Mon.Nov 04, 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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Turning Loss into Purpose: My Journey to a Pharmacy Career to Make a Difference

Pharmacy Is Right For Me

Meet Lila, a passionate fourth-year Pharm.D. student at Auburn University Harrison College of Pharmacy. During her APPE rotation with the American Association of Colleges of Pharmacy , Lila opened up about her inspiring journey to find the perfect pharmacy school and how, with the guidance of mentors, she discovered her true “Pharmily.” How did you choose your pharmacy school/college or graduate program?

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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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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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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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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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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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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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BioNTech reports surprising COVID vaccine sales in Q3 but tempers expectations for annual sales

Fierce Pharma

BioNTech reported surprisingly strong sales of its COVID-1 | BioNTech reported surprisingly strong sales of its COVID-19 vaccine in the third quarter. Despite the performance, the company expects to be at the lower end of its revenue guidance window for the year of between €2.5 billion to €3.1 billion.

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Opinion: How to bring more Black Americans into clinical research: Address the root causes of medical skepticism

STAT

The word “Tuskegee” has long embodied the painful symbol of medical racism, epitomizing how ethnically uninformed research practices have harmed Black Americans. It is impossible to erase this painful history. But we — one of us working for Tuskegee University, the other for Southern Research — are working on an innovative project to create a future in which Black Americans participate more fully in clinical research and share in its benefits.

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Incyte wins injunction to block launch of Sun Pharma's JAK inhibitor Leqselvi

Fierce Pharma

Despite winning an alopecia areata approval for its drug Leqselvi in July, Sun Pharma will have to wait a while longer to launch its JAK inhibitor competitor to Eli Lilly and Incyte’s Olumiant and | Sun Pharma, which had been plotting a mid-October launch for its JAK inhibitor Leqselvi, has been slapped with in an injunction blocking the rollout of the alopecia areata drug.

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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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STAT+: Medicare finalized coverage for some mental health apps. Now what?

STAT

Medicare regulators on Friday finalized rules to pay for some mental health apps, a breakthrough for digital therapeutics companies that have struggled for a foothold in the health care system. The new rule creates codes that allow clinicians to bill Medicare for providing the apps and related services to their patients. Beginning January 1, 2025, the codes will enable payment for mental health apps authorized by the Food and Drug Administration under a specific regulation that includes just a h

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NICE backs first ophthalmic bevacizumab for NHS use

pharmaphorum

Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD

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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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STAT+: Pharmalittle: We’re reading about a weight loss pill, the FDA warning a compounder, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so predictable routine of online meetings, phone calls, and deadlines has returned. But you knew this would happen, yes? The world, such as it is, continues to spin. So to cope, we are brewing a cup of stimulation in the Pharmalot cafeteria.

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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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Accord will build £50m manufacturing plant in UK

pharmaphorum

Accord Healthcare unveils £50m investment, backed by the UK government, that will see a new manufacturing facility built in Newcastle

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Report: 82.3% of Reported Vaccine Errors Reached the Patient

Pharmacy Times

The most commonly reported errors included administering the wrong vaccine or administering an expired vaccine.

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NHS pilots iPhone app to rule out throat cancer

pharmaphorum

NHS England starts pilot trial of an iPhone app and device that could be used by nurses to speed up reviews of suspected throat cancer cases.

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Thermo Fisher integrates Labguru ELN for streamlined lab management

Outsourcing Pharma

Thermo Fisher Scientific has joined forces with Labguru to integrate Labguruâs Electronic Lab Notebook (ELN) into Thermo Fisherâs Laboratory Information Management System (LIMS) and lab operations software.

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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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Incyte blocks US launch of Sun Pharma's alopecia drug

pharmaphorum

US district court grants an injunction sought by Incyte on the launch of Sun Pharma's recently approved Leqselvi for alopecia areata

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STAT+: Probe of AstraZeneca executive in China raises questions about company’s tactics

STAT

The U.K. pharmaceutical company AstraZeneca has become the largest multinational drugmaker in China, drawing 13% of its $5.8 billion in revenue last year from there, against a backdrop of an acute economic slowdown in the country and a major anti-corruption campaign aimed at the health care industry. Now, the question is whether AstraZeneca became overly aggressive in its ambitions.

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Novo puts $285m into monthly GLP-1 based on Ascendis tech

pharmaphorum

Novo Nordisk puts $285m into a once-monthly GLP-1 agonist for obesity using technology developed by fellow Danish pharma Ascendis

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Opinion: My son’s rare disease was renamed ASMD. Why are people still calling it Niemann-Pick?

STAT

Recently, the smoldering embers of conflict in my family’s rare disease community have burst into flames over the use of an eponym: Niemann-Pick. An eponym is a name derived from a person who first discovered a disease or who was otherwise closely associated with its identity. Such was the case for a neurodegenerative condition observed in a child and documented by Alfred Niemann in 1914.

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In defense of radioligand therapies, Novartis fired off patent lawsuits against Lilly and other rivals

Fierce Pharma

As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against its competitors. | As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against competitors.

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Northwestern and Case Western Reserve universities develop Huntington’s therapy

Pharmaceutical Technology

Researchers from Northwestern and Case Western Reserve universities have developed a polymer therapeutic to treat Huntington's disease.

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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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FDA grants fast track status to FELIQS’s FLQ-101 to prevent ROP

Pharmaceutical Technology

The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP).

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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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The biotech news roundup to start your week

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Morning! Today, we see even further potential for GLP-1 drugs, this time in MASH. We look at China’s probe into AstraZeneca, and have a cool video on patent thickets.

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Optimizing Health System Pharmacies: Leveraging Data, Performance Indicators, and Automation

Pharmacy Times

Health system pharmacies can enhance operational and financial performance by leveraging key performance indicators, data-driven tools, and automation, ultimately supporting the broader health system’s adaptability and growth within an evolving health care landscape.

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Nektar pads wallet with $90M manufacturing plant sale to Ampersand

Fierce Pharma

After a protracted rough patch—which has included layoffs, partnership terminations and lawsuits—San Francisco’s Nektar Therapeutics is extending its cash runway with the sale of one of its two mai | Nektar is selling its Huntsville, Alabama, manufacturing plant and reagent supply business to private equity firm Ampersand for a total value of $90 million.

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Lebrikizumab Demonstrates Improvements in Skin Clearance, Itch Relief in Patients With Atopic Dermatitis

Pharmacy Times

At weeks 16 and 24, approximately 57% and 60% of patients with moderate to severe atopic dermatitis, respectively, achieved at least 75% improvement in Eczema Area and Severity Index score.

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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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Results of ELEVATIM Show Improvement in Diabetic Macular Edema With Vabysmo for Racial, Ethnic Minority Patients

Pharmacy Times

The study investigated faricimab-svoa (Vabysmo) as treatment of diabetic macular edema for patients in racial and ethnic groups that are often underrepresented in trials.

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