Wed.Jun 07, 2023

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Four things for CMS to keep in mind as they implement changes to Part D

PhRMA

The Inflation Reduction Act (IRA) makes significant changes to Part D’s benefit structure and coverage, which will require careful policy development and thoughtful implementation. On Monday, PhRMA submitted comments on the Calendar Year 2025 Part D Redesign changes, outlining key considerations for the Centers for Medicare and Medicaid Services (CMS) to help mitigate against potential disruptions to seniors’ access to medicines through Part D.

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The Price of New Cancer Drugs Continues To Rise

Drug Topics

The median annual cost for new oncology medicines launched in 2022 was $260,000, up from $63,534 10 years ago, an IQVIA report finds.

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STAT+: ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders

STAT

BOSTON — The drug industry has spent the past year speaking against new mechanisms that could limit how much governments or insurers pay for certain new medicines. Robert Califf, the Food and Drug Administration chief, walked on stage Wednesday and told a crowd of biotech leaders that drug costs needed fixing. “We don’t agree,” said Califf, referring to a conversation he had backstage with Ted Love , the new chair of the Biotechnology Innovation Organization.

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House Energy and Commerce Committee Looks to Reign In PBM Power

Drug Topics

The role of pharmacy benefit managers in the health care space is being scrutinized more than ever before.

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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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How the public health lessons of Covid can help Americans protect themselves from wildfire smoke

STAT

An unusually early and ferocious outbreak of forest fires across Canada has sent unprecedented amounts of smoke pollution to regions of the eastern United States unaccustomed to such hazards. Three years after the onset of the Covid-19 pandemic, the ensuing air pollution has once again put respiratory health at the forefront of many North Americans’ minds.

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Wildfire Smoke Raises Respiratory Concerns Across Northeastern United States

Drug Topics

Air quality in New York City was the worst in the world on Tuesday morning.

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Can Flexibility Fix Pharmacies? The Case for Contingent Workers

Pharmacy Times

It’s time for pharmacies to take a page out of the books of hospitals and tech companies by expanding and streamlining their use of contingent labor.

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Morning RX: June 7, 2023

Drug Topics

Cue Health gets FDA’s first de novo approval for at-home COVID-19 test, Novavax says its new vaccine will fight new variants and HHS creates new cert standards for peer support workers.

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Study Shows Association Between Sleep Apnea, Lower Brain Volume

Pharmacy Times

Having more severe sleep apneas was associated with having lower brain volume in the medial temporal lobe area of the brain, which could suggest loss of brain cells.

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Nonprofits hospitals' charity care shrank as operating incomes, cash reserves grew: study

Fierce Healthcare

Years of rising operating profits and cash reserves did not translate to greater charity care across the nation’s nonprofit hospitals, according to a study published this week in Health Affairs.

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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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Research Continues in Curing HIV Via Stem Cell Transplant

Pharmacy Times

CCR5 mutation creates a challenge for HIV to infect more cells, thereby creating resistance to the virus.

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FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi

Fierce Pharma

As Alzheimer's disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.

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The Canada wildfires are exposing the harmful effects — and health inequities — of air pollution

STAT

Wildfires blazing in and around Quebec are creating hazardous health conditions throughout North America. Over 100 million people were under alerts for unhealthy air quality as of Wednesday, and people in the Northeast and Midwest — areas that typically don’t deal with the effects of wildfires — are confronting orange-tinged, hazy skies and newly urgent questions about the harmful effects of air pollution.

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Digital Health Leaders Propose New Guidelines For Product Evaluations

Drug Topics

Existing evidence-evaluation frameworks are not sufficiently targeted toward the specific factors relevant to digital health products, they argue.

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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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Novo Nordisk's obesity drug Wegovy to be provided to more patients under UK pilot program

Fierce Pharma

The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. | The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. On Wednesday, the government unveiled a two-year pilot program that will allow Novo Nordisk’s Wegovy to be given to more overweight participants, even though the treatment has yet to be launched there.

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SCAN, CareOregon fund $110M in medical debt relief

Fierce Healthcare

SCAN Group and CareOregon have issued grants to RIP Medical Debt that will wipe out millions in patients' medical debt. | SCAN Group and CareOregon have issued grants to RIP Medical Debt that will wipe out millions in patients' medical debt.

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Investigational Individualized Neoantigen Therapy, Pembrolizumab Improve Distant Metastasis-Free Survival in Melanoma

Pharmacy Times

The combination also reduced the risk of developing distant metastasis or death by 65% in patients with high-risk stage 3/4 melanoma.

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National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them

Fierce Pharma

As pharma supply chain problems drag on, a shortage of key cancer drugs has afflicted a large number of treatment centers and many patients. | The National Comprehensive Cancer Network's recent survey shows that nearly all of the treatment centers it polled are facing a carboplatin shortage. Meanwhile, 70% of them reported a cisplatin shortage.

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One-Third of Adults With Type 2 Diabetes May Have Undetected, Symptomless Cardiovascular Disease

Pharmacy Times

Levels of troponin were higher in people who had type 2 diabetes for a longer period than people with healthy blood levels.

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Cityblock restructures operations, cuts 12% of workforce as it plots plans for growth, profitability

Fierce Healthcare

Six-year-old Cityblock Health, a startup that has raised nearly $900 million to date, has restructured its business as it focuses on ramping up payer partnerships and accelerating its path to profi | Six-year-old Cityblock Health, a startup that has raised nearly $900 million to date, has restructured its business as it focuses on ramping up payer partnerships and accelerating its path to profitability.

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STAT+: Google strikes deal with Mayo Clinic to comb patient records using generative AI

STAT

Google will embed its generative AI technology into computer systems at Mayo Clinic and other health systems to make it easier to search vast repositories of patient data and automate administrative tasks, the organizations said Wednesday. The technology is designed to function like a super-charged Google search for health records, allowing hospitals to find and link information about patients to improve care and research.

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6 benefits of apple cider vinegar for men

The Checkup by Singlecare

People have consumed vinegar for thousands of years. This potent, fermented liquid takes center stage in sauces, salad dressings, and marinades. Apple cider vinegar (ACV) is a type of vinegar that has gotten a lot of buzz over the last few years. Many wellness writers and influencers claim numerous apple cider vinegar benefits for men (and women). They say it’s a cure for everything from weight loss to erectile dysfunction.

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Reanimated hearts donated after death work just as well for transplants, study finds

STAT

A new method of heart transplantation that uses machines to reanimate donor hearts from people who have died is just as good as traditional heart transplantation, a new study finds. If adopted broadly in the U.S., the procedure that could expand the donor pool by 30%. The adjusted six-month survival rate of patients undergoing the new method was 94%, compared with 91% among patients who underwent the traditional method, according to the study published in the New England Journal of Medicine Wedn

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Eli Lilly achieving significant gains in obesity results

Pharmaceutical Technology

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. The recent rallying of Lilly’s market value has come as the result of two major announcements: its blockbuster type 2 diabetes (T2D) drug Mounjaro (tirzepatide) successfully completed its second final-stage trial for obesity, and its experimental treatment for Alzheimer’s disease completed its Ph

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Opinion: How the conversation about moral injury in health care is changing

STAT

In the new book “If I Betray These Words,” I tell the story, with Simon Talbot, of Rita Gallardo (a pseudonym): Deployed in the desert Middle East, confined to a military base ringed by Hesco barriers and razor wire, Dr. Rita Gallardo’s only escape from the horrors of the combat-shattered bodies of young service members was dreaming of the life she might build later.

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ZyVersa Therapeutics inches closer to European patent approval for VAR 200

Pharmaceutical Technology

ZyVersa Therapeutics has received a notice of intention to grant from the European Patent Office for its patent application for the cholesterol efflux mediator VAR 200 (2-hydroxypropyl-beta-cyclodextrin). The application was filed for the treatment of diabetic nephropathy/diabetic kidney disease. The Phase IIa-ready VAR 200 is being developed to reduce renal cholesterol and the lipid accumulation that damages the filtration system of kidneys in glomerular diseases patients.

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STAT+: Buoyed by cancer advances, new ASCO president also stresses honest prognosis

STAT

CHICAGO — As a busy weekend at the American Society of Clinical Oncology annual meeting wound down, Lynn Schuchter accepted a gavel from Eric P. Winer, cueing the start of her one-year term as the society’s president. Come Monday, the first official day of her presidency, Schuchter was looking ahead to her year as president. She was also still energized from the plenary session the day before — which Schuchter said was one of the best she’d ever seen.

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Fosun Pharma and IFC to build new drug manufacturing plant in Africa

Pharmaceutical Technology

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries. The funding will support the new production plant and distribution hub, which is aimed at enhancing access to high-quality medicines in Africa.

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GSK’s RSV vaccine wins European approval

STAT

LONDON — The European Commission approved GSK’s RSV vaccine, the company said Wednesday, bringing to the market the first such tool that can protect older adults from the common respiratory bug.   The vaccine, Arexvy, was authorized for adults 60 and older. Arexvy won U.S. regulatory licensure last month , as did another RSV immunization , Pfizer’s Abrysvo.

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Member Spotlight: Thomas Carganico

ISPE

Member Spotlight: Thomas Carganico Trudy Patterson Wed, 06/07/2023 - 10:31 iSpeak Blog iSpeak Member Spotlight: Thomas Carganico Edyna Miguez 7 June 2023 Since 2013, Thomas Carganico has worked extensively within the pharmaceutical services industries across the US, UK, and Europe. He provides a strong level of experience related to Digital Branding, Marketing & Strategic Communication.

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Johnson & Johnson, Legend file for expanded use of Carvykti after key trial win

Fierce Pharma

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti. | Legend Biotech and Johnson & Johnson have filed with the FDA for expanded use of Carvykti. After gaining approval 16 months ago for the CAR-T to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment.

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Opinion: Listen: Why forced treatment can’t fix substance use disorder

STAT

When a loved one is living with serious substance use disorder and refuses to get help, sometimes it seems like the only solution is to force them into it. In many states, people can be “arrescued” — that is, forced under penalty of law into a treatment program that is nearly identical to being incarcerated, down to orange jumpsuits.

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ASCO 2023 – Arun Krishna

pharmaphorum

With a 51% reduction in deaths, AstraZeneca’s ADAURA trial was one of the breakout stories of this year’s ASCO. In Chicago, Editor in Chief Jonah Comstock was able to sit down with AstraZeneca Head of Lung Cancer Commercial Arun Krishna to dive in a little bit on this practice-changing study.

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Opinion: Want to help with medical breakthroughs? Donate some extra cells to a biobank

STAT

Right now, it’s possible that cells from my body are growing in a lab somewhere and are being used to test new cancer drugs. After I was  diagnosed with neuroendocrine tumors , a rare type of cancer, I went through surgery to remove the tumors and chose to donate them to a biobank. I gave consent for the cells from my tumors to be used to create cell lines and organoids (three-dimensional tissue cultures) as models to study neuroendocrine tumors, since it is a poorly understood, unde

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