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Updated: 3 hours 2 min ago

Listen: Elon Musk’s monkey cyborg, Gilead’s shifting future, & an app for anxiety

4 hours 1 min ago

Can apps treat anxiety? Is Gilead Sciences back on track? And are we all just brains in a vat?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, we dig into Elon Musk’s brain-computer interface company and the bombastic announcement of its futuristic intentions. Then, we discuss Gilead’s $5 billion effort to reverse its recent fortunes. Later, STAT’s Megan Thielking joins us to discuss the complexity of designing apps to deal with mental health issues. Finally, we embark upon a lightning round, featuring sea-sick volunteers, big-money startups, and experimental eye surgery.

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STAT Plus: Pharmalittle: Women make ‘little progress’ in key pharma roles; FDA approves a Merck antibiotic

9 hours 39 min ago

Rise and shine, everyone, another busy day is on the way. And this will be an especially busy one for us as we engage in a round of chats with a multitude of interesting folks. A break from the usual routine, in some ways. Nonetheless, we continue to forage for interesting items, despite the oppressive heat. So time to stay cool with another hot cup of stimulation, yes? As always, please feel free to join us. Meanwhile, here is a new batch of tidbits to help you along. Hope all goes well today and do stay in touch. …

“Little to no progress” has been made in achieving gender representation in the pharmaceutical industry, Pharmafile writes, citing a new report. Female representation on executive committees tripled to 26%, up from 8% in 2018, but representation in roles with profit and loss responsibility had halved over the same period to 4%, and representation of female executive directors on boards fell to 6% from 10%. Given these rates of change, the report estimated that it would take until 2090 before gender parity was reached in the industry.

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STAT Plus: Archived: An online chat discussing the past — and future — of Alzheimer’s research

10 hours 15 min ago

After decades of attempts to develop treatments for Alzheimer’s disease, scientists still have precious little to show for it. Now, after some high-profile failures, there are big questions about where researchers can turn next.

Join STAT senior science writer Sharon Begley and STAT senior medicine writer Matt Herper for a subscriber-only live chat on Alzheimer’s research, the beta-amyloid theory, and the effort to develop new therapies. They’ll also be discussing the latest news out of the Alzheimer’s Association International Conference.

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STAT Plus: Novartis sets aside $700 million to settle long-running bribery allegations in the U.S.

11 hours 16 min ago

Novartis (NVS) has set aside $700 million to settle a long-running lawsuit in which the federal government alleged the drug maker used kickbacks to doctors — including fishing trips, lavish meals and “sham” speaking events — in order to boost prescriptions of several medicines a decade ago.

A trial had been scheduled to start in in federal court in New York this past May. At the time, however, STAT reported the trial was delayed as the company began negotiating with federal prosecutors and Novartis might pay close to $1 billion in order to settle the case.

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STAT Plus: Kronos, a startup led by Gilead alumni, raises $105 million in latest mega-round

13 hours 24 min ago

Norbert Bischofberger, a former Gilead executive, has been running Kronos Bio for a little more than a year — and it’s been a year full of changes. The company has a fresh logo, programs inching closer to clinical trials, and more than $100 million of new money from a financing round announced Thursday.

Kronos, which has offices in Cambridge, Mass., and near San Francisco, is hoping to find new small-molecule drugs for cancer using a novel method for screening potential drug targets.

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Opinion: Personalized treatments may be threatened by drug cost-containment proposals

14 hours 43 min ago

President Trump has said he plans to issue an executive order to lower what the United States government would pay for drugs to no more than “whatever the lowest nation’s price is.” The proposal is designed to end what he has called “global freeloading,” whereby Americans pay more for drugs than residents of other countries.

The executive order announcement follows an earlier proposal by the Trump administration to decrease the price of physician-administered therapies by tying them to an international price index so their prices will not exceed those charged in other countries.

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Opinion: A bird’s-eye view of clinical trials provides new perspectives on drug research and development

14 hours 49 min ago

Waste and inefficiency in drug development are big problems. They can be hard to spot, especially when you are in the midst of the process. A new way of visualizing clinical trials might help.

Some experts believe that as much as 85% of biomedical research may be wasteful due to biases in study design, lack of publication, unnecessary duplication, or investigating questions of little importance. It is also estimated that only about one (or maybe two) of every 10 drugs that enter into clinical testing will turn out to be effective.

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Do Elon Musk’s brain-decoding implants have potential? Experts say they just might

14 hours 53 min ago

SAN FRANCISCO — Okay, the “sewing machine” is pretty cool. But if the device that Elon Musk’s neurotechnology startup Neuralink developed to implant thousands of electrodes into brains (of rats and monkeys so far, and humans eventually) were its only accomplishment, Tuesday night’s big reveal would have been a big meh. Instead, five independent experts in the kind of brain-computer interfaces that Neuralink is developing told STAT they are impressed for the most part, though caveats abound.

“Overall, the concept is impressive and so is the progress they’ve made,” said neurobiologist Andrew Schwartz of the University of Pittsburgh Medical Center, a pioneer in the technology. “But a lot of this still seems to be conceptual. It’s hard to tell what’s aspirational and what they’ve actually done.”

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STAT Plus: Alector, with big ideas about treating dementia, presents a little bit of data

Wed, 07/17/2019 - 13:09

Alector, a South San Francisco-based biotech, raised $176 million in an initial public offering in February based on a bold idea: that the battle against Alzheimer’s disease and other forms of dementia may rely a lot more on the brain’s innate immune system than on targeting the misfolded proteins that have been the pharmaceutical industry’s main targets so far.

“The immune system is a lot more versatile than our drugs,” said Alector chief executive and co-founder Arnon Rosenthal.

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Scientists find new way to kill disease-carrying mosquitoes

Wed, 07/17/2019 - 12:19

NEW YORK — Scientists say they nearly eliminated disease-carrying mosquitoes on two islands in China using a new technique. The downside: It may not be practical for larger areas and may cost a lot of money.

In the experiment, researchers targeted Asian tiger mosquitoes, invasive white-striped bugs that can spread dengue fever, Zika, and other diseases. They used a novel approach for pest control: First, they infected the bugs with a virus-fighting bacterium, and then zapped them with a small dose of radiation.

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An experimental AI system can predict when pancreatic cysts will become cancerous

Wed, 07/17/2019 - 11:00

Pancreatic cancer often kills people because they are diagnosed too late, after their tumors have spread. Other patients may die following the removal of harmless cysts that appear threatening amid a fog of imaging data and other clinical information.

But a new artificial intelligence system unveiled Wednesday by doctors at Johns Hopkins offers to provide a clearer picture for patients: In testing, it displayed a superhuman ability to differentiate harmful lesions from ones that pose no threat at all.

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WHO declares Ebola outbreak an international health emergency

Wed, 07/17/2019 - 10:42

The World Health Organization declared the Ebola outbreak in the Democratic Republic of the Congo a global health emergency on Wednesday, a move that is likely to escalate international attention on a crisis that has flared for a year despite aggressive efforts to stamp it out.

The declaration, which critics have contended is long overdue, could increase the amount of funding and assistance other countries are willing to provide to the response effort.

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STAT Plus: Pharma deploys its top guns to Capitol Hill as senators mull drug pricing package

Wed, 07/17/2019 - 09:56

WASHINGTON — The pharmaceutical industry deployed its top guns to Capitol Hill on Wednesday as senators pushed to find consensus on a major package of drug pricing reforms.

Spotted in the Senate basement at lunchtime: Stephen Ubl, the head of the industry lobbying organization PhRMA, and Dr. Giovanni Caforio, the CEO of Bristol Myers-Squibb.

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STAT Plus: An Indian drug maker sent records to its scrapyard before the FDA visited

Wed, 07/17/2019 - 08:06

As concerns persist over the quality of medicines made in Asia, a recent episode involving Strides Pharma, one of the largest purveyors of generic drugs, illustrates the extent of the problem.

A week before a Food and Drug Administration investigator arrived at a facility in Puducherry, India, the company had discarded documents, including batch records, in a 55-gallon drum in its scrapyard. “Multiple bags” of documents pertaining to drug productions, quality, and laboratory operations were “awaiting shredding,” according to a July 1 warning letter posted this week on the agency web site.

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STAT Plus: Frequency signs $80 million deal with Astellas Pharma

Wed, 07/17/2019 - 07:32

Frequency Therapeutics, the Woburn, Mass., biotech that wants to restore hearing lost as a result of long-term exposure to loud music, leaf blowers, and other features of modern life, has found a like-minded business partner in Japan.

Frequency will receive $80 million up front in a licensing deal with Tokyo-based Astellas Pharma (ALPMY). The latter firm hopes to develop and market outside the United States the startup’s experimental drug to restore hearing. Frequency plans to develop and sell the medicine domestically.

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STAT Plus: Pharmalittle: Data show pharma saturated U.S. with opioids; Swiss extradite Chinese researcher

Wed, 07/17/2019 - 06:40

Rise and shine, everyone, the middle of the week is already here. Time moves quickly, yes? Of course, this is good reason to hang in there, since the end of the week cannot be too far away. Besides, what are the alternatives? And do you really want to know? Meanwhile, we are digging in for another busy day of foraging. So time to get cracking. Hope you have a simply smashing day and conquer the world. Meanwhile, here are some tidbits. Good luck. …

Drug makers saturated the country with 76 billion opioid pills from 2006 through 2012, the Washington Post writes, citing newly disclosed data from a Drug Enforcement Administration database released as part of the opioid litigation. Just six companies distributed 75% of the pills: McKesson (MCK), Walgreens (WBA), Cardinal Health (CAH), AmerisourceBergen (ABC), CVS (CVS), and Walmart (WMT). Three companies manufactured 88% of the opioids: SpecGx, a unit of Mallinckrodt (MNK); ­Actavis Pharma, which is now part of Teva Pharmaceuticals (TEVA); and Par Pharmaceutical, a subsidiary of Endo Pharmaceuticals (ENDP).

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Elon Musk wants to test brain-reading implants in paralyzed patients next year

Wed, 07/17/2019 - 02:09

SAN FRANCISCO — In front of a crowd of techies packed into a planetarium, Elon Musk strode out on stage, waxed philosophical about achieving symbiosis with artificial intelligence, and made his latest ambitious pronouncement in a career that’s been full of them: His startup Neuralink has developed technology meant to be implanted into the brain that’s designed to allow people to operate computers and smartphones with their thoughts.

With some early animal testing under its belt, Neuralink wants to start human testing of its so-called “brain-machine interface” in paralyzed patients by the end of next year. Notably, the startup has yet to convince the Food and Drug Administration to allow it do so, said Musk, who has tangled with regulators over his other companies Tesla, SpaceX, and the Boring Company. 

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Opinion: I get asked a lot about longevity. It helps that I’m 104

Wed, 07/17/2019 - 01:45

As scientists pursue longevity and anti-aging research, and as more people are living to 100, we wanted to hear from a centenarian on her life experience and thoughts on aging. STAT editor Sarah Mupo spoke with 104-year-old Missouri resident Virginia Leitner. Their conversation forms the basis for this brief oral history.

When anyone meets me for the first time, they always ask me, what do you attribute your longevity to? And I always say, just don’t tell me to be good, because I want to dance and have fun.

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Opinion: It’s time to change the definition of ‘health’

Wed, 07/17/2019 - 01:40

Meet Betty, a typical aging American. At 82, she spends almost as much time with her doctors as she does with her grandchildren. She has to. She takes seven prescription medications to treat her high blood pressure, high cholesterol, diabetes, and arthritis. Ten years ago, she was treated for breast cancer.

Is Betty healthy? According to her, “Absolutely!” She enjoys her spacious apartment, two cats, close friends, and 50-gallon fish tank.

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Debate over whether to test a second Ebola vaccine turns acrimonious

Wed, 07/17/2019 - 01:35

An aggressive push to use a second experimental Ebola vaccine to try to help stop the nearly yearlong outbreak in the Democratic Republic of the Congo may have backfired, with the DRC’s health minister insisting the country will not allow use of the vaccine, made by pharmaceutical giant Johnson & Johnson.

The health minister, Dr. Oly Ilunga, had previously suggested a consortium made up of the London School of Hygiene and Tropical Medicine, Doctors Without Borders, and others might be permitted to conduct a clinical trial of J&J’s Ebola vaccine in the country, although not in the outbreak zone, where Merck’s experimental vaccine is being used.

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