Wed.May 03, 2023

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Breaking: FDA Approves First-Ever RSV Vaccine

Drug Topics

The vaccine is approved for use in adults aged 60 and older to prevent lower respiratory tract disease caused by RSV.

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The Role of the Pharmacy Technician Expands into Pharmacy-Based Community Health Worker

Pharmacy Times

The advent of pharmacy-based community health workers has helped to expand and codify the pre-existing community-based efforts of pharmacy technicians to reach even outside of medication access.

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Trending Sources

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Ghana Becomes First Country to Approve ‘World-Changing’ Malaria Vaccine

Drug Topics

The Ghana Food and Drugs Authority approved R21 for children aged five months to three years.

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For Eli Lilly’s head scientist, Alzheimer’s results cap a 25-year scientific quest

STAT

If you flip to the 1,031st page of the May 1998 edition of the Journal of Cell Biology, you’ll find the first scientific byline for Daniel Skovronsky, then a young trainee at the University of Pennsylvania, on an article describing how beta-amyloid, a vexing molecule thought to play a role in Alzheimer’s disease, was more complicated than the field understood.

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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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Employment Status, Contraceptive Use, and the ACA

Drug Topics

According to a recent study, the association between employment status and contraceptive use observed in a period before the Affordable Care Act (ACA) was not found after the ACA ended.

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Though Specific Therapies Are Few, Clinical Trials Promise Progress for IgA Nephropathy

Pharmacy Times

In addition to 2 FDA-approved options, several clinical trials are investigating other potential treatments for immunoglobulin A nephropathy.

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More Trending

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Consider Real-World Barriers When Deciding on Treatment for Diabetic Macular Edema

Pharmacy Times

Pharmacists will play a growing role in the use of biosimilars and guiding patients through the switching process.

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Telehealth providers cheer DEA move to temporarily extend virtual prescribing flexibilities

Fierce Healthcare

Telehealth providers cheer DEA move to temporarily extend virtual prescribing flexibilities hlandi Wed, 05/03/2023 - 15:16

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STAT+: Immunogen ovarian cancer drug shown to extend patients’ lives

STAT

A drug approved in November as the first new treatment for advanced ovarian cancer in over seven years has now been shown to extend patients’ lives, its developer, Immunogen, said Wednesday. Immunogen released data from a trial comparing the new drug, Elahere, to traditional chemotherapy in 453 ovarian cancer patients who had already progressed on at least one other therapy and had a particular protein marker on their tumor.

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Pharma á la carte – 05/04/2023

The Honest Apothecary

Here I share some of the latest news, articles, editorials, or blog posts that fall generally under the theme of Pharma or healthcare. I might throw in a something off-topic from time to time which I found while wandering throughout the endless hallways and corridors of the internet. All article shared will be free to read and not locked behind an annoying paywall.

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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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STAT+: In early glimpse at data, Akili’s video game shows positive results with adults with ADHD

STAT

Akili Interactive on Wednesday revealed earlier-than-expected top-line clinical trial results suggesting its video game treatment for attention deficit hyperactivity disorder is effective for adults. That’s very good news for a company that’s racing to reach more patients in hopes of building a sustainable business.

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How long does it take for vitamin D to work?

The Checkup by Singlecare

Vitamin D is essential for keeping bones strong. This nutrient also contributes to healthy immune systems, muscle movement, and nerve function. Still, nearly 1 in 4 Americans experiences vitamin D deficiency. Though vitamin D can be increased through diet and sun exposure, some people need to take daily vitamin D supplements to correct low levels of this essential nutrient.

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STAT+: Eli Lilly’s Alzheimer’s therapy slowed patients’ rate of cognitive decline, data show

STAT

A new treatment for Alzheimer’s disease developed by Eli Lilly slowed patients’ rate of cognitive and functional decline by 35% compared to placebo, the company said Wednesday, paving the way for a submission to the Food and Drug Administration and boosting hopes for a new class of Alzheimer’s drugs. But the positive outcome of the study involving the drug, called donanemab, could be tempered by the deaths of two patients, and possibly a third, from a type of brain swelling

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Inhaled Isopropyl alcohol a possible treatment for nausea and vomiting in ED

Hospital Pharmacy Europe

Inhaled isopropyl alcohol may represent a useful treatment for the emergency department management of patients with nausea and vomiting Nausea and vomiting were responsible for 1.6 million US emergency department (ED) visits in 2007. Current antiemetic drugs including ondansetron and metoclopramide are effective. Despite this, evidence to support the efficacy of one drug over any other is lacking.

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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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STAT+: Vinod Khosla predicts AI doctors could be here sooner than you think

STAT

Sun Microsystems co-founder Vinod Khosla is famous for predictions that have helped usher in the high tech world we live in today — and made him very wealthy in the process. On Wednesday, he made another bold forecast: A fully computerized doctor could be seeing patients before the decade is out. “Within 5 to 6 years, the FDA will approve a primary care app qualified to practice medicine like your primary care physician,” he said onstage at the STAT Breakthrough Summit

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Higher cardiac troponin levels in acute dyspnoea increases mortality risk

Hospital Pharmacy Europe

Increased cardiac troponin levels in acute dyspnoea represents a mortality risk even in those without an acute myocardial infarction Acute dyspnoea is a common complaint within an emergency department (ED). Dyspnoea also commonly presents in nearly two-thirds of patients experiencing an acute myocardial infarction. Consequently prompt patient assessment to identify the underlying cause of the dyspnoea is vital.

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Don’t ignore potential microbial causes of Alzheimer’s and other chronic diseases, researchers say

STAT

SAN FRANCISCO — On a day when pharma giant Eli Lilly announced positive results from a clinical trial of an Alzheimer’s drug that clears knotty clumps of protein from the brain, researchers at STAT’s Breakthrough Summit discussed another promising though preliminary approach to treating the disease: targeting viruses and bacteria.

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Hospital margins inch up in March as volume, revenue growth outpace expenses

Fierce Healthcare

Hospital margins inch up in March as volume, revenue growth outpace expenses dmuoio Wed, 05/03/2023 - 12:39

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DEA will delay telemedicine restrictions for buprenorphine, Adderall, and other drugs

STAT

The Drug Enforcement Administration is holding off on making sweeping changes to the way certain drugs can be prescribed via telemedicine — for now. The DEA announced Wednesday that it was temporarily extending its Covid-era emergency telehealth policies, allowing doctors continued leniency in how they prescribe some controlled substances. The affected medications include buprenorphine, the most common medication used to treat opioid addiction, and stimulants like Adderall used to treat A

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Digital transformation to drive biomanufacturing market

European Pharmaceutical Review

A market report has shown that the digital biomanufacturing market is anticipated to grow at a compound annual growth rate (CAGR) of 11 percent between 2023-2035, driven largely by digital transformation. Influencing factors identified in the report include higher competition, competitive pricing and inflation rate, technological advancements and evolving regulatory guidelines.

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RJ Reynolds is threatening to sue vape shops for selling flavored vapes

STAT

WASHINGTON – The tobacco giant RJ Reynolds is threatening to sue small vape shops if they do not stop selling flavored vapes, according to two letters obtained by STAT. The letters, both of which were sent in March, give the vape shops just a few days to confirm they will no longer sell flavored tobacco products. Failure to comply could result in “legal action, and the costs, attorneys’ fees, and adverse publicity to which a lawsuit would subject [the vape shop],” the

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Talkspace boosts 2023 outlook buoyed by strong growth in payer, employer business

Fierce Healthcare

Talkspace boosts 2023 outlook buoyed by strong growth in payer, employer business hlandi Wed, 05/03/2023 - 11:40

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STAT+: CAR-T research is flourishing but is hampered by outdated precautions, experts say

STAT

Twenty years ago, CAR-T cell therapy was not quite “believed in,” said Michel Sadelain, director of the Center for Cellular Engineering at Memorial Sloan Kettering Cancer Center. It was hard to find patients to put in a trial, he said, because physicians were skeptical of the new technology. Then, when the first patients were successfully treated, there was “suddenly this turnabout, a tsunami as some would say, of young scientists and not-so-young scientists embracing this.

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European Commission approves CAR T therapy for lymphoma

European Pharmaceutical Review

The European Commission (EC) has granted approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. The CAR T-cell therapy has a 4-1BB costimulatory domain which enhances the expansion and persistence of the CAR T cells. The treatment is indicated for adults with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) who re

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FDA approves first RSV vaccine, a long-sought scientific achievement

STAT

The Food and Drug Administration on Wednesday licensed the first-ever vaccine for respiratory syncytial virus, or RSV , completing an elusive quest that has been decades in the making. The product, GSK’s Arexvy, was approved for adults ages 60 and older. GSK beat a crowded field of competitors to cross the finish line first. A vaccine that was developed by Pfizer and aimed at the same demographic is expected to be approved by the end of the month.

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How a Medicare-X model could impact patients, hospitals: Urban Institute

Fierce Healthcare

How a Medicare-X model could impact patients, hospitals: Urban Institute fdiamond Wed, 05/03/2023 - 16:40

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Now 18, the first child to ever receive CAR-T cancer therapy is ready for a new identity

STAT

The Food and Drug Administration approves dozens of cancer drugs every year, but the vast majority of them offer gradual improvements. A treatment might shrink tumors in a third of patients, or extend survival by a couple months, and a company can still haul in billions. The results were much more revolutionary when, at six years old, Emily Whitehead became the first child to receive CAR-T cell therapy, in which researchers arm a patient’s own immune cells against their cancer.

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Placer.ai sizes up retail sector foot traffic in Q1

Drug Store News

Seven of the 10 best-performing states—Massachusetts, Rhode Island, Pennsylvania, New Jersey, Connecticut, New York and Vermont—were in the Northeast.

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Opinion: The Global North can’t solve its health care worker shortage by stealing from the Global South

STAT

The U.S. is facing unprecedented  health care labor shortages  and related cost pressures. In the U.K., the National Health Service has witnessed its  largest nursing strike in history  alongside  junior doctor strikes , which have been prompted by staffing shortfalls and inadequate pay.  Europe is endangered  by an aging workforce, growing absenteeism, and health care workers simply quitting the field.

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Southeastern Grocers urges customers to take action during National Hurricane Preparedness week

Drug Store News

As part of its preparedness efforts, the retailer is offering $20 in free groceries as a vaccine incentive in all in-store pharmacies through June 30.

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STAT+: The CEO of 23andMe says people are willing to share health data — if ‘treated like adults’

STAT

When it comes to personal health information, many people are actually willing to share their data, according to Anne Wojcicki, co-founder and CEO of genetic testing company 23andMe. But the health care system has to start treating people less like test subjects, and more like people who want to contribute to medical research. “There needs to be more of that mindset: give people choice, give people transparency.

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Medicare Advantage enrollment officially crosses 50% of beneficiaries: KFF

Fierce Healthcare

Medicare Advantage enrollment officially crosses 50% of beneficiaries: KFF pminemyer Wed, 05/03/2023 - 14:12

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After early-stage breast cancer, interrupting endocrine therapy to become pregnant didn’t raise risk of recurrence

STAT

Women who’ve been treated for hormone-sensitive breast cancer often face five to 10 years of endocrine therapy to lower the chances of their tumors coming back. Because that drug regimen is toxic during pregnancy, women who haven’t begun their families yet may lose that chance before they even try. New research published Wednesday in the New England Journal of Medicine suggests there might be another option.

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Cibo Vita debuts two Nature’s Garden products

Drug Store News

Nature’s Garden Oat Milk Chocolate Covered Strawberry Almonds and Probiotic Strawberry Yoggies are making their debut from Cibo Vita.

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