2024

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STAT+: How UnitedHealth harnesses its physician empire to squeeze profits out of patients

STAT

UnitedHealth Group started out as a small, Minnesota health insurance company and has since morphed into a modern-day Standard Oil, exerting unmatched dominance over health care in the United States. It’s no secret that UnitedHealth is a colossus: It’s the country’s largest health insurer and the fourth-largest company of any type by revenue, just behind Apple.

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

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COVID-19 vaccinations now ‘alarmingly low’ in Europe

pharmaphorum

COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Study suggests targeting amyloid beta production could be promising in AD

Pharma Times

The neurodegenerative disease is currently the most common cause of dementia

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DEA Proposed Rule Seeks to Reclassify Marijuana

Pharmacy Times

Pharmacists could play a major role in answering patient questions and providing counseling about cannabis

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STAT+: Jeff Shuren, medical devices head at FDA, to leave the agency

STAT

Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration, announced to staff on Tuesday that he is leaving the agency, according to six sources and an email reviewed by STAT. Shuren, who spent 28 years at the agency, started his FDA career in the Commissioner’s Office in 1998. He became director of the Center for Devices and Radiological Health in 2009 and has served in that position ever since.

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Bird flu that infected 6 Colorado poultry workers is closely related to the virus in cows

STAT

Bird flu snapshot: This is the latest installment in a series of regular updates on H5N1 avian flu that STAT is publishing on Monday mornings. To read future updates, you can also subscribe to STAT’s Morning Rounds newsletter. Public health experts who’ve been following the surprising spillover of H5N1 bird flu into America’s dairy cattle herds now have all eyes on Colorado, waiting to see if a cluster of human cases there might balloon into something bigger.

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Opinion: An aging geriatrician wonders: Who will care for me?

STAT

In 1988, I became one of the first U.S. physicians certified in the new specialty of geriatric medicine, which focuses on the health care of older adults. As an idealistic and optimistic 32-year-old geriatrician, I believed that this branch of medicine would undoubtedly emerge as a vibrant field of medicine, benefiting patients and society. I was also confident that when I reached older adulthood, the health care system would be ready to care for me.

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Opinion: To get a fair deal on Wegovy, buying Novo Nordisk might not be Medicare’s worst option

STAT

Medicare and Medicaid are facing a familiar quandary: how to provide coverage for new weight loss drugs with price tags that could effectively bankrupt the federal government’s health care budget while simultaneously ensuring continuous coverage for all other health care services used by millions of Americans. The Centers for Medicare and Medicaid Services announced in March 2024 that it would cover Wegovy (semaglutide), a new and expensive weight loss medication, for beneficiaries with c

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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STAT+: A pricey Gilead HIV drug could be made for dramatically less than the company claims, researchers say

STAT

Following the release of widely touted study results for a Gilead Sciences HIV treatment, a new analysis finds the medicine — called lenacapavir — could be made for as little as $26 to $40 per person each year, which the researchers argue could alleviate concerns about limited access in many countries. The medicine drew considerable attention last month after a late-stage clinical trial found that twice-a-year injections completely protected cisgender women from contracting HIV.

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Kamala Harris, endorsed by Biden to replace him, is left of the president on health care

STAT

WASHINGTON — President Biden is ending his bid for a second term in office and backing Vice President Kamala Harris to take the nomination, he announced Sunday. While Harris shares similar views as Biden on many issues, she is to the left of the president on health care. “I believe it is in the best interest of my party and the country for me to stand down and focus solely on fulfilling my duties as president for the remainder of my term,” the president wrote in a letter sha

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STAT+: Jiankui He, creator of CRISPR-edited children, relocates to a Chinese medical tourism hub

STAT

Jiankui He, the Chinese scientist who s parked a global uproar in 2018 when he revealed he had created the first gene-edited children , is again out on his own after being dismissed from an academic post. In January 2019, provincial health authorities found that He’s human CRISPR experiments violated national regulations against gene-editing for reproductive purposes.

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Q&A: Trans adults face ‘shocking’ risk of cirrhosis, especially alcohol-driven

STAT

People under 45 have been driving an increase in liver-related deaths, especially those caused by alcohol. But a sliver of that young adult population is being hit disproportionately hard by alcohol-associated liver disease: transgender people. Although trans adults make up less than 1% of the United States population, a study published in The American Journal of Gastroenterology last month shows they face double the risk of severe liver disease, and a higher share of cirrhosis from heavy drinki

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Microsoft global outage forces health systems to cancel appointments, delay procedures

STAT

On Thursday, a widespread outage to Microsoft systems took down computers in health systems around the globe, leading many to cancel non-urgent medical appointments and surgeries as they encouraged patients to make plans for disrupted travel and delays in care. “A major worldwide software outage has affected many of our systems at Mass General Brigham,” the hospital system shared in a statement on Friday.

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At a Mass General perfusion lab, a push to make more and more hearts viable for transplant

STAT

It seems like organized chaos. Five lab members move around a room the size of a galley kitchen. On this day, three high school students also squeeze into the medical lab, closely peering at a pig heart barely beating in a box. Tubes connected to the heart from a rhythmic, speaker-like pump push warm red blood cells through its chambers. It looks like a scene out of Frankenstein.

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Wastewater surveillance group funded by Google founder, Bloomberg sheds dozens of testing sites

STAT

WastewaterSCAN, one of the United States’ largest private entities that provide real-time data on pathogens in wastewater, has stopped collecting data from 43 facilities due to “resource constraints,” according to emails the company sent to staff overseeing these sites. The group — based at Stanford University, in partnership with Emory University — had been collecting samples from 194 sites in 41 states and the District of Columbia, a swath including 39 millio

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Vaccination slashes risk of long Covid, says large study tracing cases through Delta and Omicron variants

STAT

Vaccination lowers the chance of developing long Covid, according to a large new study that also found that the risk of serious complications has diminished but not disappeared as new coronavirus variants emerged. The study, published Wednesday in the New England Journal of Medicine , compared the health records of more than 440,000 Veterans Affairs patients who were infected with Covid-19 with records of more than 4 million uninfected people.

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As GLP-1 sales surge, insulin users fear Novo Nordisk and Eli Lilly will move on without them

STAT

Around the world, patients suddenly can’t find enough of the insulins made by companies they have long relied on to do so. In the U.S., Novo Nordisk’s recent decision to discontinue a product has left patients with fewer options. At the same time, patients are encountering shortages of other products from Novo and Eli Lilly. For months, pharmacies have been running out of vials of certain insulins that patients use to fill the pumps they wear on their body.

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Opinion: The ‘Risky Research Review Act’ would do more harm than good

STAT

In an era of rapid scientific and technological advances when politicians and scientists are struggling to find the right balance between innovation and safety, Sen. Rand Paul (R-Ky.) has introduced the Risky Research Review Act (S. 4667) in an effort to navigate this treacherous terrain. But instead of providing clarity and security, this legislation threatens to cast a shadow over the future of life sciences research and slow it down.

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STAT+: Viking accelerates development of obesity drug that could rival Wegovy, Zepbound

STAT

Viking Therapeutics plans to move its injectable obesity treatment into a Phase 3 study faster than expected, bringing the biotech closer to joining the highly competitive GLP-1 drug market.  The San Diego-based biotech previously said it was anticipating to start a Phase 2b trial of the therapy, VK2735, after getting positive results from a Phase 2 study.

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At an Iowa county fair, a tradition carries on despite bird flu anxiety in the dairy barn

STAT

DECORAH, Iowa — It was livestock check-in day at the Winneshiek County Fair, and the dairy barn was consumed with a kind of pre-prom anxiety. A cow named Daiquiri was lumbering back from the milking parlor, adjusting to a new schedule that would have her “mammary system” bulging for showtime. Kennedy was getting a fresh shave, tufts of udder-fuzz drifting to the floor, revealing her resplendent venation.

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USDA maintains bird flu can be eliminated from dairy cows, even as doubts mount among experts

STAT

Facing increasing doubts that the U.S. can control the outbreak of avian influenza among dairy cattle, federal officials reiterated on Tuesday that they believe the country can still eliminate the H5N1 virus from dairy cows, even as it continues to spread to new herds. “All the signs that we have are, with good biosecurity, with good farmer participation, we will be able to eliminate this,” Eric Deeble, the acting senior adviser for the H5N1 response at the U.S.

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Opinion: Why aren’t philanthropists stepping up to support nursing education?

STAT

Michael Bloomberg’s donation of $1 billion to Johns Hopkins University to support medical education goes beyond similar gifts to other medical schools. The Bloomberg gift provides support to students in Hopkins’ schools of nursing and public health, not just in its medical school. As health professionals and educators, we are thrilled to see philanthropists supporting the future of medical training in the U.S.

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Bird flu snapshot: As the number of infected dairy herds mount, so too does pessimism about driving H5N1 out of cows

STAT

Bird flu snapshot: This is the latest installment in a series of regular updates on the H5N1 flu outbreak in dairy cows that STAT is publishing on Monday mornings. To read future updates, you can also subscribe to STAT’s Morning Rounds newsletter. There are more human cases of H5N1 bird flu infection, and another state has joined the list of those with infected dairy cow herds.

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Hospitals, labs, and health departments try to cope with blood culture bottle shortage

STAT

Hospitals across the country are facing a severe shortage of supplies of blood culture bottles, critical tools for diagnosing serious and sometimes life-threatening bloodstream infections. The Centers for Disease Control and Prevention sent out an alert Tuesday to health care providers, laboratory professionals, health care facility administrators, and state, tribal, local, and territorial health departments warning of the shortage of Bactec blood culture medium bottles, marketed by Becton Dicki

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Long Covid is more prevalent among Americans with disabilities, new CDC data show

STAT

The Centers for Disease Control and Prevention just released a trove of data on Americans with disabilities that found that more than a quarter of U.S. adults have a disability — over 70 million people, a bump from prior years. This slice of the population was also much more likely to report long Covid symptoms such as chronic fatigue and brain fog.

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Key disability civil rights law will get a big refresh under Sen. Bob Casey’s new bill

STAT

A key piece of disability civil rights law could get a much-needed refresh. Sen. Bob Casey Jr. (D-Pa.) will introduce legislation Wednesday to strengthen and extend Section 508 of the Rehabilitation Act of 1973. The proposed update would boost online accessibility for people with disabilities on federal websites and significantly expand protections and working conditions for disabled federal employees.

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STAT+: Top FDA officials weighing regulation of ultra-processed foods, internal documents show

STAT

WASHINGTON – Top Food and Drug Administration officials met multiple times earlier this year to discuss the regulation of ultra-processed foods, according to internal agency calendars obtained by STAT. Two FDA officials, Haider Warraich and Robin McKinnon, met multiple times in February to discuss regulating these edible industrial creations, such as sodas, prepackaged cookies, and most breakfast cereals.

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Alcohol is driving a half-dozen types of cancer in the U.S., study finds

STAT

Alcohol has long been classified as a cancer-causing substance, but a study out Thursday gives a clearer sense of just how many cancer cases and deaths may be driven by drinking.  Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, vi

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Opinion: Doctors ‘overprescribing’ opioids isn’t the cause of the overdose epidemic — and it never was

STAT

A key part of the federal government’s narrative about the epidemic of addiction and overdose deaths in the U.S. has been that it is driven by doctors and other clinicians overprescribing opioid painkillers. That story line is false — and was never true. The Centers for Disease Control and Prevention has traditionally relied on death certificate data compiled by the National Center for Health Statistics for its data on overdose deaths, organized as Underlying Cause of Death data us

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Opinion: Preparing schools for the H5N1 bird flu they’re likely to face

STAT

As Covid-19 swept across the United States, schools were among the most highly affected public spaces. To prepare for a potential H5N1 avian influenza jump to humans, schools need to be preparing for the scenario now before a sustained transmission event occurs. The response to Covid-19, which first appeared in the U.S. in early 2020, has been scrutinized by numerous case studies, after-action reports , and Congressional fact-finding hearings.

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Medicaid is paying millions for salty, fat-laden ‘medically tailored’ cheeseburgers and sandwiches

STAT

WASHINGTON – They’re marketed as healthy, “dietitian-approved” meals and delivered directly to the homes of people seriously ill from cancer, diabetes, or heart disease: a Jimmy Dean frozen sausage breakfast sandwich, biscuits and gravy, a cheeseburger. These are among the offerings sold by an Idaho-based company, Homestyle Direct, which is paid millions of dollars each year by taxpayer-funded state Medicaid programs to deliver what the company calls medically tailore

Diabetes 363
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Elmo and his friends are helping little kids (and grown-ups) with their ‘big feelings’ amid a mental health crisis

STAT

WASHINGTON — When Elmo asked “How is everybody doing?” back in January, he was not expecting the onslaught of stress, despair, and anxiety that hit his replies. “I’m just looking for somebody to talk to and show me some love if you know what I mean,” famous singer T-Pain wrote back to the red Muppet.

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