Tue.Mar 05, 2024

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Government, Industry Leaders Address the Growing Issue of PBM Practices

Drug Topics

Health care professionals, industry leaders, and politicians gathered for a virtual roundtable to discuss the state of the PBM industry.

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FDA Clears First OTC Continuous Glucose Monitoring, Dexcom Stelo Glucose Biosensor System

Pharmacy Times

The continuous glucose monitoring system will be available for purchase online and without a prescription starting in summer 2024.

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Breaking: FDA Clears Dexcom Stelo, First OTC Continuous Glucose Monitor

Drug Topics

Dexcom's Stelo will be available in summer 2024.

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How the U.S. is sabotaging its best tools to prevent deaths in the opioid epidemic

STAT

The opioid overdose epidemic has burned through the U.S. for nearly 30 years. Yet for all that time, the country has had tools that are highly effective at preventing overdose deaths: methadone and buprenorphine. These medicines are cheap and easy to distribute. People who take them use illicit drugs at far lower rates, and are at far lower risk of overdose or death.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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FDA Grants Fast Track Designation For EP0031/A400 to Treat RET-Altered NSCLC

Pharmacy Times

The next-generation SRI was previously granted an Orphan Drug Designation in November 2023 and its safety and efficacy are currently being evaluated in clinical trials.

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STAT+: Novo Nordisk’s diabetes drug Ozempic cuts risk of kidney disease progression, trial shows

STAT

LONDON — Novo Nordisk’s diabetes medication Ozempic cut the risk of patients developing advanced kidney disease or dying from kidney or heart complications, the company said Tuesday, adding to the evidence the wildly popular drug has broader health benefits for patients beyond addressing their diabetes. Overall, Ozempic lowered the risk of progression of patients’ kidney disease and of related health events by 24% versus placebo, according to the topline results.

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Watch: Why fentanyl withdrawal is agony and how medication can prevent it

STAT

Over 2 million Americans have opioid use disorder, according to some estimates. Illicit opioids such as heroin and fentanyl were responsible for over 80,000 U.S. overdose deaths in 2023. Despite the known risks, these drugs are notoriously hard to stop using — due in large part to how debilitating withdrawal can be.

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Health Care Transparency Comes in Many Forms, But Is Much Needed in Patient Care

Pharmacy Times

Laws can help eliminate common barriers to transparency but are not the only way to achieve health care transparency.

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STAT+: Harvard longevity scientist sparks furor with claim about reversing aging in dogs

STAT

Renowned Harvard University geneticist and longevity researcher David Sinclair recently made an astonishing assertion: Scientists had developed the first pill — well, a soft, beef-flavored chew — “proven to reverse aging” in dogs. Which miracle molecules delivered this supposed scientific breakthrough, he didn’t say.

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Environmental Toxin BPA Affects Gut Microbial Communities in Children

Pharmacy Times

Children with normal weight had different community relationships compared to children with overweight or obesity.

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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+: FDA clears first over-the-counter continuous glucose monitor

STAT

For the first time, anyone in the United States will soon be able to buy a continuous glucose monitor without a prescription. The Food and Drug Administration authorized Dexcom on Tuesday to start selling a new product, called the Stelo, to adults who do not use insulin. The product is scheduled to hit the market this summer.    The Stelo product is explicitly designed for people with type 2 diabetes who are not reliant on insulin, or people without diabetes who are curious about

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FDA Approves 2 Denosumab Biosimilars for All Indications of Reference Products

Pharmacy Times

Denosumab-bbdz (Wyost; Sandoz) and denosumab-bbdz (Jubbonti; Sandoz) are approved as interchangeable for all indications of Xgeva (denosumab; Amgen) and Prolia (denosumab; Amgen).

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It’s time to stop treating menopause like a disease, researchers argue in series of Lancet articles

STAT

One in eight people is postmenopausal, and about 50 million women enter menopause every year. A new essay published on Tuesday in The Lancet argues that it’s time to stop treating them like patients suffering from a disorder. The article calls for a reframing of menopause and a management approach that is not simply focused on medical interventions that relieve symptoms.

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FDA Approves Eye Drops to Treat Inflammation, Pain After Ocular Surgery

Drug Topics

Clobetasol propionate ophthalmic suspension 0.05% is the first ophthalmic clobetasol propionate product approved by the FDA and is the first new ophthalmic steroid on the market in over 15 years.

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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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Q&A: Microsoft research head explains how generative AI could help doctors be more human

STAT

Generative AI is having a moment. Peter Lee, who oversees Microsoft’s approach to health care and co-authored the 2023 book “ The AI Revolution in Medicine: GPT-4 and Beyond, ” calls it “the most transformative tool ever developed in all aspects of health care and medicine.” Microsoft has been collaborating with the organization OpenAI for several years, so when OpenAI released ChatGPT in November 2022, Lee quickly realized there was a need to educate the medic

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Insurers report significant reduction in claims data following Change Healthcare hack

Fierce Healthcare

Humana and Elevance Health said they are seeing a 15% to 20% reduction in data from providers after the Change Healthcare hack, company execs said during an industry conference March 5. | Both Humana and Elevance Health said the Change Healthcare cyberattack is affecting its claims data from providers. The plans are increasingly relying on Availity, a competing clearinghouse to handle claims processing.

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FDA advisory panel recommends a streamlined flu vaccine for next fall

STAT

When Americans line up for flu vaccines next fall, they will almost certainly be getting vaccines that no longer contain protection against a family of flu viruses that appears to be extinct. Experts who advise the Food and Drug Administration on vaccine-related issues voted unanimously on Tuesday to recommend that the FDA approve trivalent flu vaccines for the 2024-2025 season, instead of the quadrivalent, or four-in-one, shots that have been the industry standard for the past decade or so.

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Novo Nordisk's success with Ozempic in diabetes and kidney disease patients isn't enough for investors

Fierce Pharma

A trial of Novo Nordisk's Ozempic on diabetes and kidney disease patients found that it reduced the risk of disease progression and death by 24%.

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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+: WTO proposal for Covid diagnostics and therapeutics waiver is abandoned

STAT

After 18 months of debate, the World Trade Organization failed to adopt a controversial proposal to waive intellectual property protection for Covid-19 diagnostics and treatments, ending a furious attempt by civil society groups to bolster global access to needed medical products. The failure was not a surprise. Since the proposal was introduced, the pharmaceutical industry — and several key countries where large drugmakers are headquartered, including the U.K. and Switzerland — su

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FDA Grants Orphan Drug Designation for CBL-514 to Treat Adult Patients With Dercum Disease

Pharmacy Times

This designation makes CBL-514 the first drug to receive both Orphan Drug Designation and Fast Track Designation for the treatment of Dercum disease.

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Air quality improvements belie rising racial and ethnic disparities in pollutant-related deaths, study finds

STAT

The U.S. is making progress in reducing the public health consequences of air pollutants and fine particulate matter. But these improvements have not benefited everyone equally, according to a new study published on Wednesday in the journal Environmental Health Perspective. Researchers found an overall drop from 2010 and 2019 in death and disease linked to nitrogen dioxide (NO2), an air pollutant produced from fossil fuel burning, and fine particulate matter (PM2.5) pollution.

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FLOW Trial Results Demonstrate Positive Kidney Outcomes With Semaglutide

Pharmacy Times

In the study, investigators found superior kidney outcomes with injectable semaglutide (Ozempic) for individuals with type 2 diabetes and chronic kidney disease.

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STAT+: Large insurers say up to one-quarter of claims run through Change Healthcare

STAT

Some of the country’s biggest health insurers said Tuesday that up to one-quarter of their claims are run through Change Healthcare, UnitedHealth Group’s technology company that sustained a massive cyberattack two weeks ago. Speaking at investor conferences, executives from Humana, Elevance Health, and CVS Health, which owns Aetna, said the biggest impact they’re seeing is fewer bills coming in from providers.

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Prenatal Exposure to General Anesthesia Increases Risk of Subsequent ADHD, Behavioral Disorder Diagnosis

Pharmacy Times

There have been ongoing concerns about the long-term effects of prenatal exposure on neurodevelopment.

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STAT+: Q&A: Nora Volkow on how to get ‘at least 50% less people dying’ from opioid overdose

STAT

In 2003, the year Nora Volkow was appointed director of the National Institute on Drug Abuse, roughly 4,000 Americans died of opioid overdose. In the two decades since, the overdose crisis has morphed into a full-fledged public health emergency, with 80,000 Americans dying from opioid overdoses each year. But in that stretch, relatively little has changed about the way the U.S. treats opioid addiction.

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FDA Approves Interchangeable Denosumab Biosimilar

Drug Topics

The agency approved denosumab-bddz under two brand names: Wyost and Jubbonti.

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Where’s Lilly’s Alzheimer’s approval?

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here. I’d like to heartily recommend you  check out Part 1 of The War on Recovery , a yearlong STAT investigation into how the U.S. denies lifesaving medications to people with opioid addiction.

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Bayer CEO launches ‘full-scale effort’ to rejuvenate pharma pipeline, tables split-up but warns not never

Fierce Pharma

Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as man | Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as many investors had hoped for.

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CORe Initiative Looks to Transform Cancer Research Through Increased Diversity and Data Sharing

Pharmacy Times

The CORe initiative is aimed at promoting inclusivity, reducing startup time for clinical trials, and facilitating data sharing to address recruitment and retention challenges in cancer research at community oncology sites.

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Surprise Enhertu rejection follows NICE process change

pharmaphorum

NICE has rejected the use of AstraZeneca and Daiichi Sankyo’s Enhertu as an NHS treatment for advanced HER2-low breast cancer, a decision that the companies have described as “devastating”.

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Vanda's jet-lag approval hopes for Hetlioz quashed with FDA hearing rejection

Fierce Pharma

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. | Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Now, following a lawsuit and a protracted back-and-forth with the U.S. regulator, the FDA has crushed Vanda’s bid.

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Walgreens plans strategic review of business, including the role of its retail stores, healthcare assets, CEO says

Fierce Healthcare

Walgreens is gearing up for a strategic review of its business, including the role of its retail pharmacy stores and its healthcare assets, as company leadership and the board plot the future direc | The drugstore retail giant making moves to improve its financial performance after a massive growth spurt in which it expanded its healthcare business segment.

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Can creative analytics solve your D2C paid search headache?

pharmaphorum

Learn how creative analytics can help solve your Direct-to-Consumer paid search challenges. Discover how data-driven insights can optimise your performance with HCPs.

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