Thu.Mar 07, 2024

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Independent Pharmacies Continue to Face Financial Hardships as the Clock Ticks on PBM Reform

Drug Topics

As pharmacy benefit managers gain leverage to continue driving up drug prices, local pharmacies struggle to keep up and Congress has been called to act—but it might be too late

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Girls are starting puberty earlier than ever. For some, that comes with major mental health risks

STAT

Zaria was just 9 years old when a nurse practitioner delivered news that rocked her world: The young girl was already showing signs of puberty development, and she was on track to get her period within the next year. Surprised by this timeline, Zaria’s mother, Chanell, worked with a pediatrician to plan healthier meals, hoping that managing her daughter’s weight gain could give her a couple more precious years with her childhood unchanged.

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Trending Sources

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FDA Grants Breakthrough Therapy Designation to LSD-Based Treatment for Generalized Anxiety Disorder

Drug Topics

Mind Medicine’s lysergide d-tartrate (MM120) demonstrated statistically significant and clinically meaningful improvements in anxiety symptoms in a phase 2b study.

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RSV monoclonal Beyfortus was 90% effective at preventing hospitalizations in children this winter: CDC

STAT

A new monoclonal antibody product to protect against respiratory syncytial virus was 90% effective at preventing little children from being hospitalized with RSV, according to new data from the first season it was in use. The data , published Thursday in Morbidity and Mortality Weekly Report, a Centers for Disease Control and Prevention publication, looked at how well Beyfortus worked in the children whose parents managed to secure a scarce dose of the drug.

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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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Boehringer Ingelheim to Cap Out of Pocket Inhaler Costs at $35 Per Month

Drug Topics

The out-of-pocket price cap applies to all inhalers in the company’s portfolio and will launch on June 1, 2024.

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STAT+: Nursing home owners can hide nearly two-thirds of their profits, new study shows

STAT

A new study shows that some nursing homes are shunting the majority of their profits off of their own books and into less-visible corners of their owners’ pockets. The practice makes the nursing homes look poorer than they really are, the study’s authors wrote, which seems to bolster the industry’s arguments to Congress that it can’t meet certain proposed quality standards or handle potential Medicare payment cuts.

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Opinion: Free tuition won’t fix medicine’s diversity problem without admissions reform

STAT

Medical students at Albert Einstein School of Medicine in New York City gathered last week to hear a life-changing announcement: Ruth Gottesman revealed she would be donating $1 billion, ensuring no student at Einstein will pay tuition ever again. Leadership at Albert Einstein School of Medicine celebrated the donation as a means to attract a more diverse student body.

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Telemedicine Usage Increased for Pediatric Asthma Following COVID-19 Pandemic

Pharmacy Times

Individuals with persistent asthma and at least 1 complex comorbidity were more likely to use telemedicine, the results of the study showed.

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STAT+: Boehringer Ingelheim to cap asthma inhaler out-of-pocket costs at $35

STAT

Facing criticism over its pricing, Boehringer Ingelheim plans to cap out-of-pocket costs at $35 a month for its entire line of inhalers that are used to combat asthma and chronic obstructive pulmonary disease. The program, which begins on June 1, is directed at Americans with commercial health insurance, but also at those who lack insurance and, therefore, must pay cash for their inhalers.

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GLP-1/GIP Dual Agonist Tirzepatide and its Effect on Current Weight Loss Therapy

Pharmacy Times

Promising data have emerged suggesting a significant weight loss benefit for patients using GLP-1 agonists and GLP-1/GIP dual agonists.

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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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Mark Cuban's drug company inks first health system partnership to sell directly to Community Health Systems

Fierce Healthcare

Mark Cuban Cost Plus Drug Company has found its first national health system buyer for hospital drugs currently in short supply. | The 71-hospital for-profit is the first national health system buyer to cut a deal with the billionaire-backed generic drug maker. The companies are kicking off their partnership in CHS' Texas and Pennsylvania hospitals.

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In his State of the Union, Biden takes clear aim at ‘Big Pharma’

STAT

WASHINGTON — Often, a president’s State of the Union address is a staid affair, with platitudes and calls for bipartisanship and unity. But President Biden blasted the pharmaceutical industry with its unflattering moniker, “Big Pharma,” not once, but three times Thursday night, only the second time ever that sobriquet has been used in such a setting, after Biden’s address last year.

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Public Health Matters Video: Seacrest Studios’ Impact on Children’s Hospitals and Healing Through Broadcasting

Pharmacy Times

Tune into this episode of “Public Health Matters” for valuable insights into the intersection of entertainment, health care, and child advocacy, highlighting the importance of creating supportive and interactive environments for pediatric patients.

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STAT+: Novo Nordisk’s obesity pill bests Wegovy in early trial

STAT

A pill being developed by Danish drugmaker Novo Nordisk may lead to greater weight loss than the obesity therapy Wegovy, the company reported Thursday, citing early data. In a Phase 1 trial, participants experienced an average of 13.1% weight loss after 12 weeks of taking the experimental oral medicine amycretin, according to data presented at an investor meeting.

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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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Boehringer Ingelheim cuts monthly out-of-pocket inhaler prices to $35 for US patients

Fierce Pharma

As one of Boehringer Ingelheim's asthma competitors catches scrutiny over pricing and access concerns, the company itself is taking steps to cut patient costs in the U.S. | Starting on June 1, patients will only have to shell out a maximum of $35 per month for Boehringer Ingelheim inhalers in the U.S.

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STAT+: Former medical device CEO who sold dummy, plastic parts convicted of fraud

STAT

A New York jury on Wednesday convicted the former CEO of Stimwave, a company that sold devices with dummy pieces of plastic, on two counts of health care fraud. The maximum jail sentence for each count is 20 years. Laura Perryman led Stimwave, which sold nerve stimulation devices to combat pain, from 2010 to 2019. Under her leadership, Stimwave distorted the design of the device to better fit insurance codes, resulting in unnecessary plastic components that allowed the company to sell its produc

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ICHRA is having a moment. VCs are taking notice and looking to invest in the emerging space

Fierce Healthcare

Individual coverage health reimbursement arrangements, otherwise known as ICHRA, are enjoying a surge in popularity. | Venture capital firms are looking toward the ICHRA market as a potential opportunity because of its growing popularity among small employers and remote companies.

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FDA Approves Nivolumab-Based Regimen for First-Line Treatment in Adult Patients With Urothelial Carcinoma

Pharmacy Times

Patients with urothelial carcinoma who were treated with the nivolumab-based regimen had better OS and PFS compared with those who received cisplatin with gemcitabine alone.

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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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After withdrawal, GSK touts another Blenrep combo win as analysts build blockbuster case for the myeloma ADC

Fierce Pharma

GSK has more trial evidence to support a potential comeback for its withdrawn antibody-drug conjugate Blenrep. | GSK has more trial evidence to support a potential comeback for its withdrawn antibody-drug conjugate Blenrep. And analysts are already assigning blockbuster sales figures to the medicine.

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Hackensack Meridian hospitals first to attain Joint Commission's new sustainability certification

Fierce Healthcare

Four Hackensack Meridian Health (HMH) hospitals are the first in the country to achieve the Joint Commission’s sustainable healthcare certification. | Four Hackensack Meridian Health hospitals are the first in the country to achieve the Joint Commission’s sustainable healthcare certification. The voluntary program for hospitals went into effect at the start of this year and provides a framework to help organizations tackle decarbonization efforts.

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How natural language processing can make a difference in pharma

pharmaphorum

On today’s podcast, host Jonah Comstock welcomes Jane Reed, director of life sciences at IQVIA NLP, the new name for recent IQVIA acquisition Linguamatics. Reed talks through some of these different technologies and use cases and describes how natural language processing has exciting potential in translating real-world conversations on social media into pharmaceutical adverse event reports.

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STAT+: A deep dive into Applied Therapeutics’ data, and questions on Cassava’s erased data

STAT

Have you heard the news? I’m launching a weekly email newsletter starting on March 28. It’s called Adam’s Biotech Scorecard and it’s exclusively for STAT subscribers. One catch: We need you to sign up, which you can do here. What should you expect to see in my newsletter each week? Unfiltered, uncompromising, and (hopefully) valuable insight and analysis from the intersection of Wall Street and biotech.

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Gilead and MSD say weekly oral therapy controls HIV

pharmaphorum

Gilead and MSD showcase once-weekly oral HIV regimen at CROI congress, as ViiV presents new data on injectable Cabenuva in patients with low adherence to daily oral therapy

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FDA Grants Accelerated Approval to Zanubrutinib for R/R Follicular Lymphoma

Drug Topics

This is the fifth oncology indication for zanubrutinib in the United States

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GSK scores again with Blenrep in multiple myeloma

pharmaphorum

GSK continues to build the case for its multiple myeloma therapy Blenrep, which was pulled from the US market last year, with another positive phase 3 trial. The BCMA-targeted antibody-drug conjugate (ADC), given in a regimen with pomalidomide plus dexamethasone (PomDex), was shown to be more effective at preventing disease progression or death than Johnson & Johnson’s $10 billion-a-year anti-CD38 antibody Darzalex (daratumumab) with PomDex in the head-to-head DREAMM-8 trial.

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Tocilizumab-aazg Is First IV, Subcutaneous Tocilizumab Biosimilar With FDA Approval

Drug Topics

The biosimilar represents a comprehensive, accessible, and high-quality treatment option for patients in the US treated with tocilizumab.

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Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development

pharmaphorum

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development Mike.

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Biden to call for drug negotiation expansions, stronger reproductive care access at SOTU

Fierce Healthcare

Healthcare policy wins and promises of further action on prescription drug prices, insurance coverage and reproductive care access are primed for the spotlight when President Joe Biden takes the ro | Speech previews from the White House celebrate and call for expansions to the Inflation Reduction Act. Reproductive care is also expected to headline, as are efforts around coverage parity and antitrust.

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BJ’s Wholesale Club releases Q4, full fiscal 2023 results

Drug Store News

BJ’s strong fourth quarter caps a year underpinned by membership, traffic and market share growth.

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Eli Lilly flags bacteria, impurity concerns in fake and compounded versions of popular GLP-1 meds

Fierce Pharma

With the swelling popularity of Eli Lilly’s diabetes med Mounjaro and its weight loss counterpart Zepbound, unauthorized copycats continue to emerge, posing a growing safety risk. | The company republished an open letter reiterating its commitment to taking legal action against scam sellers after discovering bacteria and impurities in some of the fraudulent meds.

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Kroger reports Q4, full year 2023 results

Drug Store News

Kroger reported total company sales were $37.1 billion in the fourth quarter, including $2.7 billion from the 53rd week, compared to $34.8 billion for the same period last year.

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Despite Leqembi's launch pains, Eisai projects Alzheimer's med will reach $8.8B in the long run

Fierce Pharma

Despite weathering a host of launch challenges with Leqembi, Eisai still has big hopes for its amyloid-busting antibody in early Alzheimer’s disease. | By Eisai’s 2026 fiscal year—which ends in March 2027—the company figures its Alzheimer's disease drug Leqembi can bring home 290 billion Japanese yen (nearly $2 billion) in global revenues. Come fiscal year 2032, those sales could potentially swell to a whopping 1.3 trillion yen ($8.8 billion).

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

By Mark A. Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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