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Updated: 3 min 31 sec ago

Study finds racial bias in the government’s formula for distributing Covid-19 aid to hospitals

11 hours 27 min ago

The federal government has systematically shortchanged communities with large Black populations in the distribution of billions of dollars in Covid-19 relief aid meant to help hospitals struggling to manage the effects of the pandemic, according to a study published Friday.

The study in the Journal of the American Medical Association found that the funding inequities resulted from a formula that allocated large chunks of a $175 billion relief package based on hospital revenue, instead of numbers of Covid-19 cases or other health data.

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STAT Plus: FDA approves first oral treatment for a rare muscle-destroying disease

11 hours 57 min ago

The Food and Drug Administration on Friday approved the first oral therapy for spinal muscular atrophy, a rare and often devastating disease, adding a new option for patients who now rely on costly injected treatments.

The drug, from partners Genentech and PTC Therapeutics, is approved for adults and children with SMA, regardless of the severity of their disease. The once-a-day treatment will compete with a one-time gene therapy from Novartis and a drug from Biogen that is injected into the spine every four months.

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STAT Plus: Hospital president wrote opinion piece critical of drug pricing efforts, but didn’t disclose role on Moderna board

16 hours 30 min ago

Dr. Elizabeth Nabel, president of Brigham and Women’s Hospital, earlier this year criticized efforts to control drug prices in an opinion piece published in multiple newspapers, but she did not disclose her role as a highly compensated member of the board at Cambridge biotech Moderna.

Nabel was identified at the bottom of the article as Brigham and Women’s president, a Harvard Medical School professor, and a cardiologist. Some publications also noted that her husband, Dr. Gary Nabel, is chief scientific officer for the French drug giant Sanofi.

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STAT Plus: Up and down the ladder: The latest comings and goings

17 hours 17 min ago

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Melinta Therapeutics hired Christine Ann Miller as chief executive officer and president. Most recently, she was the global and U.S. product portfolio for the Sandoz unit at Novartis (NVS).

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STAT Plus: Pharmalittle: Trump’s ‘Buy American’ order raises doubts; Gilead looks to boost global remdesivir output

17 hours 35 min ago

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Given the circumstances, our agenda is rather modest. We plan to gaze at the telly now and then, promenade with the official mascot, putter around the castle, and catch up on our reading. And what about you? This remains a fine time to appreciate the great outdoors. Perhaps a drive-in movie is a possibility. Or you may want to reach out to someone feeling a bit isolated these days. Well, whatever you do, have a grand time. But be safe — wear a mask. Enjoy, and see you soon…

President Trump signed an executive order Thursday directing the federal government to buy certain drugs solely from American factories, STAT reports. The “Buy American” order could represent a seismic shakeup of the pharmaceutical industry. No one knows exactly how much of the American supply chain is produced abroad, but some experts insist up to 90% of critical generic drugs are made at least partially abroad. It remains unclear, however, how broadly the order will be implemented — the executive order does not specify what drugs it covers.

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The FDA accepted Biogen’s Alzheimer’s drug submission. Next up, a highly anticipated outside expert review

18 hours 13 min ago

The Food and Drug Administration has agreed to review a marketing application submitted by Biogen for aducanumab, its treatment for Alzheimer’s disease, the company announced Friday.

The aducanumab application was granted priority review, which means the FDA will render an approval decision no later than March 7, 2021.

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STAT Plus: AbbVie pays $24 million to settle lawsuit over using ‘nurse ambassadors’ to boost Humira sales

19 hours 9 min ago

After two years of wrangling, AbbVie (ABBV) agreed to pay $24 million to settle a lawsuit filed by the California insurance commissioner, who accused the drug maker of paying kickbacks to doctors and using a stealthy network of nurses to illegally boost prescriptions of its best-selling Humira treatment.

Over a five-year period, the drug maker offered physicians a familiar menu of tempting items, from cash, meals, and drinks, to gifts and trips, along with patient referrals, in hopes they would write more prescriptions for the rheumatoid arthritis medicine, according to the lawsuit. Humira is a franchise product for AbbVie and last year generated $14.8 billion in sales in the U.S. alone.

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Opinion: When the treatment is torture: ICE must stop using solitary confinement for Covid-19 quarantine

22 hours 9 min ago

After months of social distancing, many of us are feeling its effects. Experts have delineated the mental and physical health impacts of isolation caused by the pandemic, and those who have experienced home quarantine have been particularly vulnerable to loneliness and depression.

Imagine though, if quarantine meant you were confined to a single bare room and deprived of the things that could keep you happy and sane — video chats with loved ones, digital entertainment, a sense of purpose through work, and of course, occasional human contact.

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The story of a scientist’s mea culpa on Covid-19 vaccines — and a rough week on Twitter

22 hours 14 min ago

The development of Covid-19 vaccines is progressing at an unprecedented speed. Vaccines that were mere blueprints in January when the coronavirus began spreading globally already have advanced into massive Phase 3 clinical trials. The U.S. government wants hundreds of millions of doses of Covid-19 vaccine or multiple vaccines ready to distribute by January.

Many experts have raised concerns about this highly compressed development schedule. But this week, Steven Salzberg, a Johns Hopkins University professor and biomedical engineer, took the opposite tack. Writing in Forbes, Salzberg said that we should be reasonably confident already about the safety and efficacy of experimental Covid-19 vaccines and that we should start inoculating millions of Americans today.

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Nursing homes grapple with a dual crisis: preparing for hurricane season amid the Covid-19 pandemic

22 hours 19 min ago

Nursing homes face an impossible decision during hurricane season this year — whether or not to evacuate their residents amid the Covid-19 pandemic, risking the health and well-being of their patients and staff in the process.

Even in normal times, evacuation decisions are tough: Research shows that moving frail residents can exacerbate already burdensome health conditions and increase hospitalizations. But failing to evacuate can leave residents vulnerable to power outages, flooding, and even death. This year, as the coronavirus pandemic rages across the Southeast in particular, that decision is even harder — hospitals are already overburdened and social distancing isn’t necessarily possible in evacuation vans or temporary shelters.

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As mindfulness app Headspace booms, its popularity outpaces its scientific evidence

22 hours 24 min ago

This has, by all accounts, been a banner year for Headspace.

Demand for the mindfulness and meditation app has skyrocketed since the Covid-19 pandemic and its ripple effects began taking a brutal toll on mental health. Downloads have jumped dramatically in recent months, and Headspace has been flooded with requests from companies looking to buoy their staffs’ well-being while they work from home.

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Listen: A health tech mega-deal, a Twitter vaccine debate, and media criticism from Operation Warp Speed

Thu, 08/06/2020 - 13:15

Does the future of health tech look like Facebook? Can we cut corners with Covid-19 vaccines? And are journalists slowing down Operation Warp Speed?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we talk about the implications of a big acquisition in health tech that will merge a telemedicine provider with a diabetes coaching company. Then, Johns Hopkins scientist Steven Salzberg calls in to discuss his whirlwind week on the Internet after a blog post on Covid-19 vaccines became a lightning rod. Finally, we delve into just how much those vaccines might cost and whether nosy journalists are making the process take longer than it otherwise would.

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STAT Plus: Italy becomes first country to require pharma to disclose public funding for R&D costs

Thu, 08/06/2020 - 12:46

Amid growing clamor for more transparency from the pharmaceutical industry, Italy has become the first country to require drug makers to disclose data about public funding for any of their medicines during negotiations over pricing and reimbursement.

As a result, the Italian Medicines Agency, known as AIFA, will have insight into various costs, such as R&D and marketing, that drug companies incur, as well as data on revenue, patents, and prices offered to other countries, according to a decree published last week. The decree is notable, in part, because Italy is a Group of Seven country with a significant market for the global pharmaceutical industry.

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STAT Plus: Pressure mounts on FDA chief to stick with science for Covid-19 vaccine approvals

Thu, 08/06/2020 - 10:27

As pressure mounts to develop a successful Covid-19 vaccine, Food and Drug Administration Commissioner Stephen Hahn insisted any agency approval would “adhere to standards” that ensure safety and effectiveness. But Hahn left the door open to a so-called emergency use authorization, raising concerns the FDA might still face political pressure to approve a vaccine before the November elections.

His remarks appeared late Wednesday in an op-ed in the Washington Post just as nearly 400 health experts and scientists released an open letter that was sent to Hahn and urged a “transparent and rigorous FDA approval process that is devoid of political considerations.” The letter was organized by the Center for Science in the Public Interest.

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STAT Plus: Biogen strikes $1 billion deal with Denali to advance Parkinson’s drug based on approach that was nearly abandoned

Thu, 08/06/2020 - 07:57

Biogen said Thursday it will pay more than $1 billion to the biotech firm Denali for rights to a Parkinson’s drug based on an approach that was nearly abandoned by several major pharmaceutical firms in recent years but that has since shown potential to help treat the disease. The deal also includes rights to a Denali technology for delivering medicines to the brain.

“This is a major milestone,” said Ryan Watts, Denali’s CEO and co-founder. He said the company had “the firepower to do very thorough science and drug development,” which meant that it also had the wherewithal to previously move beyond the failure of other promising programs.

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Trump to order government to buy certain drugs solely from U.S. factories, setting up major shakeup for industry

Thu, 08/06/2020 - 07:01

WASHINGTON — President Trump will sign an executive order Thursday directing the federal government to buy certain drugs solely from American factories.

Trump is expected to sign the executive order at the Whirlpool Corporation in Ohio at 3:15 p.m.

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STAT Plus: Pharmalittle: AstraZeneca strikes first Covid-19 deal with a Chinese company; vaccine trials face distrust from minority groups

Thu, 08/06/2020 - 06:27

Good morning, everyone, and how are you today? We are doing just fine, thank you, despite the overcast skies hovering above the Pharmalot campus. Our official mascot is curled up nearby and snoozing happily. And the coffee kettle is whistling once again in preparation for another delicious cup of stimulation. In other words, the proverbial coffee cup is half full. Better than half empty, yes? On that note, it is time, once again, to get cracking. Here are a few tidbits to help you on your journey. Hope today goes well, and do keep in touch. …

Shenzhen Kangtai Biological Products will produce a Covid-19 vaccine in mainland China that is being developed by AstraZeneca (AZN), its first deal to supply one of the world’s most populous countries, Reuters notes. The deal underscores a global race to deliver an effective vaccine, given that Chinese ventures are leading at least eight of the 26 global vaccine development projects currently testing in humans. Under the deal, Shenzhen Kangtai will ensure it has annual production capacity of at least 100 million doses of the experimental shot.

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Opinion: As clinicians are redeployed for Covid-19, onboarding takes on extra importance

Thu, 08/06/2020 - 01:45

Think back to your first day at a new job. It was probably difficult to remember who was who or the steps for logging into the network, let alone keep track of where the coffee or the printers or the bathrooms were.

Now imagine you are a clinician and the new job is taking care of Covid-19 patients using new or refreshed skills in an unfamiliar ward or intensive care unit.

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This California company has a better version of a simpler, faster Covid-19 test

Thu, 08/06/2020 - 01:35

In some parts of the U.S. right now, it can take weeks to get results for a simple Covid-19 test, a delay that renders the results largely useless.

So a handful of city governments and schools are turning to an entirely different type of Covid-19 test that they say is simpler, easier, and most importantly faster — and therefore more meaningful.

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How a Zoom forum is changing the way ICU doctors treat desperately ill Covid-19 patients

Thu, 08/06/2020 - 01:30

It was late April, near the height of the Covid-19 pandemic in the big cities in the northeastern U.S., and anesthesiologist Joseph Savino was puzzled. In two months, an unexpectedly high number of coronavirus patients had died in his intensive care unit at the Hospital of the University of Pennsylvania after a stroke caused by bleeding in the brain.

All were among 15 Covid-19 patients at the Philadelphia hospital who had been on a life-support technology called ECMO that is a last resort for patients when mechanical ventilators fail to help their virus-ravaged lungs.

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