Mon.Sep 11, 2023

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Breaking: FDA Approves, Authorizes Updated Monovalent COVID-19 Vaccines

Drug Topics

Bivalent COVID-19 vaccines by both Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.

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Clinical Overview: Ongoing Review of GLP-1 Receptor Agonists for Suicidal Ideations

Pharmacy Times

Although GLP-1 receptor agonists have shown promise in promoting weight loss, they are prescription medications and should be used under the guidance of health care professionals.

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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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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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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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FDA Authorizes Updated COVID-19 Vaccine Formulations for Current Variants

Pharmacy Times

FDA grants updated Moderna and Pfizer-BioNTech COVID-19 vaccines with emergency use authorization to target currently circulating variants of the virus.

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STAT+: Experts fear private equity will pour gas on cardiology’s overuse problem

STAT

Coronary stenting is, by some measures , the most overused procedure in hospitals. The problem costs the health system millions and unnecessarily exposes patients to risks of blood clots, torn arteries, infections, and other life-threatening injuries. In 2020, Medicare started paying physicians to place stents, balloons, and perform other procedures designed to open clogged coronary arteries outside of hospitals, in less expensive outpatient settings.

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Biosimilar Adoption Hinges on Support From Patients, Providers

Drug Topics

The clinical pharmacist will play an important role as a medication expert, filling in for the role that pharmaceutical manufacturers once did in supporting patients and prescribers.

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Walgreens taps startup Pearl Health to expand into value-based primary care

Fierce Healthcare

On the heels of big-ticket acquisitions, Walgreens is ramping up its push into healthcare and is partnering with startup Pearl Health to get a foothold in the ongoing movement to value-based care.< | Walgreens' partnership with Pearl Health builds on the assets that the retail pharmacy giant has recently made investments in as it "moves more aggressively into healthcare," Steve Wogen, chief growth officer, told Fierce Healthcare.

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As kids, they underwent a common test for UTIs. As adults, it haunts them as a traumatic ‘nightmare’

STAT

This story contains descriptions of an invasive medical procedure and mention of sexual assault. It’s been nearly three decades since Shelby Smith underwent a series of invasive procedures as a young child to diagnose the cause of recurring urinary tract infections. But the trauma of the procedure, which required her to be restrained while a physician threaded a catheter up her urinary tract without sedation, still impacts her profoundly.

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Walmart exploring buying majority stake in primary care company ChenMed: media report

Fierce Healthcare

Retail giant Walmart is reportedly exploring buying a majority stake in primary care clinic operator ChenMed to expand its healthcare business. | Retail giant Walmart is reportedly exploring buying a majority stake in primary care clinic operator ChenMed to expand its healthcare business.

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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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Study Examines Links Between Sleep, Testosterone, and Cortisol in Aging Men

Pharmacy Times

Hypercortisolemia during the late afternoon and early evening is harmful and believed to cause insulin resistance observed with advanced age.

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AstraZeneca, working to grow Fasenra’s reach, touts positive trial against GSK's Nucala in new use

Fierce Pharma

Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.

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Amedisys shareholders sign off on $3.3B UnitedHealth deal

Fierce Healthcare

Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal. | Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.

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STAT+: Acelyrin, a rare IPO success, stumbles in its first big test

STAT

The biotech company Acelyrin, which raised more than $500 million in an IPO this year, ran into its first major setback Monday as its investigational anti-inflammatory drug missed the primary goal in a pivotal clinical trial. Acelyrin’s medicine, a subcutaneous treatment called izokibep, is meant to clear up lesions for patients with the common skin disease hidradenitis suppurativa, or HS, an inflammatory disorder that leads to abscesses and scars.

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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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L.A. Care must pay $1.3M settlement over data breaches that violated HIPAA: HHS

Fierce Healthcare

L.A. | L.A. Care, which provides coverage for about 2.9 million people in Medicaid, Medicare, and Affordable Care Act plans, was ordered to shore up its data protection systems.

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Doug Long Talks GLP-1 Sales Surge, Other Latest Health Care Trends

Drug Topics

The Vice President of Industry Relations at IQVIA gave a presentation at the 2023 PBMI Annual National Conference in Orlando, where he discussed everything from healthcare utilization during COVID-19 to spending on specialty drugs.

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Kaiser Permanente to pay $49M after 'undercover inspections' found medical waste, patient records in dumpsters

Fierce Healthcare

Kaiser Permanente has settled with the state of California for $49 million to resolve allegations that it was improperly disposing of hazardous medical waste—including body fluids—and thousands of | California law enforcement said it found "hundreds of items of hazardous and medical waste," such as medical tubing with body fluids, and paper records with thousands of patients' information in landfill-bound dumpsters.

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FDA raises questions about Onpattro's efficacy in Alnylam's bid to challenge Pfizer in lucrative heart disease use

Fierce Pharma

Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).

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Intravenous Immunoglobulin Can Induce Biological Response Due to Anti-Inflammatory Mechanisms

Pharmacy Times

Research into the mechanisms of intravenous immunoglobulin is often challenging due to the complexity of polyclonal preparations, including diversity, repertoires, blocking, or anti-idiotypic antibodies.

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Sandoz, nearing Novartis split, signs up to commercialize Samsung Bioepis' Stelara biosimiliar

Fierce Pharma

After plotting a course to grow by leveraging its biosimilar expertise, Sandoz has inked a deal to get involved in one of the industry's next major biosim debuts. | The blockbuster inflammatory med's patents begin to expire this year, leaving biosimilar makers scrambling for a piece of the large market. Versions from Amgen, Teva and Alvotech are expected to launch in early 2025.

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The Evolution of Precision Medicine in Pharmacy

Pharmacy Times

Precision medicine in pharmacy has the potential to revolutionize patient care by optimizing drug selection, dosing, and monitoring.

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Blue Cross NC plans to cut ACA premiums by 4% on average for 2024

Fierce Healthcare

At a time when inflation seems to be on the nation’s radar, it’s no surprise that Blue Cross and Blue Shield of North Carolina would tout that members in the healthcare plans it offers in the Affor | The rate decrease, approved by the North Carolina Department of Insurance, will lower total premiums by an estimated $130 million for enrollees in the insurer’s ACA plans.

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After key patent loss, Supernus touts positive results for nonstimulant ADHD med Qelbree

Fierce Pharma

A shortage of attention-deficit/hyperactivity disorder (ADHD) medicines has been ongoing for a year in the U.S. | Supernus is sharing positive results for its nonstimulant ADHD treatment, Qelbree, which was approved for children in 2021. In a poster presented over the weekend at Psych Congress 2023, Qelbree was shown to sharpen the focus of children 6 and older when combined with a stimulant.

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FDA Approves IND for CT7439, a Novel CDK12/13 Inhibitor to Treat Multiple Types of Advanced Solid Tumors

Pharmacy Times

The CDK12/13 inhibitor will be tested for efficacy and safety in patients with advanced solid tumors, such as breast, ovarian, and Ewing Sarcoma.

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Accessibility versus flexibility: MedPAC weighs Medicare Advantage standardization

Fierce Healthcare

Members of MedPAC, the Medicare Payment Advisory Commission, reiterated their broad support for simplifying the Medicare Advantage (MA) landscape for consumers during a meeting Sept. | Experts discussed how to best eliminate redundant options between Medicare Advantage plans while not impeding insurers' ability to differentiate its offerings.

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BioLineRx's Aphexda scores FDA nod to help myeloma patients undergo stem cell transplants

Fierce Pharma

After 10 years of stagnation, a new FDA approval could help more cancer patients become eligible for stem cell transplants. | The FDA approved motixafortide—also known as Aphexda—in tandem with the decades-old colony stimulating factor (CSF) filgrastim to mobilize hematopoietic stem cells for collection and autologous stem cell transplantation (ASCT) in patients with multiple myeloma.

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Walmart reportedly exploring buying majority stake in ChenMed

Drug Store News

ChenMed, which provides care to seniors, could be valued at several billion dollars in a deal that would be Walmart’s biggest health care foray yet, per a Bloomberg report.

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FTC settles first case on privacy, security of genetic information with 1Health.io

Fierce Healthcare

The FTC alleged 1Health.io failed to protect sensitive genetic and health data of consumers and deceived them about its privacy and security practices.

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HRG’s five notable products from August 2023

Drug Store News

HRG reviewed 25 products in the health category, 34 items in the wellness sector and 35 items in the beauty aisle to see which ones stood out as Products to Watch.

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J.D. Power: In crowded MA market, insurers should focus on trust to stand out

Fierce Healthcare

As the Medicare Advantage (MA) market continues to grow, insurers should be thinking about building trust with members to rise to the top of the pack, according to a

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AAM report: Generic, biosimilar drugs generate $408B in savings

Drug Store News

The U.S. healthcare system, including patients, employers and taxpayers, saved $408 billion in 2022 by using FDA-approved generic and biosimilar drugs, per the AAM's report.

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Does coffee help with weight loss?

The Checkup by Singlecare

Compared to individuals who maintain a healthy weight, people with obesity or who are considered overweight are at an increased risk for several serious health issues, including Type 2 diabetes , hypertension , heart disease , and even stroke. The good news? Even losing a small amount of weight ( 5%-10% of your body weight) comes with health benefits like more energy, improved blood sugar levels, and better sleep.

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Consensus statement on climate change and respiratory health issued by European Respiratory Society

Hospital Pharmacy Europe

Guidance on how global warming can be addressed in clinical practice has been outlined by the European Respiratory Society (ERS) in its latest consensus statement on climate change and respiratory health. Published in the European Respiratory Journal , the statement describes climate change as ‘an unfolding major planetary and health crisis’ , and a major threat to those with common lung conditions.

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Panda Express founders gift City of Hope $100M to explore Eastern medicine's role in cancer care

Fierce Healthcare

A new $100 million donation will help cancer research and treatment organization City of Hope establish a new evidence-based “integrative oncology” program that blends Eastern and Western medicine, | The largest charitable donation in City of Hope's history will help establish an evidence-based "integrative oncology" program that melds Eastern cultures' healing traditions, such as acupuncture or meditation, with cancer treatments more typical in the West.

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