Tue.Feb 28, 2023

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Celebrating 40 years of the Orphan Drug Act on Rare Disease Day

PhRMA

For over a decade, Rare Disease Day has been celebrated on February 28 to raise awareness and generate change for the more than 30 million patients in the U.S. living with a rare disease. This year’s Rare Disease Day is particularly special because this year also marks the 40 th anniversary of the Orphan Drug Act (ODA), allowing us to celebrate all the progress that’s come to patients because of it.

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STAT Madness 2023

STAT

Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Click on each matchup for a short summary of each school’s pioneering research. Then pick your favorites. Help us crown a champ!

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PhRMA's Change Agents bring awareness and value of HBCUs and their impact to STEM

PhRMA

Historically Black Colleges and Universities (“HBCUs”), federally designated as any college or university established prior to 1964 with the principal mission of educating Black Americans, play a pivotal role in the education of people of color and in our society. In 1837, Cheyney University of Pennsylvania made history by becoming the first Historically Black College and University (HBCU) in the United States.

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FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

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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+: How Mindstrong’s rush to roll out a ‘smoke alarm’ for mental illness led to its downfall

STAT

SAN FRANCISCO — The mental health startup Mindstrong had the makings of a trailblazer in the field: top-tier leaders from companies like Google and Uber with expertise in neuroscience, medicine, and computer science. About $160 million from the same heavyweight Silicon Valley investors who bankrolled industry-shifting companies like Warby Parker and Airbnb.

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Hospitals' margins ticked downward in January but are still better off than much of 2022

Fierce Healthcare

Hospitals' margins ticked downward in January but are still better off than much of 2022 dmuoio Tue, 02/28/2023 - 15:07

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Amazon reportedly investing in ultra-fast delivery

Drug Store News

According to a report, a critical part of the company’s delivery strategy is a network of warehouses, dubbed same-day sites, which are a fraction of the size of its large fulfillment warehouses.

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Opinion: An intimate look at dementia — and the emotional toll it takes on family and caregivers

STAT

Dementia thoroughly altered my dad — and our family — and taught me just how hard it can be to care for someone with dementia. When I don’t understand something, my impulse as a photojournalist is to do a story about it. That instinct, by way of a Facebook group for caregivers of people with dementia, connected me with Leandra and George Manos, whose lives I have been chronicling since the spring of 2021.

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Lagevrio refused marketing authorisation by EMA for treatment of COVID

Hospital Pharmacy Europe

The EMA has decided not to issue a marketing authorisation for lagevrio (molnupiravir) for the treatment of adults with COVID-19 Lagevrio was refused a marketing authorisation for the treatment of adult patients with COVID-19 by the European Medicines Agency on the 23rd February 2023 although the manufacturer, Merck Sharp & Dohme B.V., may ask the EMA to re-examine its opinion within 15 days.

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STAT+: FDA approves Reata’s treatment for rare neurological disease

STAT

The Food and Drug Administration on Tuesday approved the first drug to treat Friedreich’s ataxia, a rare, neurological disease. The new drug, called Skyclarys, is made by Reata Pharmaceuticals.

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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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Decongestant medicines being reviewed by regulators after rare side effects

Hospital Pharmacy Europe

Decongestant drugs such as pseudoephedrine are now under review by health regulators following concerns over rare but serious side effects The Medicines and Healthcare Products Regulatory Agency has started a review after regulators in France alerted the European Medicines Agency (EMA) about a small number of cases. EMA officials first announced they were looking into the issue on 10 February 2023 following concerns about posterior reversible encephalopathy syndrome (PRES) and reversible cerebra

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Opinion: Redefining sustainability in health care: putting patients before profits

STAT

Sustainability appears to be a priority for most companies today, with teams of staff at major corporations dedicated to it and to providing strong messaging on its importance. But in terms of the real, practical implications for consumers, these efforts frequently fall short. In the pharmaceutical industry, sustainability is often a poorly defined buzzword, and the goal seems to be maintaining profit-making over the short term rather than sustaining health for populations in the long term.

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Pharmaceutical Care Management Association Launches Ad Campaign Defending Role of PBMs

Drug Topics

The advertisements are intended to provide education around the services that pharmacy benefit managers provide

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STAT+: Ascension, Tufts fall short of financial targets in borrowing agreements

STAT

Prominent health systems like Ascension and Tufts Medicine are falling short of financial targets set out in their borrowing agreements as they muddle through staff shortages and other challenges. Credit analysts have warned this would happen since mid-2022, but some not-for-profit hospitals are just now calculating breaches along with their 2022 financial losses.

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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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Experts push to remove barriers for physician-owned hospitals

Fierce Healthcare

Experts push to remove barriers for physician-owned hospitals fdiamond Tue, 02/28/2023 - 14:42

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An investigation into Mindstrong’s unraveling, Cerebral layoffs, and DEA looks to restrict telehealth

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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Walmart, CareSource partner to address racial health inequities

Drug Store News

Together, the companies will cultivate innovative and evidence-based solutions to improve health outcomes in under-resourced and underserved communities.

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STAT+: New head of FDA’s neuroscience office takes over at crucial time

STAT

As the Food and Drug Administration’s chief of neurology drugs, Billy Dunn was known as a hard-nosed regulator who later shepherded controversial medicines to approval under the guise of FDA “flexibility.” Now, Dunn has announced he’s retiring from the FDA , leaving the office to a regulator who is largely an unknown entity but whose decisions will carry huge weight.

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Digital health startup aims to gamify medication adherence to tackle heart disease

Fierce Healthcare

Digital health startup aims to gamify medication adherence to tackle heart disease aburky Tue, 02/28/2023 - 12:44

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STAT+: Pharmalittle: India sends two pharma execs to prison; FDA’s neurology boss departs

STAT

Good morning, all. Damian Garde here filling in for Ed Silverman on the final day of a month that, while numerically quite short, has somehow felt metaphysically interminable. Here as always is a smattering of items to help you set off on another workday of meetings, deadlines, and debating the etiquette of leaving your camera off. May it be painless, and, as always, if you hear anything interesting, do let us know.

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Cell therapy first for chronic heart failure

European Pharmaceutical Review

The largest cell therapy trial to date for chronic heart failure due to low ejection fraction (EF), has shown that mesenchymal precursor cells (MPCs) have potential for the first time to address inflammation. “This study examined the effects of [MPCs] a specific type of stem cell obtained from the bone marrow of healthy adult donors,” the study’s lead author, Dr Emerson C Perin, PhD, FACC, Medical Director at The Texas Heart Institute shared with EPR.

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Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer

Fierce Pharma

Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer aliu Tue, 02/28/2023 - 09:40

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Overcoming barriers to capturing data in a laboratory

European Pharmaceutical Review

What are the key data integration challenges faced in labs? At the risk of citing a circular issue, I would say two key challenges are both lack of data standards and a saturation of data standards. Other challenges include proprietary data formats, lack of up-to‑date equipment and inconsistent datasets. An important aspect of data integration is having different datasets in the same format (or at least a format that can be converted to match the other).

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'Podnosis': The financial trends revealed in Q4 earnings, and refocusing on patient safety in a post-COVID era

Fierce Healthcare

'Podnosis': The financial trends revealed in Q4 earnings, and refocusing on patient safety in a post-COVID era tcarey Tue, 02/28/2023 - 14:54

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Target’s key category growth in Q4 boosts revenue

Drug Store News

Fourth-quarter sales at Target were up slightly with strength in key categories such as food and beverage, beauty and household essentials.

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Aledade notches another acquisition, adds 450 practices to growing network as the primary care market heats up

Fierce Healthcare

Aledade notches another acquisition, adds 450 practices to growing network as the primary care market heats up hlandi Tue, 02/28/2023 - 11:14

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NITROSAMINES: Where now?

European Pharmaceutical Review

IN THE INITIAL PHASE of the N -nitrosamines crisis, the issue was the formation of small alkyl chain N -nitrosamines, eg, N-nitrosodimethylamine (NDMA) and N- nitrosodiethylamine (NDEA) (see Figure 1 ) in active pharmaceutical ingredients (API). 1,2 Although the presence of N -nitrosamines came as a huge surprise to industry and regulators alike, both sides rapidly responded and strategies were introduced to address the problem. 3 Figure 1 : Structures of NDMA (ChemSpider Reference 5894) and NDE

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Walgreens joins forces with Colorectal Cancer Alliance for National Colorectal Cancer Awareness month

Drug Store News

People who use the Walgreens Find Care app will find a direct link to the Alliance screening quiz to learn their risk factors for colorectal cancer.

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Insurers seeing highest margins in Medicare Advantage: KFF study

Fierce Healthcare

Insurers seeing highest margins in Medicare Advantage: KFF study pminemyer Tue, 02/28/2023 - 16:03

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National Grocers Association, RangeMe to streamline product discovery for independent grocers

Drug Store News

​​​​​​​RangeMe will feature a special collection of brands on its platform tailored to the needs of independent grocers.

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Community Health Systems sells two North Carolina hospitals to Novant Health for $320M

Fierce Healthcare

Community Health Systems sells two North Carolina hospitals to Novant Health for $320M dmuoio Tue, 02/28/2023 - 16:51

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The future of diagnosing and monitoring NAFLD/NASH could be noninvasive

Pharmaceutical Technology

The prevalence of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) continues to increase, compounded by risk factors such as advanced age, obesity, ethnicity, and type 2 diabetes mellitus (T2DM). As NAFLD progresses to NASH, the same factors also contribute to liver fibrogenesis (abnormal accumulation of fibrous tissue).

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Insurance Companies’ QZ Anesthesia Reimbursement Policies Shifts Costs to Hospitals

Fierce Healthcare

Insurance Companies’ QZ Anesthesia Reimbursement Policies Shifts Costs to Hospitals jpiatt Tue, 02/28/2023 - 12:15

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Multimillion-dollar therapies are changing how payers foot the bill

PharmaVoice

With more gene therapies headed to market, novel payment methods are emerging from regulators and academia.

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