Sat.Dec 14, 2024 - Fri.Dec 20, 2024

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First Severe Case of Bird Flu Detected in Louisiana

Drug Topics

Recent upticks of the bird flu virus in both dairy cattle and humans have also led to a state of emergency in California.

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FDA issues warnings to GLP-1 compounders

The Checkup by Singlecare

Originally approved to help people with Type 2 diabetes, the class of medications known as GLP-1 agonists and dual GIP/GLP-1s quickly acquired a reputation for helping people shed stubborn pounds. As a result, the use of medications like Ozempic , Wegovy , Zepbound , Rybelsus , and Mounjaro has skyrocketed, as people turned to these medications to help them lose weightcausing drug shortages and creating a market for compounded versions of these brand-name drugs.

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Top tips for effective digital transformation and closed loop medicines management

Hospital Pharmacy Europe

S erious adverse drug events are unfortunately common in hospitals and can occur across all stages of the medication delivery process. Here, Francine de Stoppelaar shares her top tips for implementing effective closed loop medicines management systems as part of a hospitals digital transformation journey to enhance patient care, reduce expenditures and build a sustainable future for healthcare.

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STAT+: Feds accuse CVS of filling ‘thousands’ of illicit opioid prescriptions

STAT

CVS Health was accused of contributing to a nationwide epidemic of opioid addiction and overdose by filling illegal opioid prescriptions and billing federal health insurance programs, according to a lawsuit unsealed Wednesday by the U.S. Department of Justice. The lawsuit alleged that, since October 2013, CVS knowingly filled prescriptions for “dangerous and excessive quantities” of controlled substances that lacked a legitimate medical purpose, were not valid, and were not issued

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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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Adopting AI for R&D in 2025 – what needs to be addressed?

European Pharmaceutical Review

With the life sciences and healthcare sectors increasing integration of artificial intelligence (AI) into their infrastructure, according to research by GlobalData, one-third of healthcare professionals considered data privacy is the primary obstacle, citing challenges such as robust safeguards, workflow integration, and stakeholder acceptance [being] essential to ensure AIs ethical implementation and long-term success. 1 These concerns are held alongside the promise of this technology and its p

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Does Mounjaro need to be refrigerated?

The Checkup by Singlecare

Like semaglutide, Mounjaro (tirzepatide) is a once-a-week injectable medication that is FDA approved for helping manage blood sugar levels in those with Type 2 diabetes. It mimics two gastrointestinal hormones: glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP). So, the active ingredient can also be prescribed for weight loss or obesity, combined with diet and exercise, under its licensed brand name Zepbound.

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STAT+: Health plan formularies lowered barriers to fair access to some drugs, analysis finds

STAT

Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found. Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2)

The FDA Law Blog

By Richard A. Lewis, Senior Regulatory Device & Biologics Expert & James E. Valentine We recently published the first part of our review of FDAs draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Questions and Answers Guidance (see previous coverage here ). In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content.

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If Zyrtec doesn’t work what should I try?

The Checkup by Singlecare

Zyrtec ( cetirizine ) is an over-the-counter ( OTC ) medication and antihistamine used to treat allergy symptoms. Signs of allergic rhinitis, hay fever , and seasonal allergies include sneezing , runny nose , stuffy nose , swollen nasal passages , itchy eyes , and watery eyes. These conditions are similar to nonallergic rhinitis in that they cause the same symptoms, but they are different in that the latter isnt caused by contact with an allergen.

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After studies flag possible link between Novo's Ozempic and rare eye disorder, Danish agency calls for probe

Fierce Pharma

Its not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisks diabetes superstar Ozempic and blindness? | After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

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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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‘I want help’: Behind bars, pleas for addiction medications often go nowhere

STAT

James Mannion knew what he needed. For nine months, while incarcerated in a county jail in Portland, Maine, he pleaded for a medication called buprenorphine. Mannion, a barber, recreational fisherman, and father of two, was once a regular heroin user, but had used the medication to eliminate the cravings and withdrawal he experienced whenever he tried to quit opioids cold turkey.

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MHRA Grants Marketing Authorisation for LEO Pharma’s Anzupgo® ▼(delgocitinib) cream in Great Britain

Pharmafile

3 December 2024 Berkshire, UK, LEO Pharma, a global leader in medical dermatology, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for delgocitinib cream for the treatment of adult patients with moderate to severe Chronic Hand Eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.

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Can you drink while taking metoprolol?

The Checkup by Singlecare

Mixing alcohol with metoprolol can come with various side effects, some of which can be serious. Many people take metoprolol, either as metoprolol tartrate or metoprolol succinate , to help manage high blood pressure and heart conditions. If youre considering drinking alcohol while taking this prescription drug, you should know the possible risks. For some people who know how they react to the medication and alcohol, drinking in moderation may be doable.

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Advocate Health Care unveils $1B investment for expansion on Chicago's South Side

Fierce Healthcare

Advocate Health Care unveiled plans this week to spend $1 billion to improve healthcare services on Chicago's South Side, including building a brand new hospital, 10 neighborhood care locations, ex | Advocate Health Care unveiled plans this week to spend $1 billion to improve healthcare services on Chicago's South Side, including building a brand new hospital, 10 neighborhood care locations, expanded outpatient services and workforce development initiatives.

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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+: Next-gen obesity treatment from Novo Nordisk misses mark in pivotal trial

STAT

Novo Nordisk’s next-generation obesity candidate led patients to lose a substantial amount of weight in a pivotal study but fell short of expectations, results that cast into doubt the future competitiveness of the company in the booming weight loss market. The treatment, called CagriSema, led patients to lose 20% of their weight at 68 weeks in a late-stage study when looking at all participants, including those who dropped out, Novo said Friday.

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NICE recommendation for KORSERDU®▼ (elacestrant) marks ‘step-change’ in the treatment of ESR1-mutated metastatic breast cancer

Pharmafile

19 December 2024 London, UK, Menarini Stemline UK today welcomed final draft guidance from the National Institute for Health and Care Excellence(NICE) recommending use of the first tailored treatment for locally advanced and metastatic breast cancer that has acquired mutations in the ESR1gene, estimated to benefit around 1,000 patients in England and Wales each […] The post NICE recommendation for KORSERDU(elacestrant) marks step-change in the treatment of ESR1-mutated metastatic breast c

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What to know about Linzess and coffee

The Checkup by Singlecare

Tens of millions of people start their day with coffee without a second thoughtmany even find it difficult to have any thoughts at all before their first cup. But if youre taking prescription drugs on a regular basis, such as Linzess (the brand name for linaclotide), you may be wondering if you need to rethink your morning joe. Linzess is an oral medication that is approved by the Food and Drug Administration for the treatment of irritable bowel syndrome with constipation (IBS-C) as well as chro

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Navina, Agilon Health team up on clinical insights for primary care providers in at-risk contracts

Fierce Healthcare

Navina, a platform turning patient data into clinical insights, is teaming up with Agilon Health to help deliver additional insights to primary care docs at the point of care. | Navinas AI-driven platform helps providers get a complete picture of their patients health by pulling on structured and unstructured patient data from places like the EHR, health information exchanges and claims data.

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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+: Pharmalittle: We’re reading about a Vertex pain drug, the Feds suing CVS over opioids, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and chilly breezes are wafting across 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 blueberry cobbler.

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PBM Reform Pulled Back in Late Change to Spending Package

Drug Topics

With pressure from the House GOP, expected PBM reform was not included in Congress end-of-year spending package.

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Can you eat oranges if you have diabetes?

The Checkup by Singlecare

Theres nothing like biting into a sun-kissed orange, its juice filling your mouth with the refreshing taste of citrus. But if youre a person living with diabetes , you may wonder what effect the sweet treat will have on your blood sugar. You probably know that managing your blood sugar levels means being mindful of your carbohydrate intake and the glycemic index of your foods.

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Telenutrition company Culina Health raises $7.9M series A

Fierce Healthcare

Culina Health, a telenutrition company, raised $7.9 million in a series A funding round led by Healthworx, the innovation and investment arm ofCareFirst BlueCross BlueShield, the co | Four year-old Culina Health has raised its series A funding round, led by Healthworx, the venture arm of CareFirst. The company seeks to normalize nutrition counseling and prove that a better diet lowers total cost of care.

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STAT+: House Republicans abandon PBM reform in push to keep government open

STAT

WASHINGTON — House Republicans have abandoned an effort to include reforms to pharmacy benefit managers in an end-of-year bill to fund the federal government. Congressional leaders had reached a deal to rein in prescription drug middlemen earlier this week, but the larger package it was tacked onto fell apart following backlash from conservatives and top advisers to President-elect Trump.

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Long-Awaited PBM Reform Included in Congress’ End-of-Year Spending Package

Drug Topics

The American Pharmacists Association announced the inclusion of pharmacist-backed PBM reform in Congress end of the year spending package.

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Tizanidine alternatives: What can I take instead of tizanidine?

The Checkup by Singlecare

Tizanidine is a generic prescription muscle relaxant available as brand-name Zanaflex, which is approved by the Food and Drug Administration (FDA) for treating spasticity , a condition in which muscles stiffen or tighten, preventing normal fluid movement. Tizanidine is also used off-label (for a non-FDA-approved use) for musculoskeletal pain. In addition, its sedative effects may offer relief to patients with insomnia caused by severe muscle spasms (but this benefit is also not FDA approved).

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Medical supply firm Medline confidentially files for potential blockbuster IPO in 2025

Fierce Healthcare

Medical equipment and supply manufacturer Medline Industries confidentially submitted plans for a proposed initial public offering, potentially setting the stage for a blockbuster public debut next | Medical equipment and supply manufacturer Medline Industries confidentially submitted plans for a proposed initial public offering, potentially setting the stage for a blockbuster public debut next year.

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STAT+: FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period

STAT

The Food and Drug Administration on Thursday confirmed that a shortage of Eli Lilly’s obesity drug tirzepatide has been resolved, a move that will soon put a stop to companies making cheaper copies of the injection. The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

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FDA Approves Tirzepatide for Obstructive Sleep Apnea in Patients with Obesity

Drug Topics

Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.

FDA
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A biotech’s race to tackle the most severe hepatitis

PharmaVoice

Bluejay Therapeutics is one of just a handful of companies developing treatments for hepatitis D.

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Treatment Advances for Alzheimer Disease Provide Hope

Pharmacy Times

New mechanisms of action are proving more effective than ever, offering slowed progression.

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STAT+: Congress nears deal to rein in PBMs after years of debate

STAT

WASHINGTON — After two years of haggling, Congress has nearly reached a deal to rein in the drug-industry middlemen known as pharmacy benefit managers. Lawmakers agreed to extend telehealth flexibilities, fund public health programs, and enact these major PBM changes as part of a government funding package they are planning to pass before the end of the year, according to four health care industry sources and two congressional aides.

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Pfizer Vaccine Reduces Risk of Long COVID in Pediatric Patients

Drug Topics

Authors concluded that that the benefit of the vaccine in preventing long COVID is due mainly to the fact it mitigates the risk of infection.

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Merck’s RSV antibody could soon paddle into the rough waters of a crowded market

PharmaVoice

A new antibody from Merck would join a market teeming with new entries, but plenty of regulatory and financial uncertainty.