October, 2023

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Expert: Celebrating Pharmacists’ Role in Health Care, How the Profession Has Changed

Pharmacy Times

The assistant program director at Mayo Clinic discusses the significance of pharmacists’ role in health care, changes throughout the industry, and her passion for mentoring pharmaceutical students.

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Patient groups have become a powerhouse in R&D. Here’s a look at their impact.

PharmaVoice

“They have the money,” and they’re using it to influence drug development, according to the executive director of the IQVIA Institute for Human Data Science.

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Second recipient of genetically modified pig heart dies, six weeks after surgery

STAT

Nearly six weeks after his surgery, the world’s second recipient of a genetically modified pig heart has died, the University of Maryland announced Tuesday. Lawrence Faucette, a 58-year-old resident of Frederick, Md., with terminal heart disease, died Monday. He had received the experimental xenotransplant on September 20 at the University of Maryland Medical Center in an eight-hour operation.

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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

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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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Lawmakers mull lifting ban on physician-owned hospitals as doc lobbying groups claim major cost savings

Fierce Healthcare

A new analysis backed by doctor lobbying groups suggest that physician-owned hospitals could have fueled about $1.1 billion in savings across 20 of Medicare’s most expensive conditions in 2019— tho | Lobbying groups in favor of overturning the ban on new physician-owned hospitals outlined broad cost savings if 2019's Medicare patients were treated at such facilities instead of a traditional hospital.

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Forces for good

Drug Store News

Sheryl Burke, SVP of Corporate Social Responsibility & Chief Sustainability Officer of CVS Health, shines a light on the retailer's efforts to help communities at the local and national levels.

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Actor and epilepsy advocate Greg Grunberg wants the world to ‘talk about it’

PharmaVoice

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

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Extreme heat could lead to 233% increase in U.S. excess cardiovascular deaths, study says

STAT

When the human body is exposed to extreme heat, it tries to fight back. To keep us from cooking, our hearts pump faster and harder to distribute the hot blood out to our fingers and toes, away from precious internal organs. We produce more sweat, and when it evaporates, the blood beneath the skin’s surface cools down, helping to lower our body temperature.

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UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive

Fierce Pharma

Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.

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Medical AI scribe startup Nabla rolling out tool to Kaiser Permanente docs in Northern California

Fierce Healthcare

Nabla, maker of an autonomous clinical AI scribe, has joined forces with Kaiser Permanente to roll out its tool to 10,000 doctors in Northern California. | The AI tool will be available to 10,000 Kaiser Permanente doctors in Northern California across all care settings and specialties.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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Artificial Intelligence Helps Simplify Managed Care Pharmacy Workflow, Processes

Pharmacy Times

Artificial intelligence and machine learning can significantly benefit managed care pharmacy, specifically in contract reading and interpretation.

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The ALS therapy keeping the human pig heart transplant pumping

PharmaVoice

Eledon’s investigational ALS drug tegoprubart could also help prevent organ transplant rejections, the company says.

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STAT+: Tracking the FDA advisory panel on the first CRISPR-based treatment for sickle cell disease

STAT

The Food and Drug Administration is convening a meeting of outside experts on Tuesday to review exa-cel, a CRISPR-based treatment for sickle cell disease made by Vertex Pharmaceuticals and CRISPR Therapeutics. Tuesday’s meeting is set up a bit differently than most FDA advisory panels. The agency has not raised any concerns about exa-cel’s efficacy or safety, and there will not be a typical vote at the end of the day on whether the data from exa-cel’s pivotal clinical trial

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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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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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Industry Voices—The beginning of the end for Alzheimer’s Dementia?

Fierce Healthcare

The approval of Leqembi by the Food and Drug Administration marks an exciting turning point for Alzheimer’s disease. | The approval of Leqembi by the FDA marks an exciting turning point for Alzheimer’s disease. There are big questions around costs, access, risk and efficacy in certain populations. The most urgent, overarching question is: How can we find patients who will benefit from the drug before their condition progresses outside of the treatment window?

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AI in wound: Delivering advanced care through a national wound registry

pharmaphorum

AI in wound: Delivering advanced care through a national wound registry Mike.

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Physical Health, Mental Health Associated With Insomnia in Veterans

Pharmacy Times

Study finds that probable insomnia disorder was associated with physical health problems and difficulty with anger in veterans.

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Opinion: I lost my son to OxyContin. ‘The Fall of the House of Usher’ is my Sackler revenge fantasy

STAT

Editor’s note: This essay contains spoilers for the Netflix show “The Fall of the House of Usher.” “W atch “ The Fall of the House of Usher” on Netflix when you can. F**cking Great! Totally based on the Sacklers—Fictional obviously but so damn good!

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STAT+: In major test for prime editing, scientists successfully correct mutations in monkeys

STAT

Prime Medicine said Friday it successfully used a new, ultra-versatile form of genetic surgery called prime editing to edit liver cells in monkeys. The results, presented at the European Society of Gene & Cell Therapy meeting in Brussels, are a major step for a technology that could transform treatment of numerous diseases. “I think the big celebration here is we’re showing, in primates, for the company, that we have a delivery system that is working and is safe,” said J

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STAT+: ALS patients support bill that could help patients with other rare diseases

STAT

WASHINGTON — A month after advisers to the Food and Drug Administration overwhelmingly voted against the experimental ALS drug NurOwn, a Senate committee is considering a bill that would allow provisional approvals of the drug and other investigational treatments for rare, incurable diseases. Balancing high approval standards and fast access to promising drugs has always been a wobbly act.

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‘We’re absolutely making it too hard’: The complexity of adult immunization delivery hinders vaccine uptake

STAT

Alison Buttenheim was floored by a sign she saw in her doctor’s office when she went to get the first jab of the two-dose shingles vaccine to protect her against painful flare-ups of varicella zoster. “Medicare patients cannot receive Tdap or zoster vaccines here. They need to obtain [them] at their pharmacy. If they receive it here, they need to pay out of pocket,” the notice read.

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Giant sloths and woolly mammoths: Mining past creatures’ DNA for future antibiotics

STAT

PHILADELPHIA — Cesar de la Fuente believes the next breakthrough antibiotic might come from animals that have been dead for thousands of years. Since 2021, his lab here at the University of Pennsylvania has built algorithms to trawl genetic databases for protein fragments, called peptides, with microbe-squashing properties. They started with human DNA.

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AstraZeneca, maker of FluMist, seeks to allow at-home administration of vaccine

STAT

People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home. AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children.

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Maternal Covid-19 vaccination offers infants immunity for up to 6 months

STAT

The risks of severe neonatal morbidity, neonatal death, and admission to the neonatal intensive care unit were all significantly lower during the first month of birth in infants whose mothers were vaccinated against Covid-19, and protection against the virus continued for up to six months after birth, according to a new study published Monday in JAMA Pediatrics.

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What will it take to end the crisis of Black deaths in the U.S.?

STAT

In the last two decades, Black Americans have suffered 1.63 million excess deaths compared to white Americans. Experts gathered at the STAT Summit in Boston last week to discuss the crisis of Black deaths in the U.S. and interventions that can help advance health equity. “If we continue to have a maternal health crisis, if we continue to have an infant mortality crisis … then we’re going to potentially see a situation or circumstance where Black people can be extinct in the

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STAT+: For Parkinson’s disease, advances spurred by Apple Watch offer a glimmer of hope

STAT

Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood. But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain dis

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STAT+: Sarepta’s Duchenne gene therapy fails to meet primary endpoint in pivotal trial

STAT

Sarepta Therapeutics said Monday afternoon that its gene therapy for Duchenne muscular dystrophy failed to improve muscle function compared to a placebo in a large clinical trial — likely a major disappointment for patients and doctors who have been desperately awaiting the treatment for years. The company said all patients in the study improved and that secondary measurements indicated the drug was having an effect.

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Fixing America’s health insurance woes is ‘actually very simple,’ says leading economist

STAT

Fixing the U.S. health care system can seem like a herculean task. But the solution is “actually very simple,” according to Massachusetts Institute of Technology economist Amy Finkelstein. In their recent book “ We’ve Got You Covered: Rebooting American Health Care ,” Finkelstein and Stanford economist Liran Einav describe how years of research have led them to the conclusion that the best way forward is for the U.S. to offer universal basic health care coverag

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Researchers try to tease out possible ties between long Covid and menopause

STAT

When she stopped getting her period in March 2022, Daryn Schwartz wasn’t especially concerned. At 42, she had recently come off birth control, and figured her cycles were still adjusting. When it hadn’t come back by the summer, she sought gynecological care, but was told to wait it out. So she did, with no changes. She was having other symptoms, too — fatigue, chronic pain, and difficulty focusing.

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STAT+: UnitedHealth discontinues a controversial brand amid scrutiny of algorithmic care denials

STAT

UnitedHealth Group and Optum are getting rid of the name of their tech-driven care management company just months after the company faced congressional criticism over the use of its algorithms to cut off payments for patients’ care. Discontinuing the NaviHealth name is part of a broader rebranding of Optum’s division that provides services to people at home and in post-acute facilities.

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CDC recommends rationing of RSV shot due to shortages

STAT

The Centers for Disease Control and Prevention has recommended rationing an important monoclonal antibody product to protect young infants from RSV due to strained supply of the new product, Sanofi’s Beyfortus. In a health alert issued Monday, the CDC said clinicians should prioritize available doses for babies at highest risk from respiratory syncytial virus, reserving 100-milligram doses for infants under the age of 6 months and those with underlying health conditions that put them at h

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Zuckerberg and Chan announce a New York biohub to build disease-fighting cellular machines

STAT

Meta founder Mark Zuckerberg and his wife, pediatrician and philanthropist Priscilla Chan, announced on Wednesday plans to invest $250 million over 10 years to establish a new “biohub” in New York City focused on building a new class of cellular machines that can surveil the body and snuff out disease. The new initiative, publicly revealed at the 2023 STAT Summit and previewed exclusively to STAT, is the latest program from the Chan Zuckerberg Initiative, or CZI, a company the coup

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STAT+: Oncologists more likely to provide low-value care after receiving pharma money, study finds

STAT

Oncologists were more likely to provide low-value cancer care after receiving money from pharmaceutical companies, and the findings raise questions about the extent to which industry influence may have led to patient harm, according to a new study. The study looked at two scenarios: medications that were not recommended for treating a particular cancer, such as denosumab, which is administered for prostate cancer, and GCSF medications that are used to stimulate the bone marrow to make blood cell