domingo, 21 de julio de 2019

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes

Late last week, a U.S. District Court judge in Maryland issued a decision that, among other things, requires makers and importers of e-cigarettes and other electronic nicotine delivery systems (ENDS) and certain other tobacco products like cigars, pipe tobacco and hookah to submit applications for their currently marketed products to the agency within 10 months.

This court decision comes at a time when I, like many others, are tremendously concerned about the rising use of e-cigarettes among our nation’s youth and especially the potential for them to become traditional cigarette smokers. We cannot allow the next generation of young people to become addicted to nicotine because of e-cigarettes. I am all too aware of the staggering toll inflicted on the public health by tobacco products. As someone who has dedicated my life to reducing the public health burden and suffering caused by cancer, the importance of preventing youth addiction to nicotine rings especially true to me.

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Takeda's plot to catch up in IO

Takeda knows it was late to the immuno-oncology revolution. But when it came time to catch up, “we did not want to be the 16th, 17th, or 18th company with” an analog to Keytruda, said Phil Rowlands, the company’s head of cancer R&D. Instead, the roughly $55 billion Japanese drug maker decided to make the riskier choice, investing in early-stage ideas that could become the next generation of cancer care.

About three years into the process, those bets are beginning to take shape. The most recent is a spin on CAR-T that leans on the Nobel Prize-winning work of Shinya Yamanaka. The idea is to turn Yamanaka’s induced pluripotent stem cell cells — or iPSCs — into T cells and then do the familiar genetic engineering that transforms them into cancer killers. Takeda believes its so-called iCAR-Ts would be about 10,000-fold quicker to produce than first-generation therapies, which are drawn from patients, and more predictable than other off-the-shelf ideas, which rely on healthy donors whose T cells can vary in viability.

Takeda’s iCAR-Ts, still a year or so from human trials, are part of a multi-pronged effort to ensure that while the company missed the first wave of immuno-oncology, it’ll play a role in the next, Rowlands said.

Remember Elon Musk’s brain-computer company?

Remember Elon Musk’s brain-computer company?

It’s called Neuralink, and for the past two years, it’s been toiling away on, according to its website, “ultra-high bandwidth brain-machine interfaces to connect humans and computers.”

Tonight, the world will get a better idea of what that means. At 7 p.m. PT, Neuralink says it will “share a bit” of its work, which, depending on whom you ask, will be new ways of measuring brain activity, chips that can be implanted into the skull, or literally controlling animals with a computer.

Anyway, STAT’s Rebecca Robbins will be there for the reveal, so look forward to news, provided she and the rest of the attendees are not held hostage by a vengeful monkey cyborg. Also it will be livestreamed.

Why GlaxoSmithKline's positive trial news matters

When GlaxoSmithKline bought Tesaro for $5 billion last December, one of management’s big arguments in favor of the deal was that the company's lead drug, Zejula, would be useful in many more cancers than investors expected. Zejula inhibits a protein called PARP, which is involved in repairing DNA. So far, it has proved useful mainly in cancers that are caused by mutations in the BRCA gene, the same one that causes breast and ovarian cancer. But GSK argued that there are cancers where Zejula would work in a larger group of patients.

At the time, STAT's Matthew Herper peppered GSK with questions on the reasons for its confidence. Were there other trials that would prove the company's case? Did GSK have data from its genomics efforts, which it had been talking up, that others didn't have? What made this worth a $5 billion bet?

The most important of those studies, GSK Chief Scientific Officer Hal Barron said, was one called PRIMA, which would test whether using Zejula in front-line ovarian cancer, before other drugs, would slow the cancer's progress in patients who tested positive for homologous recombination defect, or HRD.

On Monday, GSK announced that this ovarian study was positive not only in ovarian cancer patients with BRCA mutations, or who tested positive for HRD, but in the entire group as well.

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How pharma outfoxed its foes in D.C.

Despite bipartisan support, bicameral effort, and biting commentary from the White House, Washington’s attempts to rein in drug pricing have thus far come to naught. And that’s a testament to the undiminished power the pharmaceutical industry wields in the capitol.

As STAT’s Nicholas Florko and Lev Facher report, drug companies and their fleets of lobbyists worked behind the scenes to spike legislation, water down bills, and get lawmakers to about-face on drug pricing, scuttling policy changes while voters clamor for cheaper medicine.

“They have an incredible power to squash out any negative opinion, not to feel any of the ill effects of those things,” said Pallavi Damani Kumar, an American University crisis communications professor. “It just speaks to how incredibly savvy they are.”

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