2023

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FDA Approves Empagliflozin for Adults With Chronic Kidney Disease at Risk of Progression

Pharmacy Times

Empagliflozin (Jardiance) demonstrated a 28% relative risk reduction, with an absolute risk reduction of 3.6% per patient-year at risk in the treatment of chronic kidney disease.

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Genetically altered pig heart transplanted into a human for the second time

STAT

In a new test of xenotransplantation , a medical team at the University of Maryland Medical Center announced Friday that, for only the second time in history, it had transplanted a heart from a genetically engineered pig into a human. The surgeons performed the eight-hour procedure Wednesday without complications. As of Friday afternoon, the organ recipient, a 58-year-old Navy veteran and former vaccine researcher at the National Institutes of Health named Lawrence Faucette, is awake, able to si

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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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Geisinger doubles down on collaboration with Best Buy Health, Geek Squad to support tech-driven care in the home

Fierce Healthcare

As at-home healthcare becomes more tech-driven—think wireless biosensors and connected blood pressure cuffs—it creates more logistical challenges for providers. | Geisinger's pilot program with Best Buy's Geek Squad resulted in quicker access to care, better adherence to care plans and more positive outcomes for chronic care patients, the organizations said.

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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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Walgreens, Global Healthy Living Foundation to host free virtual health event

Drug Store News

In the “Making the Most of Your Vaccines” virtual event, experts will discuss the role pharmacists, nutrition, exercise and mindfulness can play in one’s vaccination experience.

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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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5 mucus-killing foods

The Checkup by Singlecare

Whether it’s allergies, the common cold, the flu, or COVID, there are a number of reasons why you might be running to the tissue box more often than usual to handle congestion and pesky mucus (otherwise known as phlegm). If you find yourself with a stuffy nose or a phlegmy cough, there are a number of foods, at-home remedies, and over-the-counter medications that can provide some much-needed relief.

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The 2023 PharmaVoice 100

PharmaVoice

This year’s honorees are influential and devoted leaders lifting the pillars of the industry to new heights.

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FTC fires shot across pharma's bows over 'improper' patents

pharmaphorum

FTC fires shot across pharma's bows over 'improper' patents Phil.

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Revolutionizing Drug Development Through Artificial Intelligence, Machine Learning

Pharmacy Times

The seamless integration of artificial intelligence and machine learning has the potential to accelerate research and enhance efficiency in a new era of personalized medicine.

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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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FDA Approves MDMA for Clinical Trial Use Investigating Schizophrenia

Pharmacy Times

The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.

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COVID-19 Infection Could Be Detected in Lungs, Heart, Causing Inflammatory Damage

Pharmacy Times

Investigators found thinner ventricular walls, disorganized and ruptured myocardial fiber, mild inflammatory infiltration, and mild epicardia or interstitial fibrosis in the hearts of mice infected with COVID-19.

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HHS Recommends Cannabis Move From Schedule 1 to Schedule 3, the Result Will Impact Opportunities for Drug Research

Pharmacy Times

Moving cannabis to Schedule 3 will make it easier to research, resulting in the development and creation of new cannabinoid-based pharmaceuticals, with notable potential in oncology.

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Increased Vitamin D Intake Can Decrease Symptoms of Depression, Anxiety

Pharmacy Times

Although findings indicate a relationship between vitamin D and mood disorders, further research is needed to clarify efficacy of specific vitamin D levels, as well as supplement dose and form.

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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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Study Shows Not All IVIG Products Are Created Equal in Alzheimer Disease

Pharmacy Times

One IVIG product showed overall improvement in neuroprotection, including alleviating cognitive decline and ameliorating AB deposition in Alzheimer disease.

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Markey and Manchin urge FDA to stop its study of opioids for chronic pain

STAT

Two Democratic senators are warning the Food and Drug Administration not to proceed with a controversial trial meant to measure opioids’ effectiveness as a chronic pain treatment. In a letter shared with STAT, Sens. Ed Markey (D-Mass.) and Joe Manchin (D-W.Va.) warned FDA Commissioner Robert Califf against using the method in the agency’s ongoing work to evaluate whether opioids, despite their widespread use, are effective at treating chronic pain.

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In North Carolina, a radical experiment targets social determinants of health with fresh produce and safe housing

STAT

Late last summer, Elizabeth Jacques brought her youngest daughter, Elena, for a medical checkup. At the time, Jacques and her family were experiencing housing instability after a two-year legal battle with their former landlord, who refused to clean up their unsanitary, unlivable conditions. For Jacques, it was obvious she had to leave a housing situation that was putting her family’s health at risk.

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FTC sues private equity firm Welsh Carson, U.S. Anesthesia Partners for allegedly creating a monopoly

STAT

The Federal Trade Commission has sued U.S. Anesthesia Partners and its private equity owner, Welsh, Carson, Anderson & Stowe, alleging in federal court the two partners formed a monopoly in order to drive up prices and boost their profits. Normally, the FTC sues the company that it believes has violated antitrust law. But this lawsuit is novel by also going after a private equity sponsor that it believes hatched the entire alleged scheme — and could serve as a warning to other private

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Ensuring Health Equity in Vaccination Access: How Pharmacies Can Work With Community Organizations

Pharmacy Times

Community pharmacies and organizations can collaborate to tailor strategies and interventions and address the challenges and specific needs of the community.

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Free Covid tests will be offered again to all U.S. households

STAT

The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs, in part to stimulate a domestic testing industry that has struggled with cratering demand for the rapid diagnostics. The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile.

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Does the risk of getting long Covid increase each time you get reinfected?

STAT

More than three years into the coronavirus pandemic, fewer and fewer people are experiencing their first Covid-19 infections. But as cases climb , those who’ve had the virus before may wonder: What are their chances of developing long Covid — and does the risk increase with each reinfection? Fatigue and brain fog may be the first post-infection symptoms that come to mind for long Covid, but lists compiled by the Centers for Disease Control and Prevention and by the World Health Org

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Opinion: Brain drain, skills loss, and other unintended consequences of overturning Roe v. Wade

STAT

Every day at the Kansas clinic where I perform abortions, I take care of pregnant people who have driven 10 hours or more across state lines for their procedures. They’re exhausted after moving mountains to get there: taking time off work, arranging child care, gathering funds. They’re excessively grateful, and their gratitude makes me sad.

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Physicians say transgender sports bans are a health issue

STAT

Almost half of U.S. states have banned or restricted trans youths’ access to gender-affirming puberty blockers, hormones, and surgery — and many of the same states are also targeting trans youths’ participation in sports. Twenty-three states ban trans youths from participating in school sports consistent with their gender identity, with some laws focusing on students from kindergarten through 12th grade and others including, or exclusively applying to, students at the colleg

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Why doesn’t the U.S. have more Black midwives?

STAT

In the wake of growing alarm over the disproportionately high rates of maternal mortality in the U.S., maternal health experts have been pushing for changes — including expanding the midwife workforce. Studies have shown that deliveries attended by midwives tend to have fewer complications and better outcomes, partially because midwife training relies less on medical intervention, leading to fewer C-sections.

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Opinion: Long Covid is a new name for an old syndrome

STAT

Long Covid goes by  many names. Today, it is no longer a new public health enigma, but the outlook for sufferers is no better than when the condition was first recognized in early 2020. Although its prevalence has recently decreased to 6% of the U.S. adult population, there has been no significant progress in understanding its causes, prevention, or treatment.

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Opioid Settlement May Spur Cannabis as Potential New Pharmacy Revenue Stream

Pharmacy Times

The opioid settlement framework could have a significant impact on the future of cannabis distribution and its role in health care.

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CDC recommends updated Covid vaccines for everyone 6 months and older

STAT

A panel of advisers to the Centers for Disease Control and Prevention voted 13-1 Tuesday to recommend updated Covid-19 booster shots for all Americans 6 months and older. CDC Director Mandy Cohen signed off on the recommendation hours later, and vaccines would be available within 48 hours. The recommendation applies to mRNA shots from Pfizer-BioNTech and Moderna, both of which were approved by the Food and Drug Administration Monday.

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Popular nasal decongestant doesn’t actually relieve congestion, FDA experts say

STAT

WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications stocked on store shelves.

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FDA approves updated Covid vaccines

STAT

The Food and Drug Administration announced Monday that it had greenlit two   updated Covid-19 booster shots in people as young as 6 months old, triggering a process that could see the Moderna and Pfizer-BioNTech vaccines become available in doctors’ offices, clinics, and pharmacies later this week. The updated approvals relate only to the two messenger RNA vaccines on the U.S. market.

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The food industry has tried to stack a key nutrition policy panel with its preferred experts, documents show

STAT

WASHINGTON — There’s a panel of 20 nutrition experts that has outsized influence on the American diet — and the food industry has worked hard to get friendly researchers into the group, new documents obtained by STAT show. The National Potato Council, for example, nominated one of the researchers behind an industry-funded study showing eating french fries each day doesn’t result in more weight gain than eating a comparable amount of almonds.

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Amid another rise in cases, Covid’s new normal has set in

STAT

Among people who are still paying attention to Covid-19 , there’s been a recent surge — not just in viral activity but in the concern once again being paid to Covid. Headlines announce that transmission is surging and hospitalizations for Covid are rising by alarming percentages. There’s debate in some places about whether or not to resume wearing masks.

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The ‘Hispanic Paradox’ intrigues a new generation of researchers determined to unravel it

STAT

For 40 years, researchers have unsuccessfully tried to explain — or debunk — the “Hispanic Paradox,” the finding that Hispanic Americans live several years longer than white Americans on average, despite having far less income and health care and higher rates of diabetes and obesity. Now, armed with more comprehensive data, powerful genomic tools, and a rich cultural awareness of the communities they study, a new generation of scientists is finally making headway.

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How a supplement company became a haven for health misinformation

STAT

On a Friday afternoon in July, as many New Yorkers fled the scorching city streets, a couple of dozen out-of-towners descended on Times Square. They came bearing gold letter balloons spelling out LFVN, the stock symbol for LifeVantage, the company they’d come to promote, and foam cutouts of its navy blue supplement bottles. LifeVantage’s chief executive officer, Steve Fife, rang the Nasdaq exchange’s closing bell, a celebration of the Utah-based company’s new products

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Opinion: Doctors in the U.S. can learn a lot about advocacy and activism from their Israeli counterparts

STAT

Israeli doctors are bracing for a fight. On Sept. 12, the Israeli Supreme Court is set to hear challenges to a core component of Prime Minister Netanyahu’s judicial overhaul — and he has refused to commit to abide by the ruling. Thousands of Israeli doctors have announced they will go on strike if Netanyahu chooses to ignore an adverse ruling.

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