I have written a fair amount about the war on cancer over the years—much of it skeptical of the progress we’ve made and critical of the way we’ve prosecuted this 45-year-old campaign. I have slammed the lack of collaboration and data sharing among researchers; chided our ancient, sclerotic, and deadly slow process for testing new treatments; and blasted our aversion to risk-taking and exploration when awarding scientific grants. I spent a decade writing a book on the cancer war—the subtitle of which is so blunt that it has angered many. (People do seem to like the title, though.) And when the Obama administration launched its cancer moonshot earlier in the year, I offered some not-so-shy advice about where it should start.
I mention all this because, in the past 10 months or so, the White House’s Cancer Moonshot Task Force—led by Vice President Joe Biden—has done a remarkable job not only in framing the most substantive challenges of this quest, but in beginning to tackle some of them in earnest. Harnessing the power of huge amounts of data is part of the challenge. In one program that has gotten scant attention, for example, researchers are using advanced supercomputers at the Department of Energy’s National Labs to analyze more than half a million medical records from one of the largest research cohorts in the world, the Million Veteran Program—an effort that might identify novel biomarkers or otherwise shed light on the disease. The National Cancer Institute is likewise borrowing the DOE’s computational expertise for three more promising pilots. Yeah, it’s nice when government agencies play nicely together in the same sandbox.
In another program, the U.S. Patent and Trademark Office is testing a new procedure it hopes will slice in half patent-review times in key areas of cancer therapy. The USPTO used crowdsourcing to select algorithms that could best analyze federal funding data and find areas where there has been genuine innovation. “They’ve been wonderfully aggressive in accelerating reviews of cancer-related patents,” one knowledgeable insider tells me.
There are other models that are working well in the broader cancer fight—from the Multiple Myeloma Research Foundation to the Parker Institute for Cancer Immunotherapy—which I’ll dive into more deeply in future essays. But for now, this cranky critic is giving a Friday shout-out to tireless Joe Biden and his ambitious moonshot. Way to go, Joe. Read some of these Medium posts for more.
Below, the day’s news from Sy.
Myovant has 2016's biggest biotech IPO—and a female CEO. Myovant raised $218 million in a blockbuster IPO that pegs the company's total value at around $878 million. The public offering was orchestrated by biotech investor wunderkind Vivek Ramaswamy, a 31-year-old whose companies have fostered equally massive valuations despite generally not having any approved products on the market (such as the $315 million IPO for Axovant that he pulled off last year). Myovant has a pair of assets (a prostate cancer drug and a female infertility therapy) that it snapped up from Japan's Takeda Pharmaceuticals in a stock-and-royalty deal. And Ramaswamy drew in some big talent for the newly public company's top perch: former Medivation chief medical officer Lynn Seely will serve as CEO, bringing her experience with the blockbuster prostate cancer drug Xtandi with her. After buyout interest from a slew of major pharma companies, Pfizer nabbed Medivation in a $14 billion deal earlier this year. (Forbes)
Bezos and Mayo Clinic pour major cash into biotech fighting aging diseases. Biotech upstart Unity Biotechnology took in an impressive haul from investors in a Series B round, drawing $116 million from the likes of Amazon chief Jeff Bezos' investment outfit Bezos Expeditions, the Mayo Clinic, Arch Venture Partners, Fidelity, and others. The firm is working in the increasingly popular (but risky) space of fighting diseases that are related to aging such as atherosclerosis (a buildup of plaque in the arteries). Other early-stage outfits doing similar aging-related research include Google's Calico. (FierceBiotech)
The FDA wants to figure out how animated drug ads affect consumers. The U.S. is one of just two developed nations that allows direct-to-consumer drug ads on television. A lot of them use animation to represent either the drug, the disease it treats, or the patient suffering from it. But how do all those cutesy little cartoons and animated figures actually affect consumers—and, specifically, do they have the potential to obscure the critical side effect and safety information that has to be included in the commercials? That's what the Food and Drug Administration is trying to find out through two new studies that will test 1,500 participants' responses to the ads (and how much information they retain). The agency's proposal, first unleashed in March, is now on the Federal Register. (Fortune)
3D printed device could control ultrasound waves for surgeries. A team of Singaporean researchers has created a 3D printed device that could be used in surgical procedures, according to Mass Device. The product has potential as a noninvasive technology that uses the power of focused acoustic waves, and its 3D printing aspect allowed the developers to better control the exact types of waves they can create since the device's surface lens could be easily formed into any shape. (Mass Device)
AstraZeneca gets a dreaded FDA clinical hold. The British pharma giant shed about 5% of its market cap on news that the Food and Drug Administration had placed partial clinical holds on two late-stage trials for a pair of cancer drugs, durvalumab and tremelimumab, over bleeding concerns. It's a blow to AstraZeneca, which has been trying to elbow its way into the increasingly crowded cancer immunotherapy space that's currently being dominated by companies like Merck, Bristol-Myers Squibb, and Roche/Genentech. But the firm continued to sound an optimistic note, stressing that the clinical studies could still continue for existing participants and that the company still expects to present data on lung cancer. (Reuters)
Sanofi may finally be getting an edge over rival Novo Nordisk. Diabetes and insulin giant Novo Nordisk's shares plunged 14% in morning trading today as the Danish company lowered its earnings guidance. The reason for Novo's pessimism? A “significantly more challenging” pricing landscape for insulin in the U.S., where the backlash over high drug prices has emboldened insurers and pharmacy benefits managers to drive tougher bargains with drug makers. Novo CEO has been hailed as one of the best-performing CEOs in the world by groups like the Harvard Business Review, but the outgoing chief has had to weather a sharp decline in market cap over pricing concerns. Sanofi, meanwhile, saw shares surge 7% in morning trading thanks to a sunny full-year profit guidance after previously taking beatings for dampened expectations in its flagship diabetes and insulin unit. The French pharma has been buoyed by intense cost-cutting and reorganizations, as well as strong sales of its rare disease drugs. (Wall Street Journal, Fortune)
A sugar pill for migraines? The placebo effect is one of the most fascinating, and somewhat controversial, aspects of drug development and clinical testing. And a new head-to-head study raises a provocative question: have headache specialists been taking the wrong tact when it comes to treating migraines? Research published in the New England Journal of Medicine on Thursday suggests just that, as a placebo sugar pill proved just as effective as two generic prescription drugs in slashing the number of days that children suffered migraines. The findings may highlight the need for alternative treatments such as lifestyle changes as the go-to options for neurologists treating their migraine patients. (Associated Press)
Astellas snapping up Ganymed in $1.4 billion deal. Ganymed, an obscure German biotech that made waves at this year's American Society of Clinical Oncology (ASCO) meeting (the largest cancer conference in the world) with a promising experimental stomach cancer drug, has been purchased by Japan's Astellas in a deal worth up to $1.4 billion. Ganymed's therapy, IMAB362, used in conjunction with chemotherapy was able to significantly boost stomach cancer patients' overall rates compared with chemotherapy alone. The therapy may also have promise in bile duct, ovarian, and lung cancers thanks to the specific type of protein that it targets. (Fortune)
THE BIG PICTURE
Aetna revenue and profits rise, but no thanks to Obamacare. Insurance giant Aetna, which stunned the Obama administration by ditching its Obamacare expansion plans earlier this year, reported third quarter earnings that included a rise in revenue and profit. But the insurer was careful to point out that its individual insurance unit which deals with the Obamacare marketplaces was still facing stiff headwinds. The rise in revenue and profit was thanks to its managed care plans for Medicare and Medicaid and an increase in fees. (Wall Street Journal)
Obama holds massive conference call to rally Obamacare supporters. With his signature domestic achievement under siege, President Obama held a conference call with more than 25,000 volunteers and Obamacare advocates in an effort to rally the troops on Thursday. Obama acknowledged the headwinds going into the upcoming open enrollment season for Affordable Care Act individual plans. "I think we’re at a critical time where we have to show that this program works for people, if they just see what their options are," he said. While benchmark plans sold through Obamacare marketplaces will see an average 25% premium increase in 2017, federal subsidies which offset those hikes for the vast majority of consumers will also rise in tandem. Still, millions of people who don't get that sort of financial assistance could face a major pinch. (Fortune)
Mylan execs probably won't be getting a haircut over massive settlement. Mylan agreed to shell out $465 million in a settlement with the federal government over whether or not it had improperly overcharged Medicaid for its flagship EpiPen. But that's unlikely to take a toll on CEO Heather Bresch and other executives' incentive pay, even though the legal fee accounts for nearly half of annual EpiPen sales. The reason? The way that Mylan (and other companies) report their adjust earnings, which doesn't take such expenses into account. (Fortune)
California rule about violence against health workers could become a model. California regulators have approved a new rule that will require medical providers to develop official standards to prevent violence towards health care workers. The regulations, which could take effect as soon as 2017, are aimed at preventing workplace violence that can lead to tragic incidents like the strangling of a psychiatric facility nurse in 2010. (NPR)
Martin Shkreli Does Not Apologize, by Ian Mount
GE Is in Talks on a Deal with Baker Hughes, by Reuters
Why One Startup Is Bringing Back the Doctor's House Call, by Kia Kokalitcheva
Mylan's EpiPen Price Hikes Reportedly Add Millions to Pentagon Costs, by Reuters