Tue.Sep 17, 2024

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STAT+: Express Scripts sues FTC over a ‘biased’ report about pharmacy benefit managers

STAT

Express Scripts, one of the largest pharmacy benefit managers in the U.S., filed a lawsuit on Tuesday demanding that a recent Federal Trade Commission report accusing industry middlemen of raising drug prices be vacated. In scathing language, the company argued the report was “seventy-four pages of unsupported innuendo leveled … under a false and defamatory headline.

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Express Scripts files suit against FTC, demands retraction of report on PBM industry

Fierce Healthcare

Express Scripts has filed suit against the Federal Trade Commission, demanding that the agency retract a damning report on the pharmacy benefit management industry. | Express Scripts is suing the Federal Trade Commission, demanding that the agency retract a damning report on the pharmacy benefit management industry.

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Trending Sources

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STAT+: From Epic to FDA, all the leaders presenting at HHS’ invite-only AI in health care event

STAT

Federal health officials wrestling with when and how to use artificial intelligence will on Wednesday host an invitation-only meeting of AI leaders across industry, academia, and government. Called “AI in Action: Transforming Health and Human Services,” the three-hour event is hosted by the federal health department. Its agenda illustrates a department excitedly working through how AI fits into its mission — as well as into the United States’ broader health care syste

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Amazon inks digital health partnership with Talkspace, adds mental health provider to health conditions program

Fierce Healthcare

Amazon has added virtual behavioral health provider Talkspace to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits. | Amazon has added virtual behavioral health provider Talkspace to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.

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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+: What pharma companies and insurers think about Medicare’s plan to cover digital treatments

STAT

In July, Medicare proposed to start paying for some mental health apps, in a move applauded by the developers of those treatments after years of struggling to find adoption among clinicians and patients. But it wasn’t only the startups and their supporters that took notice — some of the largest pharma and health care companies in the country, like Pfizer and CVS Health, weighed in on the proposal during the comment period, arguing for modifications that suit their vision for how di

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Noom to offer compounded GLP-1 drug to rival pricey branded weight loss meds

Fierce Healthcare

Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers. | Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers.

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J&J talc appeal upends $260M award to Oregon woman with mesothelioma

Fierce Pharma

Three months after a jury awarded $260 million to an Oregon woman who claimed | Three months after a jury awarded $260 million to an Oregon woman who claimed that her use of Johnson’s Baby Powder caused her to develop mesothelioma, a state judge has overturned the verdict and granted the company a new trial.

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A documentary film asks: Can health systems improve patient safety by embracing new tech?

STAT

Reetam Ganguli once pitched his technology, to rescue women from pregnancy complications, in an airplane bathroom. He often works all night, when other recent college graduates are partying. And he sometimes goes weeks without seeing his girlfriend — or any friend at all. But in the midst of his sacrifices, things are looking up.

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Prevalence of Obesity in the US Remains at All-Time High

Drug Topics

The CDC recently released a report detailing 2023 statistics regarding adult obesity within the 50 US states.

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STAT+: 11 people shaping psychedelics drug development

STAT

The field of psychedelics, once relegated to the fringes of science and medicine, is in the midst of both transformation and flux. Several key figures stand out in their efforts to push forward the advancement of psychedelic medicine, in the face of ongoing controversy , regulatory hurdles , and stigma. Psychiatric medicine hasn’t seen much innovation in recent decades, even as many say that drugs like psilocybin, MDMA, and DMT can offer real hope to millions of people who suffer from men

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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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FDA clears sleep apnoea feature for new Apple Watch

pharmaphorum

Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.The Breathing Disturbances function is part of watchOS 11, which makes its debut today alongside the release of the latest Apple Watch Series 10 which was revealed at the company's new product reveal earlier this month and is due to become available on 20th September.

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FDA formalizes protocol for international cancer trials

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. I’m in New York this week with my colleague Adam Feuerstein for the Cantor Fitzgerald Healthcare Conference. Say hi if you’re there and you see us!

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F2G raises $100 million to combat innovation 'paucity in antifungals

Outsourcing Pharma

One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.

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The healthcare issues keeping employers up at night

Fierce Healthcare

Employers hold significant power in the healthcare industry. | In this week's episode of "Podnosis," we're diving into the healthcare topics employers are watching most closely.

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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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STAT+: Pharmalittle: We’re reading about an Express Scripts lawsuit against FTC, AMR deaths, and more

STAT

Top of the morning to you, and a fine one it is, despite the gray skies hovering over the Pharmalot campus. We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us.

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Advances in CAR T-Cell Therapy and Bispecifics for Relapse/Refractory Multiple Myeloma: Insights From ESMO Congress 2024

Pharmacy Times

The efficacy and safety profiles of CAR T-cell and bispecific antibody therapies have led to their investigation in earlier lines of therapy, with several new treatments in development.

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STAT+: U.S. agency threatens J&J with sanctions if it switches payments to 340B hospitals

STAT

A U.S. government agency has threatened Johnson & Johnson with sanctions if the company proceeds with plans to alter payment methods for some hospitals that participate in a federal drug discount program. In a letter sent on Tuesday, the U.S. Health Resources and Services Administration maintained that a J&J plan to issue rebates for two widely prescribed medicines instead of offering discounted prices would violate federal law.

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Navigating Nephrolithiasis: A Pharmacist's Perspective

Drug Topics

Mark Garofoli combined personal anecdotes with professional expertise to deliver a compelling presentation on kidney stone pain at this year’s PAINWeek National Conference.

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Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer

Fierce Pharma

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

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Discussing the Lack of Transparency in GPOs of 'Big 3' PBMs

Drug Topics

Greg Baker, CEO of AffirmedRx, gave a presentation at the PBMI Annual National Conference where he talked about PBM trends and their impact on employers.

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FDA Clears First 1-Year Continuous Glucose Monitoring System for Diabetes

Pharmacy Times

Eversense 365 (Senseonics) is the first long-lasting continuous glucose monitoring (CGM) system, which includes a 365-day sensor and only 1 insertion on Day 1 of every year.

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uMotif expands site and patient platform with ClinOne acquisition

Outsourcing Pharma

uMotif, a fast-growing company in the clinical research technology sector, has taken a significant step in expanding its platform with the acquisition of ClinOne, a provider of site platform solutions.

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Trial sets up filings for Boehringer IPF drug nerandolimast

pharmaphorum

Boehringer will file its idiopathic pulmonary fibrosis drug nerandolimast next year, a successor to its blockbuster Ofev, after a phase 3 win

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Assessing the Current Landscape of Supportive Care in Oncology

Drug Topics

A study found there were 216 active supportive care clinical trials and that industry sponsors rarely provided funding.

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Mitigating diagnostic errors in clinical trial participants: The role of drug safety/pharmacovigilance

pharmaphorum

Mitigating diagnostic errors in clinical trial participants: The role of drug safety/pharmacovigilance Mike.

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Biden administration unveils multi-agency patient safety programs, industry commitments

Fierce Healthcare

The Biden administration met World Patient Safety Day with a blitz of new programs, panel discussions and commitments from government agencies as well as healthcare industry organizations all focus | A patient safety forum held at the White House came with several agency announcements and discussions with health systems tackling harm reduction and workforce culture.

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Long-Term Survival Rates Improve with Dual Immunotherapy in Metastatic Melanoma

Pharmacy Times

Ten-year follow up data showed a sustained survival benefit with nivolumab-ipilimumab in advanced melanoma.

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After FDA no, MSD/Daiichi post new data with lung cancer ADC

pharmaphorum

MSD and Daiichi Sankyo's patritumab deruxtecan hit its main objective in a phase 3 lung cancer study that reinforces its potential as a new treatment option for patients after first-line treatment with EGFR inhibitors.The HERTHENA-Lung02 study in EGFR-mutated non-small cell lung cancer (NSCLC), involving patients with locally advanced or metastatic disease previously treated with EGFR drugs, revealed a significant improvement in progression-free survival (PFS) compared to a chemotherapy regimen.

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CDMO Serán snags $200M Bain-led investment to build its first commercial facility

Fierce Pharma

With a hefty investment led by Bain Capital and a new commercial facility on the horizon, growing CDMO Serán Bioscience is looking to bridge the gap between clinic and market for its cust | With a hefty investment led by Bain Capital and a new commercial facility on the horizon, growing CDMO Serán Bioscience is looking to bridge the gap between clinic and market for its customers.

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Lawmakers, policy experts spar over the Inflation Reduction Act in Senate hearing

Fierce Healthcare

Tuesday's Senate Committee on Finance hearing on the Inflation Reduction Act (IRA) featured both proponents and critics of recent health policy decisions throwing punches, many of which have been p | Lawmakers and policy experts disagreed on whether the Inflation Reduction Act's strengths outweigh its weaknesses as well as the best path forward.

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FDA awards Novartis expanded approval for breast cancer therapy

STAT

Kisqali, a key targeted therapy for breast cancer from Novartis, until now has been indicated only for patients with metastatic disease. But on Tuesday, the Food and Drug Administration approved Kisqali in combination with hormone therapy for patients with certain early-stage breast cancers, significantly expanding the number of patients who will have access to this type of drug.

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Coherus' cancer biosimilar faces supply squeeze after company's contract manufacturer overextends itself

Fierce Pharma

Nearly a year after Coherus BioSciences’ on-body injector for Udenyca was rejected over external production issues, a third-party manufacturer has caused another spot of bother for the Ca | Thanks to “over-commitments and capacity constraints” facing the U.S.-based contractor in charge of final packaging for Coherus' Udenyca, the copycat cancer med will suffer a “temporary” supply interruption, the company said last week.

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Cancer Diagnosis Rates Remain Lower Than Expected Due to COVID-19 Pandemic

Pharmacy Times

In 2021, cancer diagnosis rates remained low after major disruptions during the first year of the COVID-19 pandemic.

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How Do White Label Products Work for Pharmacies?

PioneerRx

As you well know, there are countless ways to make more money for your pharmacy. From leveraging your pharmacy technology to expanding your clinical services.