Thu.Mar 02, 2023

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Why Congress should prioritize fixing the 340B program

PhRMA

Nearly all Americans nationwide agree: Lowering out-of-pocket costs for health care should be a top priority for policymakers. Luckily, there are commonsense policies Congress could implement to meaningfully address the cost burdens Americans face. These include things like making sure patients aren’t paying more for their medicines than their health insurance company or requiring first-dollar coverage, so insurance companies cover the cost of certain lifesaving medicines from day one of the pla

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Eli Lilly Slashing Insulin Prices, Capping Monthly Out of Pocket Costs For Many

Drug Topics

The pharmaceutical giant announced a 70% price reduction for most of its commonly sold insulin.

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Insurer and PBM tactics are shifting higher costs to patients with chronic and complex conditions

PhRMA

Health plans are increasingly using deductibles and coinsurance to shift more of the cost of care to chronically ill patients taking brand medicines. As data from IQVIA show, this alarming trend is especially burdensome for patients with cancer, who pay nearly 10X more on average per year for their medicines when they face deductibles and coinsurance versus patients with only fixed copays.

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Report: Obesity could cost the world over $4 trillion a year by 2035

STAT

The costs of obesity are projected to soar globally, in step with rising prevalence, according to a new report from the World Obesity Federation, the only group focused solely on tracking global obesity trends and a partner of the World Health Organization. Over half the world’s population will be either overweight or have obesity by 2035, the report projected, while the economic impact of a high BMI could reach $4.32 trillion annually, if current trends continue and policy inertia around

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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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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is indicated to treat the ultra-rare, inherited neurodegenerative disorder in 16 years and above-aged adults and adolescents in the US. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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How policymakers could tweak HIPAA to better protect abortion records

STAT

WASHINGTON — Patient privacy law offers little protection if law enforcement requests a person’s medical records — an issue that’s fueled concern as states impose restrictions on abortion after the Supreme Court overturned Roe v. Wade. “I think it’s important to know that right now, your health records aren’t necessarily protected.

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Same patient, same drug, same insurer — coverage denied

STAT

Janice Morales-Ferrer is a planner. It’s helped her get ahead in her career and in raising three young kids. But it’s hard to plan when you’ve got a rare disease, especially one with no standard treatment regimen or predictable outcome. “I’m a data-driven person,” said the 46-year-old Boston area resident. “It’s frustrating for me to not be able to plan how long I can live for my kids.

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Helina Blogs: Living in Duality

Colors Make me Happy

A person cannot physically be in two places at once, but their mind and soul certainly can be. When I landed in America as a teenager, I had no doubt that I was a Kurdish refugee from Iraqi Kurdistan. Being young, America quickly made its way into my mind, body, and soul—and I’m glad that it did. But after that, the duality set in. There are so many aspects of the U.S. that I love, as there are so many things about Kurdistan that I not only love, but feel have created me.

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Double win for StudyKIK's oncology and cash apps helping trial patients

Outsourcing Pharma

Year on year, the SCOPE summit brings thousands of people working in the pharma field together and the last one attracted more than 2,300 leaders in clinical operations and research.

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FDA panel backs GSK RSV vaccine ahead of approval

Pharmafile

Yesterday, GSK shared that an advisory committee from the FDA voted in support of its respiratory syncytial virus (RSV) vaccine candidate for older adults. This support is ahead of an official FDA approval for the company’s vaccine. GSK has shared that a final decision is expected to be made by the FDA ahead of the 3 May.

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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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Double win for StudyKIK's oncology and cash apps helping trial patients

Outsourcing Pharma

Year on year, the SCOPE summit brings thousands of people working in the pharma field together and the last one attracted more than 2,300 leaders in clinical operations and research.

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Palmless’ nourishing oil features sustainable alternative to palm oil

Drug Store News

Save the F#$%ing Rainforest Nourishing Oil is a multipurpose product designed to tackle palm-driven deforestation's destructive environmental and social impacts, the company said.

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Merck reports rise in group net sales in fiscal 2022

Pharmaceutical Technology

Merck has reported an increase in group net sales by 12.9% to €22.23bn in fiscal 2022 against €19.68bn in 2021. The growth in sales was driven by all regions and business sectors, particularly Life Science. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022. Favourable foreign exchange effects of 6.1% resulted primarily from the development of the US dollar and the Chinese renminbi.

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Opinion: New analysis: CMS vastly overestimates hospital price transparency efforts

STAT

More than two years after a federal rule required hospitals to post their actual prices, the Centers for Medicare & Medicaid Services has finally responded to public pressure about the failure of many hospitals to be transparent about what they charge for their services. Unfortunately, CMS’s new hospital compliance report gaslights American health care consumers by claiming that most hospitals are following the rule.

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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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NCPA, NACDS commend House committee investigation on PBMs

Drug Store News

NCPA and NACDS are praising the U.S. House of Representatives’ Committee on Oversight and Accountability for launching an investigation into pharmacy benefit managers.

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FDA rejected Neuralink study pitch, Meta and ByteDance get into proteins, & Color layoffs

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Hy-Vee dietitians to offer free omega-3 index screenings in March

Drug Store News

Some 2,000 free omega-3 index screenings will be provided at select Hy-Vee stores throughout its eight-state region as a part of National Nutrition Month.

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STAT+: Presbyterian and UnityPoint propose latest cross-market hospital merger

STAT

In what may well be the latest fad in hospital consolidation, two not-for-profit health systems located across the country from one another are seeking to link up — this time, to create a system with roughly $11 billion in revenue. UnityPoint Health and Presbyterian Healthcare Services announced Thursday they’ve inked a letter of intent to explore a merger.

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Telelactation startup SimpliFed teams up with Nature's One to expand access to affordable organic baby formula

Fierce Healthcare

Telelactation startup SimpliFed teams up with Nature's One to expand access to affordable organic baby formula agliadkovskaya Thu, 03/02/2023 - 13:52

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Listen: The next CRISPR fight, cheaper insulin, & an FDA shuffle

STAT

Who invented CRISPR 2.0? What happens when a drug company actually lowers prices? And is Novavax going to survive? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Allison DeAngelis joins us to explain how the latest CRISPR breakthrough is shaping up to be a free-for-all among a multitude of companies and labs, including some of the biggest names in biotech.

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Walgreens Boots Alliance sells 15.5M shares of Option Care Health

Drug Store News

After the sale, Walgreens Boots Alliance’s ownership of Option Care Health’s common stock decreased from approximately 14% to approximately 6%.

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Humana, Aledade ink 10-year value-based care partnership

Fierce Healthcare

Humana, Aledade ink 10-year value-based care partnership pminemyer Thu, 03/02/2023 - 15:52

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Walmart to open 28 new Walmart Health Centers

Drug Store News

This expansion will increase Walmart Health’s footprint into two new states, including Missouri and Arizona.

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Primary care business Cano Health secures $150M loan as its losses swelled in 2022

Fierce Healthcare

Primary care business Cano Health secures $150M loan as its losses swelled in 2022 hlandi Thu, 03/02/2023 - 08:12

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Prioritising for a data-driven 2023

European Pharmaceutical Review

Last year was another challenging one for the pharmaceutical industry. On top of residual pandemic-related challenges and supply chain issues, the ever-adapting regulatory environment has continued to set new standards and enforce new requirements. This article explores some of the most notable developments of 2022, and areas that are likely to be a growing focus for data-driven transformation in 2023.

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STAT+: Pharmalittle: FDA panel backs a GSK vaccine for RSV; opioid wholesalers cleared of liability to Georgia families

STAT

Hello, everyone, and how are you this morning? A spot of rain is falling on the Pharmalot campus, making for a gloomy start to yet another busy day. The official mascot, for instance, is put off — instead of gallivanting about the grounds, he remains curled up in a ball alongside us. Nonetheless, our spirits remain sunny. How so? We will trot a favorite bit of wisdom from the Morning Mayor: Every new day should be unwrapped like a precious gift.

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EMA’s human medicines committee (CHMP) meeting highlights – February 2023

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, gave one negative opinion, plus four positive opinions on therapeutic indications extensions in its February 2023 meeting. Eight new medicines recommended for approval The CHMP recommended granting a marketing authorisation for Akeega (niraparib/abiraterone acetate) for metastatic castration-resistant prostate cancer with BRCA 1/BRCA 2 mutations.

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FDA Accepts Verrica's Resumbitted NDA for VP-102

Drug Topics

VP-102 hopes to treat molluscum contagiosum, pending approval from FDA

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Enhancing bioavailability formulations containing soluble acidic drugs

European Pharmaceutical Review

A Gastrointestinal Simulator (GIS) was found to be superior to the traditional United States Pharmacopoeia (USP) method in predicting in vivo performance of Biopharmaceutics Classification System (BCS) Class IIa compounds. As the bioavailability enhancement of poorly soluble drugs requires a thorough understanding of the desired formulation , the appropriate in vitro modelling of the absorption mechanism is essential.

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Novo Nordisk to create one of its largest R&D hubs outside of Denmark

Outsourcing Pharma

Novo Nordisk is to expand its research and development (R&D) presence in the greater Boston metro area.

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Register Today to Attend the Next Total Pharmacy® Solutions Summit

Drug Topics

The Total Pharmacy® Solutions Summit will take place on April 8, 2023.

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Kroger builds upon impressive Q4 earnings with full year results

Drug Store News

The retailer’s Q4 saw identical sales without fuel increase by 6.2%, while total company sales were $34.8 billion.

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FDA: Nerivio Cleared for Migraine Prevention

Drug Topics

Nerivio received clearance in January 2021 for use in acute migraine.

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Cetaphil launches AI skin analysis tool

Drug Store News

The digital, comprehensive skin analyzer will offer users personalized skin assessments and skin care recommendations.

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