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Reporting from the frontiers of health and medicine
Updated: 1 hour 22 min ago

Opinion: What the biopharma industry is doing to build confidence in Covid-19 vaccines

2 hours 6 min ago

Over the last few weeks, the United States has surpassed 100,000 Covid-19 cases a day and reached the staggering milestone of 10 million cases. This is both sobering and humbling.

While there has been encouraging news about progress in the development of Covid-19 vaccines, making sure that Americans have confidence in these vaccines is crucial to helping bend the curve of infections and getting us back to some semblance of normalcy.

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Opinion: Beyond burnout: For health care workers, this surge of Covid-19 is bringing burnover

2 hours 11 min ago

Covid-19 is roaring back for a third wave. The first two substantially increased feelings of moral injury and burnout among health care workers. This one is bringing burnover.

Health care systems are scrambling anew. The crises of ICU beds at capacity, shortages of personal protective equipment, emergency rooms turning away ambulances, and staff shortages are happening this time not in isolated hot spots but in almost every state. Clinicians again face work that is risky, heart-rending, physically exhausting, and demoralizing, all the elements of burnout. They have seen this before and are intensely frustrated it is happening again.

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STAT+: ‘The trend is irreversible’: How Covid-19 could drive a shift toward decentralized trials

2 hours 16 min ago

Covid-19 started as a disaster for clinical research, halting or delaying 3 of every 4 trials worldwide. But in the months since, it has also become a showcase for decentralized research that uses telemedicine and mobile technologies to accelerate the pace of discovery — and potentially cut its costs.

Clinical investigators have been forced to modernize their approaches out of necessity, incorporating digital tools to help recruit participants, monitor them remotely, and analyze data using artificial intelligence.

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A ‘bad case of déjà vu’: New Jersey hospitals brace for Covid-19 surge, but hope this time will be different

2 hours 21 min ago

The first round of treating Covid-19 patients in New Jersey was brutal. Victorine Long Njaka, a nurse at Trinitas Regional Medical Center in Elizabeth, can’t shake the memory of a 34-year-old patient from last spring. He could barely breathe, and was so weakened by the virus, he seemed to have lost his will to live.

Long Njaka, 37, couldn’t bear more deaths of people her age. Her brain was overloaded with the constant calls over the hospital intercom for coronavirus patients in respiratory or cardiac arrest — “Code Blue 19” — and with all the bodies she had escorted to the morgue.

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STAT+: Alnylam wins FDA approval for first drug to treat rare kidney disease

Tue, 11/24/2020 - 11:58

Alnylam Pharmaceuticals Inc. scored its third approval from the US Food and Drug Administration in as many years Monday, this time for a medicine to treat a rare disease that affects the kidneys.

The rare disorder — called primary hyperoxaluria type 1 — causes a buildup of oxalate in the body, which when not filtered properly can cause kidney and bladder stones.

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STAT+: Which pricey drugs will Trump’s international pricing policy target?

Tue, 11/24/2020 - 11:21

A version of this story first appeared in D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.

WASHINGTON — President Trump’s new drug pricing policy, to tie certain U.S. drug prices to those in other countries, will cost a small cadre of drug makers millions, if not billions.

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STAT+: Pharmalittle: EU plots a crackdown on delay of generic drugs; Russia says its Covid-19 vaccine is 95% effective

Tue, 11/24/2020 - 06:01

Good morning, one and all. Damian Garde here, filling in for Ed Silverman in the waning work hours before the big holiday. Whether you’ve chosen to visit loved ones or observe in isolation, we’d advise you to keep your decision out of the paper of record. In the meantime, here are your requisite tidbits to get the day started. As always, if you hear something interesting out there, do let us know.

The European Union is planning a sweeping change in its rules governing generic drugs, Reuters reports, a move that could cut into the bottom lines of global pharmaceutical firms. The draft law, which could take effect in 2022, would crack down on firms that delay the approval of generics, limit patent protection for companies that don’t make their products available in all 27 member states, and aim to prevent drug shortages across the EU.

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Opinion: OSHA’s ‘absurd reinterpretation’ of a regulation regarding workers and Covid-19

Tue, 11/24/2020 - 01:40

Workplace exposures continue to be a major driver of the coronavirus pandemic, something that the Occupational Safety and Health Administration (OSHA) should be on top of. But a reinterpretation of a reporting rule is making that all but impossible.

The workers who take care of our sick and elderly, who keep our families fed and provisioned, and who keep our transportation systems operating do their jobs at great risk of illness and death. Those jobs put them in close contact with other workers and the public, and they are often given inadequate personal protective equipment — or none at all. Many travel to and from work in crowded public or semi-private transportation. Since the virus does not stop at the exit of the factory or nursing home or prison or subway car, these workers bring the epidemic into their homes and communities.

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Opinion: Now is the time to innovate for more than 1 billion people with neglected tropical diseases

Tue, 11/24/2020 - 01:35

With the first results of multiple Covid-19 vaccine candidates giving hope to billions of people around the world, the power of biomedical research has captured the public’s attention. The speed with which it moved to develop vaccines, treatments, and diagnostic tests has been impressive — although equitable access to these innovations is still unsure.

The same kinds of efforts should be deployed for the more than 1 billion people living with so-called neglected tropical diseases.

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As a kid, his factory work paid for his dad’s cancer care. As an oncologist, his research offers more than survival

Tue, 11/24/2020 - 01:30

No one knows when, exactly, Mutlay Sayan was born. His mother told him it was sometime in the summer, before the harvest. The delivery took place on their porch, with the help of the neighbors, who used a heated kitchen knife to cut the umbilical cord, in a year that may or may not have been 1987. Eventually, someone invented a birthday for him, to satisfy the needs of official documents, just as he would fill in all sorts of other gaps — a real-life David Copperfield who went from little kid in his parents’ fields to child factory worker in Istanbul to radiation oncologist in New Jersey.

He grew up at the eastern-most tip of Turkey, which pokes like a nose into Armenia and Iran — and when describing his childhood, he often starts with everything it didn’t have. There was no electricity or running water. He’d never seen a car or a television. He didn’t go to school, so he didn’t know what a weekend was, and never learned to read. The memories feel recent to him, warm and vivid, but they’re tinged with a time-warped strangeness. “It feels like centuries ago,” he said.

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‘Essential workers’ likely to get earlier access to Covid-19 vaccine

Mon, 11/23/2020 - 16:29

Essential workers are likely to move ahead of adults 65 and older and people with high-risk medical conditions when the Centers for Disease Control and Prevention signs off on Covid-19 vaccine priority lists, coming after health care workers and people living in long-term care facilities, a meeting of an expert advisory panel made clear Monday.

The intention is to bring many people of color closer to the front of the vaccine priority line — should they want to be vaccinated — in recognition of the fact that the pandemic has disproportionately hit Black and Latino communities.

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Opinion: CMS’s new rules on organ donation and transplantation ‘will bring chaos’

Mon, 11/23/2020 - 08:24

The United States had a once-in-a-generation opportunity to save countless additional lives each year by enacting smart reform of the federal regulations that govern organ donation and transplantation. Unfortunately, final federal regulations the Trump administration published late Friday squandered that opportunity.

As the Centers for Medicare and Medicaid Services was undertaking a revision of its operational rules and corresponding metrics, U.S. donation and transplant professionals urged it to realign last-century methods now used by key components of the organ donation and transplant system with 21st-century innovations.

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STAT+: A new startup wants to use natural killer cells to fight cancer

Mon, 11/23/2020 - 07:08

On a blustery day last December, five biotech entrepreneurs and scientists walked past the snow-draped Boston Common and entered Yvonne’s, the cozy supper club and bar, to discuss a new potential biotechnology company to fight cancer.

There, over libations poured at a mahogany bar, they talked about the recent success of groundbreaking drugs that harness the immune system to combat cancers of the blood. Could they do something similar to treat solid tumors, which are far more common? Could they use “natural killer” cells, a potent immunological weapon that can be harvested from healthy people? If so, what would be the best approach?

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STAT+: Pharmalittle: AstraZeneca says its vaccine cuts Covid-19 risk by 70%; U.S. shots will ‘hopefully’ start within three weeks

Mon, 11/23/2020 - 05:51

Good morning. I’m Elizabeth Cooney, filling in for Ed Silverman today as he prepares to give thanks. Only French roast coffee and feline mascots to tell you about while we greet a holiday-shortened work week on this side of the pond. Here are some news items to get us going:

AstraZeneca (AZN) said Monday that its coronavirus vaccine reduced the risk of Covid-19 infection by an average of 70.4%, according to an interim analysis of large Phase 3 trials conducted in the United Kingdom and Brazil, STAT reports. The AstraZeneca vaccine, developed in partnership with Oxford University, is the third vaccine to announce positive clinical trial results this month. Two other vaccine candidates, one from partners Pfizer and BioNTech and the other from Moderna, showed 95% efficacy against Covid-19 infections in their respective clinical trials.

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STAT+: Merck to pay $425M for biotech to get Covid-19 drug, but says manufacturing will be a challenge

Mon, 11/23/2020 - 03:45

The drug giant Merck said Monday it would purchase Rockville, Md.-based OncoImmune for $425 million in cash to obtain the company’s treatment for patients hospitalized with severe and critical Covid-19. 

In an interview with STAT, Merck’s head of research and development, Roger Perlmutter, said that clinical trials for the treatment, CD24Fc, were encouraging but that manufacturing could prove a challenge. Still, he said, he hopes that, if proven safe and effective, it will be possible to make the medicine in useful quantities in the first half of 2021.

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STAT+: Raging at the pandemic, a VC raises $800M for a company that aims to transform biotech manufacturing

Mon, 11/23/2020 - 03:30

In March, as waves of Covid-19 cases began surging across the U.S., biotech venture capitalist Robert Nelsen was “pissed off” about his prescient fear that new biotech treatments, even if they emerged, would not be able to be manufactured in sufficient amounts.

As usual, Nelsen’s rage resulted in a new company: Resilience, backed by $800 million from Nelsen’s ARCH Venture Partners, 8VC, and other sources, and aimed at transforming manufacturing. The company’s board includes a who’s who of former industry and government officials. 

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AstraZeneca Covid-19 vaccine is 70% effective on average, early data show

Mon, 11/23/2020 - 03:12

AstraZeneca said Monday that its coronavirus vaccine reduced the risk of Covid-19 infection by an average of 70.4%, according to an interim analysis of large Phase 3 trials conducted in the United Kingdom and Brazil.

The AstraZeneca vaccine, developed in partnership with Oxford University, is the third vaccine to announce positive clinical trial results this month. Two vaccine candidates, one from partners Pfizer and BioNTech and the other from Moderna, showed 95% efficacy against Covid-19 infections in their respective clinical trials.

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Opinion: Make list price the touchstone for drug pricing across the supply chain

Mon, 11/23/2020 - 01:50

In October, the House Oversight Committee turned a magnifying glass on the rising cost of prescription drugs. With health care costs critical to voters on both sides of the aisle, lawmakers grilled drug company executives on practices from copay assistance to evergreening. Rep. Katie Porter (D-Cal.) and her whiteboard garnered viral attention after she interrogated Celgene CEO Mark Alles about price hikes to the cancer drug Revlimid.

And the White House recently stepped into the fray. A broad administration rule issued on Oct. 29 will require insurance companies to tell their customers in advance what their out-of-pocket cost will be for a drug and what the company actually paid for it. The rule applies only to private insurance, rather than Medicare and Medicaid, and it is likely to be bogged down quickly in litigation over issues such as proper rule-making procedures, freedom of speech, and trade secrets, but it represents a major attempt at providing information to patients.

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Opinion: Glaring omission from Biden’s Covid-19 task force: mental health expertise

Mon, 11/23/2020 - 01:45

The unprecedented spike in depression and anxiety that has accompanied the coronavirus pandemic points to a glaring omission from President-elect Biden’s Covid-19 task force: Mental health expertise is nowhere to be found among the physicians, epidemiologists, and public health experts.

Pandemic-related depression and anxiety are disproportionately affecting young people. While young adults have generally not been hard hit physically by Covid-19, the pandemic has had profound consequences for their day-to-day lives and their mental health. There is a pressing need for the federal government and individual institutions like universities and community colleges to address the challenges young adults face during — and after — Covid-19. The place to start is by including mental health expertise on the coronavirus advisory panel and ensuring investment in mental health access.

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Data show hospitalized Covid-19 patients are surviving at higher rates, but surge in cases could roll back gains

Mon, 11/23/2020 - 01:30

Patients hospitalized with Covid-19 are surviving at higher rates than in the early days of the pandemic, gains that data and interviews with experts suggest are driven by a more refined understanding of the disease and how to treat it — and, crucially, less strain on hospitals that had been inundated at times.

Other factors have contributed to the improved outcomes: Steroids that help save some lives are being used more widely, and people infected after the initial surge were, as a whole, younger and arrived at the hospital earlier in the course of the disease.

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