Tue.Apr 16, 2024

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Socioeconomic Disparities Persisted Alongside Improving Vaccination Rates In US Over 11-Year Period

Drug Topics

Findings indicating that socioeconomic disparities widened gaps in vaccination timeliness signal the need for increased efforts to promote timely vaccination among children from families with lower income and those without private insurance.

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STAT+: UnitedHealth skips hearing in the wake of Change cyberattack, triggering call for subpoena

STAT

In the first federal hearing focused on the massive cyberattack on Change Healthcare , lawmakers had many important questions for UnitedHealth, which owns Change: Did it meet Health and Human Services’ cybersecurity performance goals ? Has UnitedHealth exploited physicians’ cash shortfalls caused by the Change outage to acquire struggling practices?

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Trending Sources

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UnitedHealth Group posts $1.4B loss in Q1 amid Change cyberattack fallout

Fierce Healthcare

UnitedHealth Group released its first-quarter earnings Tuesday morning as the industry continues to reel from the massive cyberattack on its Change Healthcare unit. | UnitedHealth Group released its first-quarter earnings Tuesday morning as the industry continues to reel from the massive cyberattack on its Change Healthcare unit.

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STAT+: Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules

STAT

WASHINGTON – In the last decade, Americans have been sickened by salmonella from cucumbers, listeria from Mexican-style cheese, and E. coli from romaine lettuce. Now, it would seem that Washington is finally getting serious about making sure the Food and Drug Administration has the power to promptly investigate and respond to foodborne outbreaks.

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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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House to discuss national data privacy bill with implications for healthcare

Fierce Healthcare

The House Energy & Commerce subcommittee on innovation will hold a hearing Wednesday to discuss data privacy and the protection of kids online. | The House Energy & Commerce Committee holds a legislative hearing to discuss a slate of privacy and online safety bills Wednesday, one of which would give consumers more control over health data collected by apps and big tech.

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Opinion: Autism doesn’t discriminate. Autism research shouldn’t either

STAT

The face of autism was once predominantly white. No longer. The Centers for Disease Control and Prevention reported last year that the prevalence of autism across all racial and ethnic groups is reaching parity. Among 8-year-olds in particular, autism was more commonly identified among Black, Hispanic and Asian American/Pacific Islander children than among their white counterparts for the first time ever.

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More Trending

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Biden administration announces new partnership with 50 countries to stifle future pandemics

STAT

WASHINGTON — President Joe Biden’s administration will help 50 countries identify and respond to infectious diseases, with the goal of preventing pandemics like the Covid-19 outbreak  that suddenly  halted normal life  around the globe in 2020. U.S. government officials will offer support in the countries,  most of them located in Africa and Asia , to develop better testing, surveillance, communication, and preparedness for such outbreaks  in those countrie

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Study Details Benefits, Therapeutic Effects of Medical Marijuana on Patients’ Quality of Life

Pharmacy Times

The study is the first of 5 studies co-published by AYR Wellness and LECOM and showcases improvements in physical, social, and mental well-being with minimal AEs.

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Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

Fierce Pharma

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.

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U.S. to set limits on silica exposure first recommended half a century ago

STAT

Most people know silica as the mysterious contents of desiccation packets found in vitamin bottles, high-end leather purses, clothing, and other items. But for miners and other stone cutters, silica is a serious health hazard, and new rules announced on Tuesday by a U.S. government agency set strict limits on how much of the mineral they can be exposed to.

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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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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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STAT+: Intra-Cellular reports positive results in depression study aimed at expanding use of antipsychotic medicine

STAT

Intra-Cellular Therapies reported positive results Tuesday from a late-stage clinical trial seeking to expand the use of its antipsychotic medicine Caplyta to patients with major depressive disorder. In the Phase 3 study, Caplyta reduced depressive symptoms by 4.9 points compared to a placebo on the Montgomery-Asberg Depression Rating Scale (MADRS), a widely used, clinician-rated measure of depression severity.

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With Vyvgart 'firing' in myasthenia gravis, argenx lays launch plans for next potential autoimmune approval: CEO

Fierce Pharma

Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.

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‘Stiffness’ of cells could give early warning of cancer

pharmaphorum

Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.

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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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Opinion: Practicing medicine at a predominantly Black institution gave me the gift I didn’t realize I needed

STAT

“You have a big voice, Dr. Grubbs,” the clinic manager said. I flinched. The last time I heard similar words, they were part of a common refrain that I had encountered often. “You’re too direct.” “Too outspoken.” “Intimidating.” Peers who looked like me encouraged me to put my head down, make myself smaller, endure — and never, ever call out racism.

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Judge Rules in Favor of Eli Lilly on Insulin Pricing Settlement

Drug Topics

With the judge’s failure to approve a settlement class, a $13.5 million settlement against Eli Lilly was called off.

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STAT+: UnitedHealth reaffirms financial outlook despite up to $1.6 billion hit from Change Healthcare cyberattack

STAT

Hospitals and medical groups say they’re still reeling from the effects of the cyberattack on a UnitedHealth Group subsidiary, but the massive company at the center of the debacle has so far emerged largely unscathed, with executives on Tuesday praising its strength and resilience. The almost $8 billion UnitedHealth made on operations in the first three months of 2024 was roughly the same as the prior-year period.

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GSK trails after Pfizer in 5-in-1 meningococcal vaccine race

pharmaphorum

FDA starts review of GSK’s 5-in-1 meningitis vaccine, cueing up a decision early next year, as it tries to chase down Pfizer's recently-approved Penbraya

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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

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Biohaven’s data delay degrades stock price

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! Today, we dig into Biohaven’s plans and see Humira biosimilar prescriptions shoot up.

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How Individuals are Committing E-Prescription Fraud

Drug Topics

The DEA informed community pharmacists on e-prescribing fraud and measures necessary to detect it.

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Boehringer says R&D pipeline is the best in its long history

pharmaphorum

Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030

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OTC Product Roundup: Allergies

Drug Topics

April showers might bring May flowers, but for some, the month also brings the return of allergy woes. This spring, breathe easy with these OTC allergy product recommendations.

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April Is Stress Awareness Month: A Little Humbling Self-Awareness May Go a Long Way

Pharmacy Times

The campaign for National Stress Awareness Month in April is under way.

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The Catalyst Connect 2024 Survival Guide

PioneerRx

It’s the most wonderful time of year for PioneerRx. Catalyst Connect 2024 is rapidly approaching, where pharmacists and other healthcare professionals.

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STAT+: Pharmalittle: We’re reading about CVS and Humira biosimilars, Schumer’s broken insulin promise, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are currently enveloping the placid Pharmalot campus, where the official mascots are snoozing cozily in their respective corners and the usual din of motor cars is nowhere to be heard. So this calls for a celebratory cup of stimulation. Our choice today is the oh-so tasty hazelnut mocha.

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Identifying and Screening for Hepatic Encephalopathy Risk Factors

Pharmacy Times

Arun Jesudian, MD; Ralph J. Riello, PharmD, BCPS, and Chas McCormick, RPh, MBA, delve into the complexities of hepatic encephalopathy, exploring the various risk factors that contribute to its development, such as alcohol-induced cirrhosis, sarcopenia, CNS medications, opioids, and other potential triggers.

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GLP-1 Use Not Associated With Increased Thyroid Cancer Risk

Drug Topics

A study from the Karolinska Institutet found that 76 out of 145410 patients treated with a GLP-1 developed thyroid cancer during nearly 4 years of follow-up.

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STAT+: A new PIPE lawsuit challenges the fairness of sharing confidential, stock-moving information

STAT

The fairness of PIPEs, particularly the preferential sharing of confidential, stock-moving information, is now a legal question. A shareholder is suing Taysha Gene Therapies insiders and a group of health care investment firms for allegedly enriching themselves in a $150 million PIPE transaction that involved delaying the public disclosure of positive results from a gene therapy clinical trial.

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FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine

Drug Topics

The company’s investigational ABCWY vaccine candidate will be reviewed by the FDA by February 14, 2025.

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Intra-Cellular sets up $500m offer on Caplyta depression win

pharmaphorum

Shares in Intra-Cellular Therapies rose after it reported Caplyta was effective for major depressive disorder (MDD), in a phase 3 trial.

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Norgine seeks approval for high-risk neuroblastoma treatment

Pharmaceutical Technology

Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).

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Semaglutide's New Indication Highlights Growing Role of GLP-1 Receptor Agonists

Pharmacy Times

The latest FDA approval paves the way for expanded use of GLP-1 receptor agonists in patients without diabetes.

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Qinecsa Solutions acquires Insife to strengthen pharmacovigilance technology

Outsourcing Pharma

Qinecsa Solutions (Qinecsa), a lead company in technology-driven end-to-end pharmacovigilance solutions has announced its acquisition of Insife ApS (Insife), a Danish-based firm specializing in innovative pharmacovigilance platforms.

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