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From Houston to Miami, hospitals running short of remdesivir for Covid-19 patients

Fri, 07/10/2020 - 13:00

With Covid-19 patients filling her Houston hospital, pharmacist Katherine Perez wishes she had enough remdesivir to treat all those who might benefit.

In June, as Texas businesses welcomed customers and coronavirus cases surged, Houston Methodist, the hospital where she works, restricted the medication to only those patients who weren’t yet on ventilators, in the hope of making the supply last longer.

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STAT Plus: How can cancer drug prices better match their benefits? Germany offers a cost-saving model

Fri, 07/10/2020 - 12:22

After Germany revamped its approach to purchasing medicines a decade ago, the prices negotiated by the government for cancer treatments were more closely aligned with clinical benefits, a new study finds. Moreover, the effort led to a 25% drop in prices one year after product launches, prompting the researchers to suggest U.S. policymakers should consider Germany as a cost-saving model.

In reaching their conclusion, the researchers examined data for 57 cancer treatments that were launched in Germany from 2002 to 2017. Specifically, they compared incremental health benefits and costs of these treatments before and after the country enacted a law in 2011 which allowed drug makers to freely set prices for newly authorized medicines for one year before negotiations take place.

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In another Covid-19 disparity, Black and Hispanic Americans are dying at younger ages than white Americans

Fri, 07/10/2020 - 10:00

Long after calls for more data on the disproportionate number of Covid-19 infections and deaths among Black Americans and Hispanic Americans, the Centers for Disease Control and Prevention on Friday released limited additional information, which revealed non-white and Hispanic Americans under age 65 are dying in greater numbers than white people in that age group.

The agency reported that more than a third of deaths among Hispanic Americans (34.9%) and almost a third of deaths among non-white Americans (29.5%) were in people younger than 65. That compares to 13.2% among white people under that age. 

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

Fri, 07/10/2020 - 09:19

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 Akcea Therapeutics (AKCA) hired Tracy Palmer Berns as chief compliance officer. Previously, she worked at AMAG Pharmaceuticals (AMAG), where she was vice president, chief compliance officer and legal affairs.

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STAT Plus: As European Commission decision looms, Google faces continued scrutiny over Fitbit deal

Fri, 07/10/2020 - 07:25

Google is again facing questions from regulators about its $2.1 billion bid for Fitbit. The biggest sticking point: How will the tech giant use Fitbit’s trove of health data?

Google is staring down the possibility of a sweeping antitrust investigation launched by regulators in the European Union, which would become the latest in a series of probes into the deal. But the tech giant could sidestep that investigation by making a binding pledge not to use Fitbit’s health data for advertising purposes, Reuters reported this week. The deadline for Google to make such a concession is July 13. The European Commission, which is overseeing the probe, is scheduled to make a decision by July 20.

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STAT Plus: Pharmalittle: BioNTech expects to seek approval for vaccine by year-end; why the FDA chose a 50% threshold for Covid-19 vaccines

Fri, 07/10/2020 - 06:45

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. Our agenda, not surprisingly, is exceedingly modest. We plan to catch up on our reading, promenade with the official mascot, and check in on the Pharmalot ancestors. And what about you? This is a fine time to enjoy the great outdoors, tidy up around your castle, or touch base with those who may feel isolated. Well, whatever you do, have a grand time. But remember, be safe and wear a mask. Enjoy, and see you soon. …

BioNTech, which has partnered with Pfizer (PFE) to develop a Covid-19 vaccine, is confident it will be ready to seek regulatory approval by the end of the year, and several hundred million doses could be produced even before approval, and over 1 billion by the end of 2021, The Wall Street Journal writes. The vaccine BioNTech is developing uses experimental technology known as messenger RNA, or mRNA. Pending approval by authorities, BioNTech expects to begin the final stage of the testing process, known as Phase 3 trials, at the end of July.

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STAT Plus: Relay Therapeutics, focused on solid tumors, seeks to raise $250M in IPO

Fri, 07/10/2020 - 06:05

Relay Therapeutics, a Cambridge, Mass.-biotech focusing on cancer treatments, plans to raise $250 million when it goes public, amid strong recent stock market debuts by other biopharma startups.

The startup is developing treatments for solid tumors. In 2018, Relay’s chief executive, Dr. Sanjiv Patel, said the firm was harnessing breakthroughs in computer technology to make movies of proteins in motion. Malfunctioning proteins are implicated in many diseases, and the images would help scientists better design medicines that could bind to targets.

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Opinion: Patients should have a role in deciding the value of medicines

Fri, 07/10/2020 - 01:45

Policymakers increasingly consult value assessment models to help price new medical interventions. Value models use prespecified approaches and selected health outcomes to match the price of an intervention to its expected benefits. Who chooses the approach and outcomes, however, is at the center of a debate about the value of pharmaceutical, biotech, and medical device-based interventions.

Patients, their family members, and the general public have historically been excluded from contributing to value assessment models. We believe that their voices and views should be essential elements in measuring value.

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Opinion: Covid-19 should spark a reexamination of trade secrets’ stranglehold on information

Fri, 07/10/2020 - 01:40

As the world struggles to confront the Covid-19 pandemic, how to handle access to trade secrets — information that is valuable because others do not know it — is one of the myriad challenges to achieving safe and effective vaccines, diagnostics, and treatments for the people of the world.

The most famous trade secret is the Coca-Cola formula. If someone accessed that formula who wasn’t supposed to, a misappropriation lawsuit from Coca-Cola would soon follow. While a scenario like that may seem foreign to the Covid-19 pandemic, trade secrecy spans a shockingly broad range of critical and lifesaving information.

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STAT Plus: A new tool aims to help patients sort through 200 mental health apps — and counting

Fri, 07/10/2020 - 01:35

There are nearly 20,000 mental health apps that will do everything from tracking a person’s suicidal thoughts to soothing someone experiencing a panic attack. A new online tool from researchers at Beth Israel Deaconess Medical Center aims to help patients sort through the noise for almost 200 of them — and counting.

Using the tool — which still lacks the pithy names that are otherwise common in the tech world — patients can sort the apps by whether they’ll have to pay for it, the kinds of services it offers, like mood tracking or journaling, the intensity of its privacy policy, and the clinical evidence that supports it. That last point is critical, since so many apps fail to provide high-quality research to back up their scientific claims.

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‘I feel like I am not welcome’: Medical, doctoral students from abroad grapple with uncertainty from new ICE rules

Fri, 07/10/2020 - 01:30

International students completing their medical and doctoral degrees in the United States are wrestling with frustration and uncertainty following the release of federal rules this week that could bar them from staying in the country.

In an emergency ruling Monday, U.S. Immigration and Customs Enforcement said that students who are on an F-1 visa — usually reserved for international students enrolled in degree programs in the U.S. — will have to leave the country if their schools have opted for online-only classes in the fall. The rules also apply to students who are here on an M-1 visa, which is for completing vocational training and other technical courses.

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STAT Plus: Despite the pandemic, prices for many drugs keep rising

Thu, 07/09/2020 - 12:58

Despite the economic hardships the Covid-19 pandemic has created for many Americans, drug makers raised list prices on 42 brand-name medicines by an average of 3.5% this month, surpassing the number of price hikes taken by the pharmaceutical industry at this time a year ago.

The price increases added to the average 6.8% price hikes that companies took on 857 brand-name and generic drugs between January and June, according to data compiled by GoodRx, which tracks prescription drug pricing and provides free coupons for discounts on medications. Drug makers generally raise prices twice a year: in January and in July.

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Listen: Trump’s FDA pressure, a microcosm of the pandemic, and squabbling over a vaccine

Thu, 07/09/2020 - 12:28

Who will stand up to the White House? How can hospitals protect workers from Covid-19? And what ever happened with Biogen?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, STAT Washington correspondent Nicholas Florko joins us to explain how mounting pressure from President Trump is affecting the Food and Drug Administration and the Centers for Disease Control and Prevention. Then, our colleague Eric Boodman calls in to talk about his latest story: a moving piece about a Boston hospital kitchen worker who died from Covid-19. Finally, we embark on a lightning round, featuring Biogen’s long-delayed treatment for Alzheimer’s disease and the internecine drama behind a leading coronavirus vaccine candidate.

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STAT Plus: How does exercise benefit the aging brain? Transfusing blood from active mice into sedentary ones suggests an answer

Thu, 07/09/2020 - 11:00

Exercise has been shown to slow cognitive decline in aging, but scientists haven’t known why. Now, by transfusing blood from exercising mice into sedentary ones, researchers have found a single protein, produced in the liver, that seems to underlie restorative effects in the brain.

The discovery is the latest to emerge from scientists’ hot pursuit of treatments to forestall aging, or at least prolong a healthy life span. Previous research on transfusions of “young blood” — plasma from younger blood donors — has captured the public’s imagination, spurring rumors of self-experimentation by aging Silicon Valley entrepreneurs and a government warning last year that such infusions provide no proven health benefit for older adults. The new research suggests it’s not the youthfulness of the blood donor, but their activity level, that might confer a cognitive benefit.

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STAT Plus: Two dozen big drug makers launch a $1 billion fund to develop new antibiotics

Thu, 07/09/2020 - 09:55

In response to heightened concerns over antibiotic resistance, two dozen of the world’s largest pharmaceutical companies have formally launched a $1 billion for-profit venture fund to replenish the global medicine chest with novel treatments.

The new Antimicrobial Action Fund will look to buy or invest in small antibiotic companies and their products, and will work with the World Health Organization and the European Investment Bank to identify promising prospects. The fund is expected to start operations by the end of the year and hopes to bring to market at least two to four novel antibiotics by 2030.

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WHO launches independent review of the international response to the Covid-19 pandemic

Thu, 07/09/2020 - 08:14

The World Health Organization announced an independent review of the international response to the Covid-19 pandemic on Thursday, an action the organization’s member states tasked it with earlier this year.

Former Liberian President Ellen Johnson Sirleaf, a Nobel Peace Prize winner, and Helen Clark, former prime minister of New Zealand, will lead the review, the WHO director-general, Tedros Adhanom Ghebreyesus, announced in Geneva.

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STAT Plus: Pharmalittle: Gilead to boost remdesivir supplies in Europe; drug makers announcing $1 billion antibiotic innovation fund

Thu, 07/09/2020 - 06:24

Good morning, everyone, and welcome to another busy day. You made it this far this week, so why not continue, yes? While you ponder the possibilities, we will celebrate a gorgeous morning with some needed cups of stimulation. After the heat and humidity of the past few days, a sparkling sun and coooool breeze are quite welcome. And of course, we are happy to pass along the latest menu of tidbits to get you started on your way. Hope you have a smashing day, and do stay in touch. We accept documents and tips. …

Gilead Sciences (GILD) plans to make more of its experimental remdesivir treatment available for Europe as of this coming autumn and will decide how much each country gets based on the rate of infection, Reuters writes. Bettina Bauer, managing director of Gilead in Germany, told WirtschaftsWoche that the company can increase its worldwide monthly production from currently 190,000 treatment cycles to 2 million treatment cycles in December. Bauer said she was in talks with the German government about increasing supply.

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The first round of Covid-19 vaccines is ‘highly unlikely to be a magic bullet,’ Medicago CEO says

Thu, 07/09/2020 - 04:49

Earlier this week, a Canadian company called Medicago struck two deals to supply its plant-based technology to other companies in hopes of developing a Covid-19 vaccine. The agreements with GlaxoSmithKline (GSK) and Dynavax (DVAX) drew attention to a company that, although partly owned by Philip Morris International, has had a relatively low profile, despite its novel approach. The privately held entity uses a virus-like particle, or VLP, grown in a close relative of the tobacco plant to produce one of the three spike proteins found in Covid-19. The plan is to marry its VLP to an adjuvant, with the goal of providing vaccine doses to the greatest number of people. We spoke with Medicago chief executive Bruce Clark about its approach, as well as the challenges in finding a vaccine to combat Covid-19 and satisfying global demand. This is an edited version of our conversation…

So this is a big step. What brought you to this point?

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Opinion: It’s time to begin a national wastewater testing program for Covid-19

Thu, 07/09/2020 - 01:45

As the Covid-19 pandemic marches across America, causing record-breaking numbers of cases, almost every solution for controlling the disease includes more testing, especially as cities and states try to reopen. But with states hitting their limits on testing, we need new tools for understanding Covid-19 transmission. A national wastewater surveillance program offers a cost-effective approach to track Covid-19 across the majority of the U.S. population and provide early warnings of resurgence.

Simply testing individuals with symptoms won’t be enough to track how many people are infected. Given the high degree of asymptomatic spread — even in the absence of superspreading events — we need a national strategy that relies heavily on surveillance. Experts increasingly argue that we should be testing nursing home residents every week. Some universities are planning to test every student multiple times per week. And the federal government is talking about pooled testing as a strategy for testing large groups of individuals at once. The hope is that such testing, when coupled with robust contact tracing, can identify infections before they spread.

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Opinion: To thrive, Black and Latinx physicians need their communities

Thu, 07/09/2020 - 01:40

I was working at the nurses’ station in the emergency department when the elderly man in Room Four smiled at me.

I had noticed him watching me sometime between my third and seventh trip to the department. It was near the end of a long day about halfway through my neurology training, and I’d spent it crisscrossing the hospital to see a multitude of patients, sprinting from one stroke code to the next and responding to the ceaseless buzz of my pager.

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