Sat.Nov 02, 2024 - Fri.Nov 08, 2024

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FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics

Drug Topics

The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.

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Study Finds Behaviors of Breast Cancer Cells Help Predict Risk of Bone Metastasis

Pharmacy Times

Using in vitro models, study investigators predict the risk of bone metastasis in breast cancer based on correlations with their in vivo behaviors and potential.

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Bird flu infections in farmworkers are going undetected, study shows

STAT

For months, as human cases of H5N1 bird flu associated with an outbreak of the virus in U.S. dairy cattle have mounted, one question has loomed larger than others: how many human infections are getting missed? Farmworkers face some of the most intense exposure to the bird flu virus, but resistance from farmers and a lack of health insurance and paid sick leave in the industry have limited the amount of testing of workers and hampered public health officials’ ability to track where the vir

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Daiichi Sankyo links up with Korea's Alteogen on subcutaneous Enhertu in $300M licensing deal

Fierce Pharma

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

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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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Two Independent Pharmacies Latest to Sue Major PBMs

Drug Topics

A collection of independent pharmacies was the next in line to file suits against major pharmacy benefit managers for alleged drug price fixing.

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Moderna Bivalent COVID-19 Vaccine More Effective at Preventing Hospitalization in High-Risk Patients Compared With Pfizer-BioNTech Vaccine

Pharmacy Times

Though both vaccines remain effective at preventing severe illness, Moderna’s mRNA-1273.222 vaccine was found to be significantly more effective among adults with underlying medical conditions.

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Novavax coughs up $123.8M to settle COVID vaccine supply dispute with UK

Fierce Pharma

Novavax has inked another settlement for a past COVID-19 vaccine supply deal. | Novavax has inked another settlement for a past COVID-19 vaccine supply deal. The Maryland biotech has agreed to pay $123.8 million to end a COVID vaccine supply pact with the U.K.

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Q&A: The Importance of Vaccine Literacy, Uptake During Flu Season

Drug Topics

Ruth Carrico PhD, DNP, APRN, discussed the importance of annual vaccination and overall health awareness and literacy during the winter flu season.

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Dupilumab Shows Significant Reductions in Itch and Hive Activity in Patients With CSU

Pharmacy Times

About 41% and 30% of patients with chronic spontaneous urticaria (CSU), respectively, achieved well-controlled disease status and complete response when treated with dupilumab.

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STAT+: Patient dies in Beam Therapeutics trial of CRISPR sickle cell treatment

STAT

A patient with sickle cell disease died while participating in a clinical trial of a CRISPR-based treatment from Beam Therapeutics, threatening to overshadow early signals of effective gene editing.  Beam said the patient succumbed to respiratory failure, deemed to be “likely caused” by a regimen of chemotherapy required to prepare the patient for BEAM-101, a treatment that uses the company’s new, more precise form of CRISPR gene editing called base editing.

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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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Eisai dials back forecasts for Alzheimer's drug Leqembi

pharmaphorum

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

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Tips For Increasing Your Independent Pharmacy’s Online Visibility | NCPA 2024

Drug Topics

Erin Rexroth, director of marketing at NCPA, discusses how smaller pharmacies can compete with large chains when it comes to digital marketing.

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GLP-1s Are At the Forefront, but Other Obesity Treatments Exist

Pharmacy Times

In addition to GLP-1s, dual GLP-1 and GIP agonists, intestinal lipase inhibitors, sympathomimetics, and other agents can help patients lose weight.

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STAT+: Private Medicare plans collect billions for care veterans are actually getting from VA 

STAT

One ad shows two older men talking jovially on a front porch, “Vietnam veteran” visible on one of their hats. Another shows an older man in military regalia, arms crossed, smiling proudly at the camera.  Under names like “Patriot Plan,” “Courage MA,” and “Honor” plan, all of the major private Medicare insurers are courting veterans directly, selling plans that their ads say complement their Veterans Affairs coverage with benefits like

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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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Handshakes and happy hours: Can HLTH affect infectious disease spread in Vegas? Verily aims to find out

Fierce Healthcare

How does a multiday mass gathering affect the local concentration of diseases like COVID-19? | Verily is working with the Las Vegas water treatment agency, water authority and health department to monitor the local wastewater for eight different pathogens. The pilot project was timed around the HLTH conference, with daily testing happening from one week before to one week after.

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Q&A: Understanding the Cause of Declining Vaccination Rates Amidst Flu Season

Drug Topics

Ruth Carrico, PhD, DNP, APRN, discussed declining influenza and COVID-19 vaccination rates and how it has created a looming threat for public health officials.

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Opioid Stewardship Pharmacist: Innovative Approaches to Pain Management

Pharmacy Times

Jeff Boyer, PharmD, BCPS, discusses his role in opioid stewardship at the Southern Arizona VA Healthcare System, highlighting his work in pain management coordination, interdisciplinary collaboration, patient and provider education, and data-driven strategies to support safe opioid use and address the opioid crisis.

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STAT+: These 7 watchdogs scour scientific papers for problems — and often find them

STAT

Researchers like to say that science is self-correcting, that knowledge is slowly but surely refined by new findings that build on or debunk old ones. But this process is far from perfect and is hampered by sloppy experiments or, in some cases, faked results. A small, tight-knit community of scientific sleuths has been unearthing growing evidence that many studies, including landmark papers published in top journals, contain manipulated images and falsified findings.

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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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Doctors, facing another pay cut in 2025, call for permanent Medicare payment reform

Fierce Healthcare

The Centers for Medicare and Medicaid Services (CMS) is moving forward with a 2.9% cut to physician payments in 2025 despite protest from major industry groups. | The Centers for Medicare and Medicaid Services (CMS) is moving forward with a 2.9% cut to physician payments in 2025 despite protest from major industry groups.

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Intra-Cellular's unstoppable Caplyta nails another trial, this time for relapse prevention in schizophrenia

Fierce Pharma

Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. | Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial.

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Women Within Health Care Face Financial Disparities and Are More Likely to Experience Burnout

Pharmacy Times

The authors believe that improvements can be made to overlook the motherhood penalty and its associated pay gaps as well as changes to address workforce burnout.

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What really happens to drug prices when patents expire

STAT

This is Part 5 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing. When patents for name brand medicines expire, the price of that medicine drops significantly as generic versions enter the market. Lower prices are good news for patients seeking more affordable medications, but the change can sometimes take a while.

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CMS puts forward meager offering for digital health in final Medicare physician fee schedule rule

Fierce Healthcare

Days before the 2024 presidential election, the Centers for Medicare & Medicaid Services (CMS) released an unpublished version of the final calendar year 2025 physician fee schedule final rule | Digital therapeutics, telehealth, rural heath clinics and opioid treatment programs all got updates in the final 2025 Medicare physician fee schedule rule, but CMS was limited by its statutory authority to make many substantial changes to digital health policy.

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Trusting COVID-19 Vaccine Science Crucial in Vaccine Acceptance Among US Adults

Drug Topics

A recent study found that losing a family member or a friend to COVID-19 within the past year led to higher levels of vaccine acceptance.

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ENVISION Trial Results Show UGN-102 Has Long-Term Durability in Patients With Bladder Cancer

Pharmacy Times

Patients with low-grade intermediate-risk non-muscle-invasive bladder cancer who achieved a complete response rate after 3 months of UGN-102 treatment had an 82.3% duration of response at 12 months.

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STAT+: Seven companies to watch in AI protein design

STAT

When this year’s Nobel Prize in chemistry went to three scientists for their work in protein structure prediction and design, the decision was indicative of a zeitgeist in biotech.   “[A] dream of scientists has been to build new proteins, to learn how to use nature’s multitool for our own purposes … opening endless possibilities for the greatest benefit to humankind,” Heiner Linke, chair of the Nobel Prize committee for chemistry, said while announci

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CMS finalizes 2.9% pay increase for outpatient facilities, ASCs, with new maternal health mandates

Fierce Healthcare

Under a final rule issued by the Centers for Medicare and Medicaid Services, outpatient hospital facilities and ambulatory surgical centers will get a 2.9% Medicare pay increase next year, up from | Under a final rule issued by CMS, outpatient hospital facilities and ambulatory surgical centers will get a 2.9% Medicare pay increase next year, up from the 2.6% boost in reimbursement that was floated in the draft rule.

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XRHealth buys NeuroReality in health XR marriage

pharmaphorum

Two players in medical extended reality (XR) – XRHealth and NeuroReality – have come together in a quest to build the biggest company in the sector.Boston, US-based XRHealth is leading the deal, acquiring NeuroReality of the Netherlands for an undisclosed sum, combining their products and expertise in the use of XR and virtual reality software for healthcare applications.

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Cognitive Remediation, Transcranial Direct Current Stimulation Slow Cognitive Decline in At-Risk Older Adults

Pharmacy Times

For up to 6 years, cognitive remediation and transcranial direct current stimulation slowed cognitive decline associated with major depressive disorder in remission and mild cognitive impairment.

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A letter from the executive editor: A seminal moment for science journalism

STAT

Dear Readers, If you’re reading this, you have likely received letters from me before, highlighting STAT’s coverage of health and medicine and appealing to you to consider becoming a subscriber. I’m here to do so again. This time, though, feels different: We are at a unique moment in our country’s history, when an understanding of the issues that STAT covers is more relevant than ever before — to both our personal lives and our professional lives.

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Hospital groups blast senators' site-neutral Medicare payment reform plan

Fierce Healthcare

Senators Bill Cassidy, M.D., R-Louisiana, and Maggie Hassan, D-New Hampshire, published a policy paper advocating to impose site-neutral Medicare payments on hospitals. | The lawmakers argue that site-neutral Medicare payment reform would lead to lower healthcare costs for patients and save taxpayer dollars. However, hospital groups were quick to slam the proposal.

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Syndax inks $350M deal with Royalty Pharma for funding to launch 2 new drugs

Fierce Pharma

With its first FDA approval coming in August and a sec | With its first FDA approval coming in August and a second expected next month, these are exhilarating days for 19-year-old Syndax Pharmaceuticals as it transforms into a commercial enterprise. To help foot the bill to launch its approved graft-versus-host disease drug Niktimvo and the expected launch of its leukemia treatment revumenib, Syndax has struck a $350 million deal with Royalty Pharma.

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Meta-Analysis Finds ICS-Formoteral and ICS-SABA Reduces Asthma Exacerbations, Improved Asthma Control

Pharmacy Times

Compared with a short-acting β agonist (SABA) alone, inhaled corticosteroids (ICS) with formoteral and ICS with a SABA were associated with better asthma control.

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