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STAT Plus: With hopes running high for Moderna’s coronavirus vaccine, the stock’s value requires an almost mythical leap of faith

Tue, 05/12/2020 - 01:40

Moderna is moving at unprecedented speed to develop a vaccine to prevent infection from the novel coronavirus. But the biotech’s soaring stock price is moving faster, which raises an important question: Are investors taking on too much risk?

Since late February, Moderna shares have more than tripled in value — making it one of the top-performing biotech stocks this year. On Monday, shares hit an all-time high of $66.

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Covid-19 has streamlined addiction medicine. Will the changes stick?

Tue, 05/12/2020 - 01:35

Nicole Godinez’s monthly visit to an addiction clinic typically takes several hours: To start, there’s the 35-minute drive to a Nashville suburb, the waiting room, and the paperwork. Then the repetitive questioning from a drug counselor, then the drug test. Finally, there’s the in-person visit with a doctor who refills her 28-day prescription for Subutex, a common but highly controlled medication used to treat opioid dependence.

But in March, Godinez was sure she’d miss the appointment. She’d just delivered twins by C-section, and couldn’t drive. One of her 3-week-old boys was still in intensive care, and she refused to leave his side. And then, of course, there was the pandemic. In the previous two weeks, health officials across Tennessee had reported 4,500 new coronavirus cases. Godinez thought she’d be forced to make an impossible choice: Her own care, or potentially exposing herself and her twins to Covid-19.

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A secret experiment revealed: In a medical first, doctors treat Parkinson’s with a novel brain cell transplant

Tue, 05/12/2020 - 01:30

A month before the scheduled surgery, the four researchers were ready to chaperone the brain cells on their 190-mile journey. They never anticipated they were in for “The Amazing Race”-meets-“ER.”

It was after midnight on a late summer night in 2017, and they had less than eight hours to get the cells by ambulance, private plane, and another ambulance from Dana-Farber Cancer Institute in Boston to Weill Cornell Medical Center in Manhattan. If it took longer, the cells would almost certainly be DOA, and so might the researchers’ plan to carry out an experimental transplant surgery unprecedented in the annals of medicine: replacing the dysfunctional brain cells of a Parkinson’s disease patient with the progeny of an extraordinary type of stem cell. Created in the lab from a patch of the patient’s own skin, these cells, it was hoped, would settle into the brain like they belonged there and permanently restore the patient’s ability to walk and move normally.

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French drug maker Genfit says NASH drug fails late-stage clinical trial

Mon, 05/11/2020 - 13:55

French drug maker Genfit said Monday that its lead drug, elafibranor, failed to improve outcomes for patients with the fatty liver disease NASH, according to an interim analysis of a late-stage clinical trial.

“These results are highly disappointing,” Genfit CEO Pascal Prigent said in a statement. The company plans to review additional data and consult with regulators before determining if development of elafibranor should continue.

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STAT Plus: Prominent Broad Institute scientist leaves to lead R&D at Genentech

Mon, 05/11/2020 - 12:32

A star scientist in the world of single-cell genomics and computational biology is leaving academia to become one of the few women leading R&D at a biotech company.

Aviv Regev, a core institute member of the Broad Institute of MIT and Harvard, will become head of Genentech research and early development effective Aug. 1, its parent company, Roche (RHBBY), announced Monday. She will join the Swiss biopharma company’s corporate executive committee and report to Roche CEO Severin Schwan.

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New research sheds light on sex imbalances in diseases like schizophrenia and lupus

Mon, 05/11/2020 - 11:50

There’s a clear sex bias in many diseases. Lupus, for instance, affects women nine times more often than it does men. Schizophrenia tends to be far more severe in males.

But what’s behind the imbalance? A new paper in Nature helps unravel why some conditions might manifest themselves more commonly, or intensely, in one sex over another. And it suggests that new therapies might be developed with these sex-based molecular disparities in mind. 

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STAT Plus: Pharmalittle: Hackers linked to Iran sought Gilead Covid-19 data; NIH to test remdesivir with a Lilly drug

Mon, 05/11/2020 - 06:28

Hello, everyone, and welcome to another working week. We hope the weekend respite was sufficiently distracting, if not restful, given that what now constitutes the usual routine has returned. By this we mean Zoom calls and more Zoom calls, and deadlines and those sorts of things. To cope, yes, we are firing up the coffee kettle and reaching for a cup of stimulation. Our choice today is old-fashioned hazelnut. Feel free to join us. Meanwhile, here are a few tidbits to get you going. Hope your day goes well, and stay safe. …

Hackers linked to Iran have targeted staff at Gilead Sciences (GILD) in recent weeks, according to publicly available web archives reviewed by Reuters and three cybersecurity researchers, as the company races to deploy an experimental treatment for the Covid-19 virus. In one case, a fake email login page designed to steal passwords was sent in April to a top Gilead executive involved in legal and corporate affairs, according to an archived version on a website used to scan for malicious web addresses. Reuters was not able to determine whether the attack was successful.

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STAT Plus: Hospitals are reluctant to share data. A new effort to map brain tumors with AI is getting their help another way

Mon, 05/11/2020 - 06:00

It’s a contradiction that’s long slowed the forward march of artificial intelligence in medicine: Machine learning models need to be trained on lots of diverse data from hospitals around the world — but those hospitals are often reluctant to ship out their data due to privacy concerns, legal issues, and a cautious culture.

One promising way to get around that problem is a technique known as federated learning, which allows models to be trained without having to share data to a central server or in the cloud. Now, the approach is being put to the test in an ambitious project to build an AI system from thousands of brain tumor scans from several dozen hospitals and research institutions around the globe.

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STAT Plus: Results indicate MyoKardia drug is a ‘potential game changer’ for heart condition

Mon, 05/11/2020 - 04:30

An experimental drug to treat an inherited, progressive heart disease clearly improved the symptoms of patients, its maker, MyoKardia, said Monday.

The full data have not yet been published or reviewed by outside experts. But cardiologists called the top-line results alone a big step forward for patients with the disorder, called hypertrophic cardiomyopathy, or HCM. In the disorder, the wall of the left ventricle, the chamber of the heart that pumps blood throughout the body, thickens and the heart’s pumping action becomes less effective.

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STAT Plus: Atul Gawande to depart as CEO of splashy health venture. Is it ‘a death knell’?

Mon, 05/11/2020 - 01:50

It seemed an ideal partnership: Three of America’s most powerful companies were teaming up with one of its most celebrated physician writers to topple a health care system with out-of-control costs and mediocre patient outcomes.

But two years later, Atul Gawande is leaving the CEO role at Haven, the venture formed by Amazon, Berkshire Hathaway, and JP Morgan Chase & Co.

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Opinion: A global pathogen shield: the health security step to ‘never again’

Mon, 05/11/2020 - 01:45

In the name of strategic defense, the world’s nations have amassed enough nuclear weapons to destroy human civilization. We accept the massive financial investment involved. Yet no country has developed the capacity to protect itself against a novel, lethal infectious disease. It’s time to start.

Last week marked the start of a global pledging marathon that has so far raised more than $8 billion to end the Covid-19 pandemic. The hastily assembled coalition of governments, industry, and philanthropic organizations, backed by the G20, last month announced its aim to accelerate the development, manufacturing, and distribution of Covid-19 treatments, vaccines and diagnostic tests, making them accessible to everyone, worldwide.

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Opinion: Three traps for the unwary in HHS’ provider relief fund

Mon, 05/11/2020 - 01:40

In its rush to offer a lifeline to U.S. health care providers struggling under the crushing financial impact of the Covid-19 crisis, the federal government has unleashed a provider relief package that may do more harm than good.

The problem? A flawed distribution process that has already resulted in the improper distribution of $30 billion through automated direct deposits, setting unwary providers up for a legal quagmire.

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14 questions for Fauci, Redfield, and the other Trump officials testifying on the U.S. coronavirus response

Mon, 05/11/2020 - 01:35

The Trump administration figures who’ve led the federal government’s coronavirus response have escaped the wrath — and even the questions — of Congress.

Until now. On Tuesday, Anthony Fauci, Robert Redfield, Stephen Hahn, and Brett Giroir are set to testify before the Senate’s main health committee. They’ll come face to face (or Zoom-to-face) with lawmakers who’ve been outspoken in their criticisms of the Trump administration’s coronavirus response, including Sens. Elizabeth Warren (D-Mass.), Bernie Sanders (I-Vt.), and Patty Murray (D-Wash.).

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Inside the NIH’s controversial decision to stop its big remdesivir study

Mon, 05/11/2020 - 01:30

The drug maker Gilead Sciences released a bombshell two weeks ago: A study conducted by a U.S. government agency had found that the company’s experimental drug, remdesivir, was the first treatment shown to have even a small effect against Covid-19.

Behind that ray of hope, though, was one of the toughest quandaries in medicine: how to balance the need to rigorously test a new medicine for safety and effectiveness with the moral imperative to get patients a treatment that works as quickly as possible. At the heart of the decision was a process that was — as is often in the case in clinical trials — by turns secretive and bureaucratic.

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Trump administration announces plan to distribute Covid-19 drug amid concerns over allocation

Sat, 05/09/2020 - 08:12

WASHINGTON — The federal government on Saturday announced a plan to distribute remdesivir, the antiviral drug used as a Covid-19 treatment, following nearly a week of chaos and confusion surrounding which hospitals and which states would receive the medication, and how they were chosen. 

While some hospitals in recent days had reported receiving allocations of remdesivir directly, others received none, leaving many doctors and hospitals across the country frustrated and in the dark as to when and they might receive supplies.

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STAT Plus: A new Trump administration rule could increase out-of-pocket drug costs

Fri, 05/08/2020 - 12:53

Even as prescription drug costs remain an important pocketbook issue for many Americans, the Trump administration has taken a new step that will likely raise expenses for many patients, a move that consumer advocates find upsetting and puzzling.

As part of a final rule setting standards for health benefits, the Centers for Medicare and Medicaid will allow insurers and employers to exclude certain copay assistance programs, such as cards and coupons provided by drug makers, from counting toward deductibles and out-of-pocket maximums. The decision applies even when there is no generic alternative to a pricey, brand-name drug.

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7 questions about Covid-19 testing and what it means for reopening the country

Fri, 05/08/2020 - 11:36

Pressure to perform widespread Covid-19 testing is growing as public health experts and ordinary citizens question the safety of reopening schools and businesses across the U.S. without better information about who is infected and at risk of spreading the virus. That is only adding to the strain on the nation’s testing capacity, and raising questions about who should get priority.

The Infectious Diseases Society of America, which represents the nation’s infectious disease experts, issued guidelines Wednesday about who should be tested, how they should be tested, when they should be tested, and then what to make of the results. 

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Routine vaccinations for U.S. children have plummeted during the Covid-19 pandemic

Fri, 05/08/2020 - 10:00

Routine vaccination of children in the United States appeared to have declined dramatically in March and April, in the weeks after Covid-19 was declared a pandemic and the United States government declared a national emergency, a new study published Friday shows.

The authors, from the Centers for Disease Control and Prevention and other institutions, used vaccine ordering data from pediatricians who administer vaccines through the Vaccines for Children Program, which provides government-purchased vaccines to about half of the children in the United States. The study, published by the CDC in its Morbidity and Mortality Weekly Report, compared orders for the period from Jan. 7 through April 21 this year to the same period last year.

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What the world learned in eradicating smallpox: Unity mattered

Fri, 05/08/2020 - 08:26

Forty years ago, the world celebrated the vanquishing of a formidable foe, smallpox, which had maimed and killed millions for centuries. On May 8, 1980, the World Health Organization declared that smallpox had been eradicated.

That milestone, reached while the Cold War still raged, is an example of what the public health world can achieve when it works together — and is particularly resonant in the midst of the coronavirus pandemic. The campaign against smallpox took 21 years and required not just vaccinations but tracking and isolating new cases.

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STAT Plus: Pharmalittle: Hydroxychloroquine fails to help patients in a study; what will states do with the old malaria drug now?

Fri, 05/08/2020 - 06:17

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. The agenda is rather modest, though, since we may spend part of the time dreaming about the day when we can resume close encounters of the previous kind. For now, we plan to hang with the short person, pretend that we are training the official mascot, and take a few naps. And what about you? This is a good time to check your supply of masks or, perhaps, plan your grocery shopping. You could binge-watch something on the telly or reach out, so to speak, to older folks who are cooped up. Well, whatever you do, chin up. Keep on the sunny side and stay safe. See you soon. …

A study found that hydroxychloroquine, a decades-old malaria drug touted by President Trump, did not appear to help hospitalized patients with Covid-19, CNBC says. The observational study looked at 1,376 consecutive patients who arrived at the emergency room with symptoms of coronavirus. Nearly 60%, or 811 of the patients, received the drug within 48 hours and were found, on average, to be more severely ill than those not given the drug. The findings did not find any potential benefit or harm from the drug.

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