Fri.Nov 22, 2024

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H5N1 Bird Flu: A Slowly Looming Public Health Threat

Drug Topics

Public health and infectious disease experts offered their perspectives on the 2024 US bird flu outbreak and its potential of becoming a greater public health crisis.

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STAT+: BridgeBio wins FDA approval for heart disease drug

STAT

The Food and Drug Administration approved on Friday a new medicine from BridgeBio for patients with a progressive heart disease — the first new treatment for the condition in over five years and the company’s first significant commercial product. The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby.

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Chain Pharmacist Embracing Expanded Role in the Profession

Drug Topics

On the most recent episode of Over the Counter, James Rider, PharmD, joined Drug Topics to discuss his career journey as a chain pharmacist.

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Opinion: Why cancer advocates like me are leaving X

STAT

A version of this essay first appeared on Janet Freeman-Daily’s blog, Gray Connections. I’ve been living with and communicating about lung cancer for over 13 years. Since 2011, the year I was diagnosed, I’ve been active in one or more online lung cancer patient groups. Since 2012, I’ve been blogging and on social media, connecting with the lung cancer community and learning/sharing developments in cancer research.

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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 RAG-21 for Treatment of ALS

Pharmacy Times

If approved, RAG-21 can offer improved outcomes in patients with amyotrophic lateral sclerosis (ALS), particularly those with aggressive subtypes.

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Why whooping cough cases are spiking across the U.S.

STAT

Whooping cough cases are up sixfold from the same time last year in the U.S., affecting states ranging from Pennsylvania and New York on the East Coast to Wisconsin and Ohio in the Midwest and California and Washington out west. Experts say the spike in cases is likely a return to the pre-pandemic cycle , in which cases of the illness would ebb and flow about every five years.

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Opinion: I’m a vaccine activist — and I’m optimistic about the future right now

STAT

The current forecast for vaccine policy in the United States is, to put it mildly, stormy. With Robert F. Kennedy Jr. as the nominee for secretary of Health and Human Services and a slate of other names — including Mehmet Oz , Jay Bhattacharya, and Florida Surgeon General Joseph A. Ladapo — floated as possible appointees, public health advocates are rightly concerned about the future of evidence-based public health policies.

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No Association Between High-Dose NSAIDs, Hypertension in axSpA | ACR Convergence

Drug Topics

NSAIDS are typically the first line of treatment for axial spondyloarthritis.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Cervical Cancer Screening, HPV Vaccination Lacking In SLE | ACR Convergence

Drug Topics

Systemic lupus erythematosus is associated with a higher risk of cervical dysplasia due to the inflammatory nature of the disease.

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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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More beef in the gene editing space

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! Today, more beef in the gene editing space, with Prime Medicine’s CEO getting a little aggressive over patent disputes. Also, Novartis acquires a gene editing startup, and why patient advocates are migrating to Bluesky.

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Reproductive Health Counseling and Education Crucial for Women With Rheumatic Disease | ACR Convergence

Drug Topics

Despite an interest in services, a majority of women do not have these critical conversations with their health care providers.

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Decision to Receive Pneumococcal Vaccine Among Older Adults Is Multi-Factorial, Influenced by Multidimensional Interventions

Pharmacy Times

Commonly cited factors influencing uptake of pneumococcal vaccination included knowledge of pneumococcal disease and vaccine benefits, recommendations from health authorities, and perceived risk of infection.

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As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact

Fierce Pharma

As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact fkansteiner Fri, 11/22/2024 - 09:04

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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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Jazz gets first FDA nod for HER2 bispecific Ziihera

pharmaphorum

Jazz Pharma has claimed FDA approval for its HER2-directed bispecific antibody Ziihera as a treatment for biliary tract cancer

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STAT+: Sanofi plans to change payment terms for 340B hospitals

STAT

The battle over prescription drug discounts offered to hospitals under a federal program escalated as Sanofi became the third pharmaceutical company to disclose plans to change the way it will make payments. In a letter sent to hospitals and clinics on Friday, Sanofi indicated that certain hospitals covered by the 340B Drug Discount Program would receive credits for medicines ordered at full price from a wholesaler.

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Neurogene drops high-dose arm in Rett study after death

pharmaphorum

The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died

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Nonopioid Options to Manage Chronic Pain in Veterans | ACR Convergence

Drug Topics

Chronic pain is more prevalent—and more severe—in veterans compared with the general US population.

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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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Arrowhead Pharmaceuticals Submits FDA Application for Plozasiran in Familial Chylomicronemia Syndrome

Pharmacy Times

Familial chylomicronemia syndrome (FCS) currently has no FDA-approved treatment and is associated with an increased risk of acute pancreatitis.

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As J&J tries to wrap up talc litigation in the US, the company now faces class action in UK

Fierce Pharma

While Johnson & Johnson hopes to soon resolve more than 60,000 talc lawsuits with an $8 billion bankruptcy settlement in the United States, its baby power problems are only just beginning in th | While Johnson & Johnson hopes to soon resolve more than 60,000 talc lawsuits with an $8 billion bankruptcy settlement in the United States, its baby power problems are only just beginning in the U.K.

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Autism advocates respond to RFK Jr.; a trip to the nipple factory; a new water pollutant (don’t panic)

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. This week, a Nature paper shared a new method that can convert Teflon — and toxic “forever chemicals,” or PFAS — to harmless charcoal (and fluoride).

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Disconnect Between Adolescent, Caregiver Pain and Depression Symptoms in Rheumatic Diseases | ACR Convergence

Drug Topics

PROMIS scores demonstrated the disparities between reported pain and mental health outcomes.

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Oseltamivir May Shorten Hospital Stays for Children With the Flu

Pharmacy Times

Children with obesity, asthma, and gastrointestinal disease had longer durations of stays compared with children without comorbidities.

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Will Walgreens’ store closures derail its clinical trial aims?

PharmaVoice

Despite a plan to shutter 1,200 stores, the company’s chief clinical trials officer said the pharmacy juggernaut remains committed to drug research.

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After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

Fierce Pharma

For many biopharmas, it takes years of hard work to transition from being a clinical-stage drugmaker to a commercial one. Companies rarely want to make the shift back. | The pivot comes after the FDA issued a notice that the deficiencies in the company's approval bid for type 1 diabetes med Zynquista are too great to proceed for further discussion.

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Chutes & Ladders — CVS Health continues leadership shakeup; Providence appoints COO

Fierce Healthcare

Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. | Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please submit the good news—or the bad—from your shop, and we will feature it here at the end of each week.

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Women With Natural Menopause at a Later Age May Have an Increased Risk of Asthma

Pharmacy Times

Women aged 40 to 44 years at the time of natural menopause showed about a 30% decreased risk for asthma incidence.

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Trump selects surgeon and author Martin Makary for FDA commissioner post

Fierce Pharma

President-elect Donald Trump has put forward a formal pick for the top spot at the U.S. Food and Drug Administration. | President-elect Donald Trump has named Johns Hopkins surgeon and author Martin Makary, M.D., as his choice for FDA commissioner during his upcoming term.

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Final Thoughts

Pharmacy Times

The panel discussion concludes with final thoughts on the future landscape of newly diagnosed multiple myeloma.

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Who should not take Wegovy?

The Checkup by Singlecare

Wegovy (semaglutide) is a once-a-week injection meant to be used with a lower-calorie diet and exercise to help adults and children 12 years and older lose weight. Wegovy is approved by the Food and Drug Administration (FDA) for long-term weight management and reducing the risk of heart attack, stroke, and death in adults with heart disease and obesity.

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Skills Needed to Thrive in the Evolving Industry Landscape

Pharmaceutical Commerce

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, comments on the specific technical and soft skills that are critical in order for pharma leaders and frontline employees to excel in ever-changing industry landscape, while explaining why these skills are beneficial when it comes to being proactive in handling talent shortages.

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Is Ozempic a controlled substance?

The Checkup by Singlecare

Ozempic (semaglutide) has made its way into headlines and water-cooler conversations largely due to its off-label use for weight loss more than its approved use for Type 2 diabetes mellitus. The glucagon-like peptide-1 (GLP-1) receptor agonist helps the pancreas release insulin and lowers blood sugar. It also mimics the GLP-1 hormone that tells your brain you’re full.

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Innovating LNP design to improve mRNA therapeutics

European Pharmaceutical Review

A new method to improve mRNA delivery has been developed by US researchers, which could enhance the safety and efficacy of mRNA vaccines and therapies. Ionisable lipid molecules are at the centre of lipid nanoparticles (LNPs) and can switch between charged and neutral states, ultimately releasing the mRNA payload when positively charged in the target cell.