Cancer
A new drug for glioma means a windfall for Agios
From STAT's Matt Herper: The FDA yesterday approved a new drug from for glioma, a type of brain tumor, provided the cancer's cells have mutations in the genes IDH1 or IDH2. It's the first time in two decades that a new drug for glioma has been approved.
In a clinical trial, the medicine, Voranigo, dramatically affected the growth of these incurable brain tumors, slowing the time it took for the cancer to progress
from 11.1 months to 27.7 months.
Voranigo's price is $39,881 per month. While it represents a medical advance, it's also an example of the kind of complicated financial deals that can surround a new medicine. It was initially developed by Agios Pharmaceuticals, of Cambridge, Mass. But in 2020 Agios sold its cancer medicines to Servier, the French drugmaker, for up to $2 billion. But Agios still had the rights to a royalty on the drug. In May, Agios inked a deal to sell much of its royalty in Voranigo to Royalty Pharma. Now, because of the FDA approval, Agios will receive $905 million from Royalty and $200 million from Servier.
earnings
Amgen ups investment in obesity, but says little else
When reporting earnings yesterday, Amgen raised its guidance for capital expenditures this year (from $1.1-$1.2 billion to $1.3 billion) as it expands manufacturing capacity for its experimental obesity drug MariTide.
Investors are closely watching MariTide, after executives earlier this year said that they were "very encouraged" with an interim analysis of a Phase 2 trial of and that they're planning a "broad" Phase 3 program to study the treatment in obesity, obesity-related conditions, and type 2 diabetes. The company said yesterday it will also start a Phase 2 trial focused on patients with diabetes.
Amgen fielded a slew of questions about MariTide on the call, on topics such as the drug's performance on measures of cardiovascular health like lipids and blood pressure, potential muscle loss in patients taking on the treatment, and when exactly the Phase 3 program will start. But Amgen stayed tight-lipped, saying it would not disclose any more data or details on the Phase 3 program.
For more on the key questions for MariTide going forward, here's an explainer I did earlier this year.
Amgen also said that it has been evaluating several preclincial obesity candidates, both oral and injectable and some with mechanisms that aren't related to GLP-1, and it will move a candidate into the clinic later this year.
earnings
Illumina tries to reassure investors ahead of strategy update
From STAT's Jonathan Wosen: Illumina sought to reassure investors yesterday that the company is well-positioned to weather what continues to be a rocky market for genomics companies. On an earnings call, executives noted that Illumina's core business brought in $1.1 billion in revenue during the second quarter, beating expectations. They added that the firm shipped 62 units of its newest line of high-end sequencers, the Nova Seq X series, during this period.
But the company also lowered its revenue guidance for the year from essentially flat to down 2-3% for Illumina's core business. That change is driven by an expected slowdown in business in Asia, as well as by customers being slower to buy new instruments, especially mid-range DNA sequencers, CEO Jacob Thaysen said. "There are still many moving elements in the global economy, and we are taking a more measured view," he said.
This comes as Illumina prepares for a strategy update next Tuesday that will lay out the company's future now that it has completed its divestment of cancer detection firm Grail.
devices
Turning a questionable screening program into a goldmine
UnitedHealth has pressed thousands of its doctors to use a thinly tested medical device to screen people for peripheral artery disease (PAD), dramatically boosting payments from the federal government for years even though many of the patients were not sick, a new STAT investigation finds.
The device, called QuantaFlo and made by Semler Scientific, was cleared as a tool to help doctors diagnose PAD, but not as a standalone diagnostic device. In many cases in which the device was used by UnitedHealth doctors, the diagnoses were not medically useful, either because they were false positives or because they flagged early-stage disease, which isn't typically treated, according to clinicians who spoke with STAT.
This is the second installment in an investigative series on how UnitedHealth wields its unrivaled physician empire to boost its profits and expand its influence.
Read more.
politics
Harris' VP pick boasts progressive health record
Yesterday, Vice President Kamala Harris announced that she had picked Minnesota Gov. Tim Walz as her running mate. My colleague Sarah Owermohle looked back at his health record.
Before becoming governor, Walz held a seat in Congress, where he voted for Medicare drug price negotiation and supported medical research of cannabis. In recent years as governor, he's positioned Minnesota as a Midwestern safe haven for access to abortions and gender-affirming care as surrounding states implement restrictions. Read more.
Separately, my colleagues took a deeper look at Walz's relationship with corporate interests in health care. They reported that as progressive as he has been, one powerful exception was the Mayo Clinic. Last year, Walz backed down on two bills to rein in health care costs and regulate hospital staffing, after Mayo threatened to send billions in planned investments in the state elsewhere. Read more on that here.
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