landmark genetic-altering treatments have also gained traction in recent weeks, including Novartis' cancer therapy which morphs human immune cells into personalized cancer-killers.
Corporate drama swirls around AstraZeneca CEO rumors. Early rumors that British pharma giant AstraZeneca's chief executive, Pascal Soriot, was considering jumping ship to the major (and troubled) generic drug manufacturer Teva sent the biopharma world into a tizzy. But the early reports may have been, well, a bit too early. In a signal that Soriot may not be going anywhere anytime soon, AstraZeneca announced that he would be hosting the company's earnings call at the end of the month. AZ shares rebounded on Monday after falling significantly at the end of last week.
FDA rejects Amgen's osteoporosis drug. The FDA has declined to approve biotech Amgen's experimental romosozumab, a treatment for osteoporosis. This was an expected rejection for the company based on safety data; regulators were concerned about an increased risk of cardiovascular side effects. But Amgen and partner UCB plan to press forward with new data submissions to show that the treatment is safe.
THE BIG PICTURE
Obamacare repeal reaches its next stage of uncertainty with McCain surgery. Senate Majority Leader Mitch McConnell has yet again delayed a vote on the Senate's controversial health care bill—this time, because Arizona Sen. John McCain is recovering from surgery (and without him, there aren't enough votes to pass the legislation). It's also an open question if the current iteration of the Better Care Reconciliation Act (BCRA) could pass even if McCain were available to vote. An amendment from Texas Sen. Ted Cruz was roundly criticized by insurance companies over the weekend, who warned that it would create an unsustainable market. Stay tuned.
That artificial sweetener may not be helping you lose weight. A large new review of the available suggests there isn't very strong evidence that consuming artificial sweeteners (rather than sugar) is associated with weight loss. "There is no clear benefit for weight loss, and there's a potential association with increased weight gain, diabetes and other negative cardiovascular outcomes," lead study author Meghan Azad tells NPR. On that latter possibility, however, it's important to note that the study didn't specifically link artificial sweeteners with worse health effects. The authors say that more research would need to be done to determine exactly what the long-term consequences of these sweeteners are. (NPR)
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