Wed.Aug 07, 2024

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STAT+: How UnitedHealth turned a questionable artery-screening program into a gold mine

STAT

The nation’s largest health care company pressed thousands of its clinicians to use a thinly tested medical device to screen people for artery disease, dramatically boosting payments from the federal government for years even though many of the patients were not sick, a STAT investigation found. The result was a torrent of sometimes questionable diagnoses of peripheral artery disease.

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GLP-1 Agonists Show Promise in Treatment of Neurodegenerative Disorders

Pharmacy Times

Significant commonalities between type 2 diabetes and neurodegenerative disorders suggest that treatments effective for one condition may benefit the other.

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STAT+: The race to build better CRISPR delivery vehicles is heating up

STAT

If the first CRISPR decade was marked by a mad dash to evolve, engineer, and mine the bacterial universe for more and better genome-editing enzymes, so far the second seems to be all about three words: “Delivery. Delivery. Delivery.” Gene-editing technologies hold huge promise for treating hundreds, even thousands of inherited diseases.

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Study Finds Abacavir Increases Cardiovascular Risk in Patients With HIV

Pharmacy Times

Cholesterol-lowering agents, like statins, reduced the risk of major adverse cardiovascular events and cardiovascular disease in patients with HIV.

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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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Opinion: When life mirrors research: What a fall on the ice taught me about being Black and in pain

STAT

As I hurried to an important meeting about my Ph.D. dissertation one day in 2015, I slipped and fell on Iowa’s formidable winter ice. I quickly jumped up to prevent anyone from seeing me on the ground and got into my car. The immediate, excruciating pain told me that something really bad had happened. As I drove to my meeting in tears, I called my sister.

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Study Finds Safe, Effective Way of Infecting Participants With the Parasite Causing Leishmaniasis

Pharmacy Times

This breakthrough can be significant in the development for a vaccine and other preventative measures to protect individuals from leishmaniasis.

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Experts: Pharmacists Have a Crucial Role in the Treatment of Sarcomas in the Pediatric Setting

Pharmacy Times

Two pediatric oncology pharmacists emphasize pharmacists personalize supportive care, educate patients and their caregivers, advocate for patients, and collaborate with other health care workers.

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STAT+: Vertex, U.K. reach deal to provide CRISPR-based medicine to thalassemia patients in England

STAT

LONDON — Patients in England with a rare blood disorder will now be able to receive the world’s first CRISPR-based medicine, after drugmaker Vertex Pharmaceuticals and U.K. health officials struck a reimbursement deal for the pricey treatment. The National Institute for Health and Care Excellence, the U.K.’s cost-effectiveness watchdog, said early Thursday that it was recommending the treatment, called Casgevy, for certain patients with beta thalassemia, a condition that oth

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mRNA technologies: Looking beyond COVID vaccines

pharmaphorum

Explore the innovative applications of mRNA technologies beyond COVID-19 vaccines. Learn about the potential and future developments in this groundbreaking field.

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Novo Nordisk pulls its FDA heart failure submission for Wegovy, will reapply early next year

Fierce Pharma

Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold. | Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold. In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025.

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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 approves Purdue Pharma’s controversial new overdose-reversal medication

STAT

Purdue Pharma, the company best known for fueling the opioid crisis by misleadingly marketing the infamous painkiller OxyContin, received approval on Wednesday for a new auto-injector device used to reverse opioid overdoses.  The announcement represents the latest in a string of recent approvals for products that use nalmefene, essentially a more powerful version of its better-known chemical cousin, naloxone.

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Amgen's marketing efforts help boost Tepezza sales

Fierce Pharma

Amgen’s roller coaster ride known as Tepezza is ascending again. Is the thyroid eye disease (TED) treatment finally gaining momentum that is sustainable? | Amgen’s roller coaster ride known as Tepezza is ascending again. Is the thyroid eye disease (TED) treatment finally gaining momentum that is sustainable? In the second quarter, Tepezza generated $479 million in sales for an increase of 8% year over year and 13% sequentially.

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Centene Medicare Advantage subsidiary WellCare to retreat from 6 states in 2025

Fierce Healthcare

Centene is exiting six states through its WellCare Medicare Advantage subsidiary next year, investment bank Stephens has revealed. | WellCare is leaving six states next year, impacting more than 37,000 Centene members across the country.

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BioMarin keeps but scales down Roctavian gene therapy ops

pharmaphorum

BioMarin Pharma has decided not to divest its haemophilia A gene therapy Roctavian but is reining back its ambitions for the business, for now

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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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Pharmacosmos picks up G1 Therapeutics, FDA-approved drug Cosela in merger worth $405M

Fierce Pharma

In a deal worth approximately $405 million, Danish drugmaker Pharmacosmos has agreed to acquire G1 Therapeutics and the latter company's flagship product Cosela. | The companies will team up to expand the reach of G1's Cosela, which is used to reduce bone marrow damage associated with certain chemotherapy regimens.

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AI in the medical devices sector: Fostering innovation while navigating evolving regulations

pharmaphorum

Explore how artificial intelligence and machine learning are revolutionising the medical devices sector. Learn about the innovative technologies and how companies are navigating evolving regulations in this rapidly advancing field.

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STAT+: Supply issues weigh on Novo Nordisk as drugmaker stumbles with quarterly report

STAT

LONDON — An underwhelming earnings report and ongoing questions about increasing competition in the booming obesity medicine field sent Novo Nordisk’s shares down early Wednesday, as the company sought to project its ability to reach more patients by increasing the supplies of its medicines.   Novo shares were down about 5% after the company lowered its operating profit guidance to 20% to 28%, down from the 22% to 30% it forecasted in its last earnings report.

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Maximize Disease Awareness Months in the Pharmacy

Drug Topics

Make every month a celebration of wellbeing at the pharmacy by leveraging disease awareness initiatives.

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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+: Novo Nordisk pulls filings for Wegovy in heart failure as it waits for cardiovascular outcomes data

STAT

Novo Nordisk is pulling its regulatory submissions to expand the use of its obesity drug Wegovy for a common type of heart failure, saying that waiting for more data on cardiovascular outcomes could bolster its case. Trials of Wegovy in the condition, heart failure with preserved ejection fraction (or HFpEF), have primarily looked at the drug’s effects on symptoms and physical function.

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NeueHealth reveals another adjusted EBITDA profit, but EPS suffers

Fierce Healthcare

Coming off a recent debt financing round, NeueHealth reported a net loss but small adjusted EBITDA profit during its second-quarter earnings results. | NeueHealth's second-quarter results were without significant surprises, though the company noted a moderate increase in membership.

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STAT+: Medicare finalizes reimbursement rule for breakthrough medical devices

STAT

The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical device makers. Called Transitional Coverage for Emerging Technologies, the program gives device makers with products deemed “breakthrough” technology by the Food and Drug Administration a quicker way to secure Medicare coverage. The agency first introduced the rule last June.

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CVS Health kicks off multiyear, $2B cost-cutting effort

Fierce Healthcare

As it seeks to boost its financial fortunes, CVS Health has "identified a multiyear opportunity" to generate as much as $2 billion in savings, CEO Karen Lynch told investors Wednesday. | As it seeks to boost its financial fortunes, CVS Health has "identified a multiyear opportunity" to generate as much as $2 billion in savings, CEO Karen Lynch told investors Wednesday.

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Results of Study Find Irregular Sleep Patterns Associated With Diabetes Risk

Pharmacy Times

The ADA Clinical Practice Recommendations added sleep assessment for precision medicine in type 2 diabetes, supporting the wealth of information surrounding the association.

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Sangamo Therapeutics and Genentech team up to develop genomic medicines for neurodegenerative diseases

Pharmafile

Genomic medicine company Sangamo Therapeutics and Genentech have entered into a licensing agreement to develop intravenously administered genomic medicines to treat neurodegenerative diseases. Sangamo is expected to receive $50m in near-term upfront license fees and milestone payments after granting Genentech exclusive licensing for its proprietary zinc finger repressors – that are directed to the tau […] The post Sangamo Therapeutics and Genentech team up to develop genomic medicines for

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FDA Approves Vorasidenib for Adults, Pediatric Patients With Grade 2 Astrocytoma, Oligodendroglioma

Pharmacy Times

This marks the first FDA-approved systemic therapy for patients with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IHD1) or IDH2 mutation.

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Wegovy slowdown rattles Novo Nordisk investors

pharmaphorum

Weaker sales of obesity drug Wegovy cause a dip in Novo Nordisk's share price, but CEO says volume growth is strong and will accelerate in second half

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England's NICE clears Vertex, CRISPR's Casgevy in beta thalassemia after passing on sickle cell use

Fierce Pharma

On the rocky road to ensuring access to gene therapy Casgevy in the U.K., Vertex and CRISPR Therapeutics are making inroads by securing a thumbs up from England’s National Institute for Health and | The cost-effectiveness regulator recommended government funding for the groundbreaking gene-editing therapy in one of its two approved indications.

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Opinion: Give pharmaceutical execs the benefit of doubt — but they need to work for it

STAT

The polarized debate over drug pricing has generated cartoonish, sometimes colorful caricatures of the biopharmaceutical industry and its leaders. Critics of the industry have portrayed pharmaceutical leaders as ruthless, rapacious leaders who gouge patients to gratify greedy shareholders. While one might expect industry trade organizations to defend their leaders, their responses have sometimes portrayed leaders as powerless proxies of their shareholders whose product portfolios and profits wou

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After 2023 snub, Amneal clinches approval for extended-release Parkinson's disease med Crexont

Fierce Pharma

As multiple drugmakers race to bring novel, levodopa-based Parkinson’s disease treatments to the market, New Jersey’s Amneal has taken home the gold in the U.S. | Late Wednesday, the FDA granted approval to Amneal’s Crexont—formerly known as IPX203—which is an oral, extended-release formulation of the common Parkinson’s disease (PD) drugs carbidopa/levodopa (CD/LD).

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STAT+: CVS removes top Aetna leader as higher medical costs eat further into profits

STAT

CVS Health continued to pay out more than it expected for the medical claims of its Medicare Advantage enrollees in the second quarter, forcing the company to lower its estimates for this year’s profits for the second straight quarter. Those higher medical costs led CVS chief executive Karen Lynch to remove Brian Kane , the president of Aetna, the subsidiary that operates all health insurance plans.

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With Wegovy supplies back on tap, Novo Nordisk's obesity med doubles US prescriptions from start of year

Fierce Pharma

With supplies of its star obesity med Wegovy now largely unfettered, Novo Nordisk is dialing up its sales expectations for the remainder of the year—and teasing the potential for net price declines | With supplies of its star obesity med Wegovy now largely unfettered, Novo Nordisk is dialing up its sales expectations for the remainder of the year—and teasing the potential for net price declines on the immensely popular GLP-1.

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STAT+: FDA scolds Bristol Myers over a misleading website for a cancer treatment

STAT

The U.S. Food and Drug Administration has scolded Bristol Myers Squibb for making false and misleading claims about a lung cancer treatment on a website aimed at physicians. In an Aug. 1 letter , the agency admonished the company for touting the benefits of its Krazati medication by referencing efficacy data that did not support statements on the website designed for health care providers.

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Levicept says non-opioid drug cuts arthritis pain in phase 2

pharmaphorum

A non-opioid drug for pain developed by UK biotech Levicept, with a new mechanism of action, has shown it can reduce pain associated with osteoarthritis in a phase 2 trial.Neurotrophin-3 (NT-3) inhibitor LEVI-04 hit all its primary and secondary objectives in the trial, which enrolled 510 patients with moderate-to-severe osteoarthritis of the knee, raising the hope it could become a non-addictive option for patients needing chronic pain relief.

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