Mon.Jun 10, 2024

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Cannabis to Treat Cancer: Younger Populations Reluctant to Disclose as Overall Use Becomes More Accepted

Drug Topics

Researchers addressed the use of cannabis to treat cancer symptoms in rural and urban areas, as well as patients’ comfortability discussing it with their providers.

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Study Finds Alterations in Functional Connectivity of Brain Regions in Adolescents With Internet Addiction

Pharmacy Times

The authors noted that these networks have a significant role in intellectual ability, physical coordination, working memory, emotional processing, and overall mental health.

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Moderna: Combination COVID-19–Flu Vaccine Trial Meets Primary Endpoints

Drug Topics

The vaccine, mRNA-1083, elicited noninferior responses vs individual COVID-19 and flu vaccinations.

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Millions fewer people may need statins, a new study suggests. But guidelines have yet to agree

STAT

It’s a familiar scene for patients during a routine primary care visit. The doctor scans blood test results, notes high cholesterol flagged by a standard calculator to assess risk of heart attack or stroke, then decides — and ideally discusses — whether to recommend taking a statin to cut the risk over time. That conversation may happen less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribin

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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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Microsoft rolls out program to help rural hospitals defend against cyberattacks

Fierce Healthcare

Microsoft will offer nonprofit pricing and discounts for its security products optimized for smaller organizations, providing up to a 75% discount.

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STAT+: Moderna says data show its combination Covid-flu vaccine generates a strong immune response

STAT

Moderna announced Monday that, in a Phase 3 clinical trial, its combination Covid-19 and influenza vaccine generated stronger immune responses in older adults than individual vaccines that target those viruses. The findings, disclosed in a press release, suggest the company may be on track to bring a combination flu and Covid vaccine to the market, potentially as early as autumn 2025.

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STAT+: FDA advisers unanimously recommend approval of Eli Lilly’s Alzheimer’s disease treatment

STAT

Advisers to the Food and Drug Administration voted 11-0 on Monday to recommend the approval of a drug for early Alzheimer’s disease made by Eli Lilly — ruling that the treatment’s ability to slow the cognitive decline in patients outweighed its safety risks. The unanimous outcome of the daylong advisory panel was the best-case scenario for Lilly, making it likely that the FDA will approve the drug, called donanemab, for a broad population of people diagnosed with mild cognit

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What can pharma companies do to quicken the pace of digital disruption?

pharmaphorum

Discover how pharmaceutical companies can leverage digital technologies to accelerate innovation and disrupt the industry. Learn about regulatory considerations and engagement with healthcare professionals (HCPs) for successful digital transformation.

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Lab experiment shows exactly how heat waves can put hearts into ‘oxygen debt’

STAT

When temperatures soar, so do heart attacks. Now, a lab experiment explains just how temperatures climbing into Fahrenheit’s three-digits can cause ischemia and potential heart attacks, all while international efforts to limit long-term warming seem like they’re running out of time. The experiment, which gradually exposed participants to higher temperatures, showed that exposure to heat even while resting made participants’ hearts work harder, ramping up blood flow through t

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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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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Opinion: Curing rare childhood diseases will falter unless Congress steps up

STAT

When our son Peter was diagnosed with an ultra-rare form of muscular dystrophy at the age of 10, the first question we asked was: Is there a treatment? The answer was no. By the time our daughter Maggie, then just 6, received the same diagnosis, that answer hadn’t changed. We soon learned that our situation is tragically common. As many as 30 million Americans live with some type of rare disease, defined as a disease that affects fewer than 200,000 people.

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FDA Grants Emergency Use Authorization for 4-in-1 Respiratory Diagnostic Test

Pharmacy Times

The 4-in-1 respiratory diagnostic test is either a single nasopharyngeal or anterior nasal swab that can confirm or rule out SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus with a single test.

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STAT+: Watch: How Harvard researchers boosted an ALS patient’s independence with a box and a balloon

STAT

John Goodson practiced medicine for almost 50 years at Massachusetts General Hospital in Boston. As a primary care physician, he saw thousands of patients and ailments, so when he struggled to raise the front of his foot in 2021, he felt a knowing dread. “As a physician, I had made the diagnosis of a patient with ALS and developed a close relationship and followed this patient right through to his death at home,” said Goodson.

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Discussing the FDA Panel’s Rejection of MDMA-Assisted Therapy for PTSD

Drug Topics

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, talks about some of the problems he saw during the Psychopharmacologic Drugs Advisory Committee meeting.

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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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STAT+: Medical device trials still don’t enroll enough women, study finds

STAT

Women have always been underrepresented in medical research. A new study reveals that not much has changed, especially when it comes to tests of cardiovascular devices.  In a paper published in JAMA Internal Medicine on Monday, researchers found that the percentage of women represented in high-risk medical device trials did not increase from 2010 to 2020.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

The FDA Law Blog

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

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STAT+: Humana scores a win in a Medicare Advantage case

STAT

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday. Always watch the courts There’s a joke that all reporters essentially are legal reporters. But it’s kind of true, especially within the health care beat. Congress can’t get anything done, and the federal agencies have their routine rule-making powers.

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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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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: How faith leaders like me can help address America’s obesity epidemic

STAT

Many factors drive America’s obesity epidemic — environment, genetics, eating habits, and more. Solving the problem isn’t solely about getting people to lose weight. What’s also needed is overcoming the stigma and systemic bias directed at people living with obesity. Most people are dealing with a world of emotional stress.

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GSK, attempting to stage Blenrep comeback, bids adieu to combo studies with SpringWorks' Ogsiveo

Fierce Pharma

Despite the recent approval of SpringWorks Therapeutics’ Ogsiveo, GSK is calling it quits on prior plans to wed the Pfizer spinout’s drug with its withdrawn cancer med Blenrep. | SpringWorks has received a notice of termination on an amended collaboration and licensing deal with GSK from 2022. Under the updated pact, GSK and SpringWorks were working together to develop and potentially market combinations of Blenrep and Ogsiveo in multiple myeloma.

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The biotech news you missed from the weekend

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Lots on vaccines this morning: Moderna says its combination shot for Covid and flu works well, and might help improve uptake in the broader population. And the FDA just cleared GSK’s RSV vaccine for younger at-risk adults.

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Last places on FDA START rare disease programme filled

pharmaphorum

The last three slots for projects that will be included in the FDA’s new programme to accelerate the development of therapies for rare diseases have been taken by Moderna, Myrtelle, and Calico Life Sciences.

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FDA Approves Expanded Age Indication for Arexvy RSV Vaccine

Pharmacy Times

The expanded indication is for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in adults aged 50 through 59 years who are at an increased risk.

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The best diet for hiatal hernias

The Checkup by Singlecare

Hiatal hernias occur when part of your stomach pushes up through the hiatus—the spot in your body where the esophagus passes from the chest cavity through the diaphragm into your abdomen. This condition makes it easier for stomach acid to flow up into the esophagus, causing heartburn and acid reflux—which can lead to gastroesophageal reflux disease (GERD).

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FDA Approves Tirbanibulin for Actinic Keratosis on Expanded Area of Face or Scalp

Pharmacy Times

The new approval increases the previous dosing for surface area treatment from 25 cm2 to up to 100 cm2.

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FDA OKs wider use of Almirall’s actinic keratosis drug

pharmaphorum

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri. First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can be a precursor to skin cancer.

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Early Diagnosis and Intervention in Asthma, COPD Reduces Health Care Utilization

Pharmacy Times

Patients with undiagnosed asthma or COPD who received usual care from their primary providers were more likely to visit the hospital or specialists because of respiratory illness.

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Pharma Pulse 6/10/24: Sustainability in Clinical Trials, Merck Bets on AI Drug-Design Partnerships & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Exploring the Expansive Role of AI in Clinical Pharmacy: Insights From ASHP Pharmacy Futures 2024

Pharmacy Times

The impact of artificial intelligence (AI) on health care is growing, from diagnostics to drug discovery.

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STAT+: Pharmalittle: We’re reading about a Moderna Covid-flu vaccine, a paused Pfizer study, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the coffee kettle to brew some cups of stimulation.

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The Disruptive Impact of AI in Health Care

Pharmacy Times

Kenneth A. Richman, PhD, discusses the disruptive nature of artificial intelligence (AI) in health care, highlighting both its transformative potential and the ethical considerations of governability and sustainability in its implementation.

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Innovative radioligand manufacturing facility inaugurated

European Pharmaceutical Review

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. Orano Med (a subsidiary of the Orano Group)’s ATLab (Alpha Therapy Laboratory) facility in Brownsburg, near Indianapolis, Indiana, US, is set to help address the production and supply challenges of lead-212 radioligand therapies.

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Boehringer, Lilly face off in MASH at EASL

pharmaphorum

Eli Lilly's tirzepatide and Boehringer Ingelheim's survodutide grab the spotlight at EASL with new phase 2 data in metabolic dysfunction-associated steatohepatitis (MASH)

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