Wed.Sep 11, 2024

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New Study Examines Potential of Oxytocin as Pain Management Adjunctive, Addiction Treatment

Drug Topics

The “cuddle hormone” plays a powerful role in human behavior and may be an additional option to treat pain and manage opioid addiction.

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How a government scientist is pushing to supersize research into ultra-processed foods

STAT

CHICAGO — The last place you might have expected Kevin Hall to make a plea for help was at a conference of scientists who work for global food conglomerates. After all, the government researcher is the leading scientific voice in the United States warning that a steady diet of these engineered products might be a crucial driver of the nation’s epidemic of overeating.

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From Opioids to Cannabis: The Impact of Cannabis Rescheduling on Pharmacy Revenue Streams

Pharmacy Times

The DEA will have a hearing in December 2024 regarding the potential reclassification of cannabis to Schedule III, which could significantly impact the regulatory environment for pharmacies and their involvement in the cannabis market.

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STAT+: FDA commissioner: Health systems have to ‘step up’ on AI regulation or will ‘end up holding the bag’

STAT

WELLESLEY, Mass. — Amid heated discussions on how artificial intelligence should be regulated and who should be involved in health care AI governance, the U.S. Food and Drug Administration commissioner said that health systems need to take a leading role. “I think there’s a lot of good reason for health systems to be concerned that if they don’t step up, they’re going to end up holding the bag on liability when these algorithms go wrong,” said Robert Cal

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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 Orphan Drug Designation to AISA-021 for Systemic Sclerosis

Pharmacy Times

The company also submitted data from the ongoing phase 2 study, demonstrating the improvements of the investigational drug for symptoms of overall disease severity.

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Opinion: Why so many patients are confused about CPR and do-not-resuscitate orders

STAT

When a patient is admitted to the hospital in the U.S., there’s a standard question physicians like me are supposed to ask: “If your heart stops beating, do you want us to do CPR?” On the surface, this may seem like a mechanic asking a customer, “If your car stalls, do you want us to jumpstart the engine?” Who would say no to this, especially in a hospital?

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Nationwide hospital mortality risk fell as acuity, volumes rose, report finds

Fierce Healthcare

Hospital patients’ risk of death has fallen substantially since the COVID-19 pandemic and the months preceding it, even as hospitals are treating more and sicker patients, according to a new report | An analysis of 715 hospitals' patient safety metrics showed that patients hospitalized in Q1 2024 were about 22% more likely to survive as compared to Q4 2019, after adjusting for illness severity.

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Five takeaways from Congress’ hearing on overhauling organ transplant system

STAT

WASHINGTON — On Wednesday, two transplant doctors, one watchdog and a nephrologist-turned-advocate sat before members of Congress to talk about the nation’s troubled organ transplant system. For over two hours the House Subcommittee on Oversight and Investigations ran through allegations of inefficiency, inertia, negligence and corruption in the groups charged with coordinating transplants throughout the U.S.

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VLA1553 Chikungunya Virus Vaccine Shows Antibody Persistence Up to 2 Years Following Administration

Pharmacy Times

The investigators of the phase 3b trial (NCT04838444) will continue to follow up with patients for up to 10 years.

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STAT+: FDA scolds AbbVie over ‘misleading’ TV ad for a migraine pill featuring Serena Williams

STAT

The U.S. Food and Drug Administration has scolded AbbVie for making false and misleading claims about a  TV ad about a migraine pill that features Serena Williams, the third time this year the agency has taken a major pharmaceutical company to task for its marketing. The agency is upset with Abbvie for a couple of reasons. First, the TV spot suggests that the medication, which is called Ubrelvy, will “provide a greater treatment benefit to patients suffering from migraine headache th

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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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Advances With Various Therapies Targeting DLL3 in Lung Neuroendocrine Tumors

Pharmacy Times

An overview of the latest developments in targeting DLL3 in lung neuroendocrine tumors were presented at the 2024 World Conference on Lung Cancer.

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STAT+: ‘Sarepta’s like a curse on me’: FDA commissioner dismisses controversy over Elevidys

STAT

WELLESLEY, Mass. — At an event with journalists Tuesday outside of Boston, U.S. Food and Drug Administration commissioner Robert Califf dismissed criticism that the agency is lowering standards for new drug approvals, even when clinical trials fail. This summer, the FDA expanded Sarepta Therapeutics’ accelerated approval for the Duchenne muscular dystrophy gene therapy Elevidys , despite the drug failing its Phase 3 trial.

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Tocilizumab Effective in Patients With Inadequate Response to Intravenous Immunoglobulin for MOGAD

Pharmacy Times

Tocilizumab reduced relapses in 4 patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

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Blood cell counts have unfairly kept Black and Middle Eastern people from clinical trials, study says

STAT

One of the most important measurements for cancer patients is the neutrophil count. Certain cancer therapies like chemotherapy can be harsh on these white blood cells, so cancer patients need their neutrophil count to be in a given range when undergoing those treatments or before enrolling in particular clinical trials. That can be a problem for people who have a natural blood variation called the Duffy-null phenotype.

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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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50 Years of Progress: Unlocking Stem Cell Transplantation for All Patients

Pharmacy Times

This year the world’s first stem cell register celebrates its 50th anniversary.

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Meet MILTON, AZ's AI that can predict 1,000+ diseases

pharmaphorum

A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis

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GAO: A look at cost-sharing for behavioral health in traditional Medicare, MA

Fierce Healthcare

Enrollees in both traditional Medicare and Medicare Advantage have cost-sharing obligations for behavioral health services, a GAO report shows.

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Excess Abdominal Fat May Contribute to Chronic Musculoskeletal Pain

Drug Topics

“Reducing abdominal adiposity may be considered a target for chronic pain management, particularly in those with pain in multiple sites and widespread pain,” wrote investigators.

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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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ERISA proponents roll out laundry list of desired improvements

Fierce Healthcare

More than 50 years after the Employee Retirement Income Security Act (ERISA) was signed into law, a House hearing Sept. 10 delved into ways to protect and improve the legislation. | A House hearing celebrating the 50th anniversary of ERISA put a spotlight on ways to bring down costs for employers and individuals.

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Understanding Medical Debt, Complexity of US Health Care System

Drug Topics

Researchers looked for a better understanding of medical debt and what type of role the US government plays in lessening the burden on patients and their health care costs.

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CommonSpirit opens Colorado hospital doors to Kaiser Permanente members, docs

Fierce Healthcare

More Kaiser Permanente members in Colorado will soon be able to visit CommonSpirit Health hospitals for their inpatient and emergency care, the nonprofit giants announced Tuesday. | Four of CommonSpirit Health's Metro Denver area hospitals will integrate Kaiser Permanente physicians and employees to provide care for its members. The nonprofit systems have a similar arrangement at five other hospitals elsewhere in the state.

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Thyroid Eye Disease Treatment Shows Positive Results in Phase 3 Trial

Drug Topics

Viridian Therapeutics also said it has completed enrollment for a second phase 3 trial of veligrotug, THRIVE-2, and expects topline data to be available by the end of this year.

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The benefits of ePI for patients and the planet

pharmaphorum

Discover the advantages of paperless medicine information for patients and the environment. Learn how electronic product information benefits both your health and the planet.

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Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc

Fierce Pharma

For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. The regulator specifically raised an eyebrow at the post-marketing trials Intercept has used in a bid to keep hold of the accelerated approval it won back in 2016.

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UK doctors sceptical of AI's role in treatment

pharmaphorum

One in two UK doctors would not use GenAI to treat patients, but there was more willingness to use it for diagnostic purposes, survey finds

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Prodrugs and patents: Enhancing therapy adherence and reducing side effects 

Pharmaceutical Technology

As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.

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Opinion: The surgeon general’s warning on parental mental health doesn’t go far enough

STAT

Surgeon General Vivek Murthy’s latest warning unearths concerning statistics about the mental health and well-being of American parents. These findings resonated with me deeply on two levels. First, I am a parent of three school-age children. Second, I am a trained therapist and head of behavioral health at a provider organization focused on caring for the most vulnerable members of our population — Medicaid members and those dually eligible for both Medicaid and Medicare.

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J&J’s Tremfya, following in Stelara’s footsteps, enters crowded ulcerative colitis arena with FDA nod

Fierce Pharma

Johnson & Johnson already has a major presence in the crowded inflammatory bowel disease (IBD) space with its popular Stelara. | Tremfya will enter the UC space as J&J’s older Stelara, which is approved to treat both forms of IBD, nears biosimilar competition and Inflation Reduction Act-mandated price concessions.

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Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control

The FDA Law Blog

By John W.M. Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API),

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Eli Lilly releases new data on weekly insulin

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Amycretin has some intriguing results in obesity Amycretin, an experimental Novo Nordisk obesity pill that targets both amylin and GLP-1 receptors, spurred significant weight loss in a Phase 1 study, the company announced yesterday.

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Pharma Pulse 9/11/24: Cutting-Edge Tech is Fast-Tracking the Future of Medicine, It’s the Business Model, Stupid. & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Innovative medicine production site inaugurated in France

European Pharmaceutical Review

Sanofi has inaugurated a new production unit in France which utilises a world-first modular concept. The site, Modulus, located in Neuville-sur-Saône (Rhône-Alpes), is supported by an investment of nearly €500 million and will produce Sanofi’s next vaccines and biologic drugs. Modulus can adapt to manufacture up to four vaccines simultaneously. Notably, reconfiguration of the technological platform (live attenuated viral vaccines, recombinant protein or messenger RNA vaccines, as well as treatme

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How the Big 3 PBMs Utilize Various Market Strategies

Drug Topics

To further understand PBM market concentration, researchers separately analyzed commercial insurance, Medicare Part D, and Medicaid managed care market strategies of the 3 biggest PBMs.