Tue.Nov 19, 2024

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Medication Optimization Needed for Patients with Long COVID

Drug Topics

Investigators said there is an imperative to optimize medication utilization and explore the consequences of medication burden on treatment outcomes in patients with long COVID.

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Providers, payers focused on initial 'quick wins' for AI with plans to grow investment: survey

Fierce Healthcare

More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds. | More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds.

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The many legal fronts of RFK Jr.’s fight against vaccines

STAT

Robert F. Kennedy Jr. took leave as chairman of Children’s Health Defense, a nonprofit known for spreading doubt about vaccines, to run for president last year. But he is still fighting in court alongside the group, putting him in an unusual position for someone nominated as Secretary of Health and Human Services.   If confirmed by the Senate, Kennedy will have power to guide the agencies he oversees toward his priorities.

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FDA advisory committee to roll up sleeves on generative AI

Fierce Healthcare

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. | The FDA seeks advice on regulatory challenges it has identified for generative AI used in medical devices, which include uncertainty about the foundation model, hallucinations and the ability to define intended use.

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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: The FDA’s risky action on compounding weight loss drugs

STAT

When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.

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Community Pharmacies Must Diversify Their Revenue Streams to Survive in Today’s Landscape

Drug Topics

Drug Topics talked with Kelly Malkamaki, pharmacist, former independent community pharmacy owner, and senior product pharmacy analyst at AssureCare, about how community pharmacies can continue to thrive with decreased medication reimbursement rates.

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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Pain After Traumatic Injury Worse for Younger Adults Than Those 65 and Over

Drug Topics

Researchers aimed to determine the frequency of pain assessments and the extent of pain scores by age for patients undergoing traumatic surgery.

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Payer Roundup—CVS insider trading scandal; DOJ closely examining PBMs

Fierce Healthcare

Below is a roundup of payer-centric news headlines you may have missed during the month of November 2024. | In this month's payer roundup, a man was charged with insider trading for purchasing Oak Street Health stock before CVS made public the acquisition, the DOJ is honing in on pharmacy benefit managers and OIG found Medicare improperly paid acute-care hospitals by $190 million.

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Over Half of US Population Concerned About Prescription Drug Access, Prices

Drug Topics

Wolters Kluwer Health conducted a survey of just over 1000 respondents to get US adults’ feelings about notable trends in the pharmacy industry.

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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 Grants Fast Track Designation to Potential Gene Therapy for Osteoarthritis of the Knee

Pharmacy Times

GNSC-001 is a first-in-class gene therapy designed to offer long-term relief of musculoskeletal diseases such as osteoarthritis.

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STAT+: Merck says study of under-the-skin version of Keytruda, a bid to extend the drug’s sales, succeeded

STAT

Merck said a new formulation of the best-selling drug, Keytruda, appears to deliver similar blood levels of the medicine when it is given as a shot as when it is given intravenously. For Merck, the new under-the-skin, or subcutaneous, formulation of Keytruda could represent a major way of holding on to a larger share of Keytruda’s $25 billion in annual sales than would otherwise occur when the medicine’s U.S. patent expires in 2028.

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England's NICE turns down cancer drug Enhertu—again—amid pricing stalemate with AZ, Daiichi Sankyo

Fierce Pharma

Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s | Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.

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Spread of Seasonal Flu Returns to Pre-Pandemic Levels After End of COVID-19 Global Emergency

Pharmacy Times

Increased global capacity for surveillance could help monitor seasonal influenza to reduce the risk of vaccine mismatch and inform effective interventions.

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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+: In first meeting of FDA’s digital health advisory committee, generative AI is up for debate

STAT

Robert Califf has made no secret of the Food and Drug Administration’s struggles to regulate generative AI. Large language models and their application to health care “provide a massive example of a technology with novel needs,” FDA commissioner Califf said in an address earlier this year to the Coalition for Health AI.  This week, the agency will turn toward that challenge, focusing the first-ever meeting of its Digital Health Advisory Committee on the question of whet

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Researchers Assess Incidence of Shingles Vaccination Among Individuals with Asthma

Pharmacy Times

An increase of shingles vaccination was reported among individuals with asthma.

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A win for Apellis, a setback for Astellas

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Lots today from the American Heart Association’s annual meeting, plus former National Cancer Institute chief Ned Sharpless launches a new biotech called Jupiter.

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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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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+: Pharma still ‘falling short’ in providing access to low- and middle-income countries, analysis finds

STAT

Although more pharmaceutical companies are tailoring their business models to focus on low-income countries, a new analysis finds that overall industry efforts remain limited and patient access continues to suffer as a result. Notably, momentum has stalled in reaching licensing deals that are designed to make lower-cost generic drugs available in parts of the world where brand-name medicines are unaffordable, and few companies have pursued technology transfer agreements.

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Rite Aid Pharmacist’s Exploration of Immunization, Clinical Programming

Drug Topics

Adam J. James, PharmD, joined Drug Topics to discuss his career journey as a chain pharmacist.

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STAT+: Pharmalittle: We’re reading about a key Merck drug trial, cheap Wegovy in China, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are wafting over the Pharmalot campus, where the official mascots are snoozing after foraging for their breakfast. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is Mexican cinnamon.

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GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

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J&J plots filings after psoriasis drug clears phase 3 test

pharmaphorum

Johnson & Johnson has moved a step closer to filing a potential first-in-class therapy for psoriasis after the drug hit the mark in a phase 3 trial

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Outpatient Transplant and CAR T-Cell Therapy: A Paradigm Shift in Care Delivery

Pharmacy Times

Outpatient models are emerging as feasible alternatives to traditional inpatient care, offering potential benefits such as reduced hospitalization, improved social well-being, and cost savings.

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With patent settlement, BeiGene defends blockbuster Brukinsa from MSN's generic threat until 2037

Fierce Pharma

As BeiGene works to grow the reach of its cancer offerings, the company inked a patent settlement with MSN over its star medicine Brukinsa.

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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

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Advancing Pharmacogenomics Education: Standardization and Opportunities in Pharmacy

Pharmacy Times

Christine Formea, PharmD, MHI, BCPS, FCCP, FASHP, discusses the need for standardized pharmacogenomics education in pharmacy, highlighting opportunities for collaboration, professional growth, and integration of key competencies across curricula to advance the profession.

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An emerging cyberthreat: vishing

Fierce Healthcare

Cyberattacks against healthcare organizations are becoming increasingly sophisticated, with new threats constantly emerging. | This week on "Podnosis," we explore the rise of voice phishing, or vishing, where cybercriminals use AI to mimic voices and breach sensitive healthcare data.

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FDA Grants Fast Track Designation to VAD044 for Treatment of Adults With HHT

Pharmacy Times

Clinical trial analysis results studying VAD-44 in patients with hereditary hemorrhagic telangiectasia (HTT) will be presented at the 2024 American Society of Hematology Annual Meeting & Exposition.

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Americare taps FeelBetter to tackle polypharmacy risks for patients in long-term care

Fierce Healthcare

FeelBetter, a startup that launched six years ago, is expanding its AI-based medication management platform into long-term care through a partnership with Americare. | FeelBetter, a startup that launched six years ago, is expanding its AI-based medication management platform into long-term care through a partnership with Americare.

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Eating Problems, Diabetes Distress Associated with Worse Time-in-Range

Drug Topics

Patients with type 2 diabetes who had eating problems and higher levels of diabetes distress had worse time-in-range.

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Provide Counseling About OTC Blood Glucose Tools

Pharmacy Times

Pharmacists can increase awareness about the value of monitoring glucose and the proper use of nonprescription blood glucose meters and continuous glucose monitors.

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