Good morning, readers.
I hope you had a wonderful weekend. Cliff is on his way back from the Fortune and Time Global Forum in Rome, so I'll be filling in once again (you can read complete coverage of the event here).
Over the weekend, researchers, investors, and experts from around the world congregated for the American Society of Hematology's (ASH) annual meeting. ASH 2016 has been one of the most anticipated scientific conventions of the year, with companies like Novartis, Kite, and Juno presenting critical new data about a next-gen set of drugs that are being tested in numerous blood cancers.
The companies jockeying for a first-to-market advantage in the space have encountered plenty of twists and turns along the way—and it appears that pharma giant Novartis may well achieve its original goal of a pioneering FDA approval for its own experimental treatment.
Read on for my write-up and more of the day's news.
Novartis says it's back on track to have the world's first approved CAR-T cancer drug. As regular readers know, CAR-T is one of the most closely watched experimental cancer technologies in the world right now. The novel treatment space involves transforming a patient's own immune T-cells into cancer-busting weapons. But while the technology itself is undeniably exciting, some companies, like Juno Therapeutics, have been struggling with the reality of dangerous side effects including cytokine release syndrome and brain swelling during trials. Now, it appears that pharma giant Novartis may gain the first approval for a CAR-T drug in 2017. The company announced during the American Society of Hematology (ASH) annual meeting over the weekend that it's prepared to file for FDA approval of CTL019 in early 2017 after promising phase 2 clinical trials showing that patients with the blood cancer B-cell acute lymphoblastic leukemia achieved a significant 82% complete remission rate after being injected with the drug. Novartis had always hoped to be first to the finish line in this space, but it's always been far from a certainty.
21st Century Cures would curb FDA regulation of health apps. Among the grab bag of goodies in the pharma-backed 21st Century Cures Act, which is meant to hasten FDA drug approvals, is a provision that would essentially remove the agency from the mobile health app and electronic medical records regulatory process. The House-passed version of the bill says that the FDA cannot regulate apps meant for "maintaining and encouraging a healthy lifestyle" and electronic health records that are equivalent to a paper medical history. However, the agency could theoretically step in to regulate health IT if there is significant evidence that a particular system could lead to possible serious adverse health events. (Modern Healthcare)
This VR headset allows moms to experience what their babies are going through. In a novel advancement of radiological technology, Brazilian researchers have created a product that takes fetal MRI and ultrasound data and transform them into a three-dimensional representation of what a fetus is experiencing. This can then be fed into a virtual reality headset to be used by prospective parents. "The 3-D fetal models combined with virtual reality immersive technologies may improve our understanding of fetal anatomical characteristics and can be used for educational purposes and as a method for parents to visualize their unborn baby," said study co-author Dr. Heron Werner Jr.
Lilly gets a big win as diabetes med approved to reduce risk of heart attack, stroke. Eli Lilly took a body blow with the high profile failure of its experimental Alzheimer's treatment last month (including the prospect of looming job cuts). But the U.S. pharma giant and its German partner Boehringer Ingelheim won a big victory on Friday as the Food ad Drug Administration (FDA) approved their diabetes drug Jardiance as a treatment to reduce the risk of heart attack, stroke, and other cardiovascular events in type 2 diabetes patients. Jardiance is now the first ever oral diabetes drug approved for such an indication, and the approval could make it a go-to option for diabetes patients with cardiovascular disease. That's particularly significant since people with diabetes have a significantly higher risk of developing cardiovascular conditions—and Lilly's drug was shown to cut the cardiovascular-related deaths in diabetes patients by a staggering 38% in clinical trials.
Cerecor slammed as lead nicotine withdrawal drug flunks clinical trial. Biotech Cerecor nearly plunged into penny stock territory on Monday after the firm reported that its experimental drug to treat nicotine withdrawal had flunked a phase 2 clinical trial. That's particularly unfortuante for Cerecor seeing as CERC-501 is the company's lead drug candidate—and the news comes just days after Cerecor announced that a separate experimental depression drug called CERC-301 had also failed in the clinic. (Endpoints)
THE BIG PICTURE
Medical spending hit $3.2 trillion in 2015. A new report from the Centers for Medicare and Medicaid Services (CMS) finds that U.S. healthcare spending soared to $3.2 trillion in 2015—a 5.8% jump. And, for the first time ever, the federal government made up the biggest share of spending (29%) thanks to Obamacare's expansion of Medicaid. The news is discouraging because it presents the second consecutive year of 5%-plus healthcare spending inflation after a period of time when spending growth appeared to be hitting historic lows. And CMS believes that spending will only continue to rise as the population gets older and the price of hospital services and prescription drugs remains high.
Michael Bloomberg wants to make the world quit smoking. Former New York Mayor Michael Bloomberg made history by passing an indoor smoking ban for bars and restaurants in the city which has been credited with slashing hospitalization and heart attack rates. Now, he wants to get as many people as possible around the world to kick the habit, pouring $300 million over the next five years to boost anti-smoking measures across the globe. "Reducing tobacco use is one of our greatest opportunities to save lives and prevent suffering, because we know that strong policies really do make a difference," Bloomberg said in a statement. "Since we began working ten years ago to pass effective tobacco measures around the world, global sales of cigarettes have declined after a century of steadily increasing." (Fortune)
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