Mon.Jul 29, 2024

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Drug Topics Top 10: Most Read Stories From July 2024

Drug Topics

Check out this list of our top 10 most read stories from July 2024.

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STAT+: Sarepta demanded Duchenne patient advocacy group censor video critical of the company

STAT

Sarepta Therapeutics demanded a prominent patient advocacy organization censor a video that contained pointed criticism of the company’s recently approved gene therapy for Duchenne muscular dystrophy, STAT has learned. The incident raises questions about the financial ties between Sarepta and the advocacy group, Parent Project Muscular Dystrophy, and whether the drugmaker uses its money to influence, or even muzzle, debate over its Duchenne medicines.

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FDA Approves Benzgalantamine for Treatment of Alzheimer Disease

Pharmacy Times

Benzgalantamine (Zunveyl; Alpha Cognition) is a cholinesterase inhibitor indicated for the treatment of mild-to-moderate dementia in adults.

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STAT+: In a big step for liquid biopsy, FDA approves a blood test for colorectal cancer

STAT

The Food and Drug Administration on Monday approved a blood test intended to detect colon cancer, a product many experts hope will help catch cases of the disease early enough so that they can be more easily treated. The test, called Shield and made by Guardant Health, a Palo Alto, Calif.-based biotech firm, comes with a drawback: It is not as good as a colonoscopy and other tests at detecting precancerous or early stage cancers.

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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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Long-Acting Injectable Form of Cabotegravir Safe for HIV Prevention in Pregnant Cisgender Women

Pharmacy Times

An extension of a long-acting cabotegravir study shows safety prior to and during pregnancy in cisgender women, with full results being presented at the 2024 International AIDS Conference.

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Could cow vaccines help halt the spread of bird flu in U.S. herds? Experts are divided

STAT

With the number of U.S. dairy herds infected with H5N1 bird flu rising almost daily, fears are growing that the dangerous virus cannot be driven out of this species. That belief is amplifying calls for the development of flu shots for cows. Multiple animal vaccine manufacturers are reportedly at work trying to develop such products. And the U.S. Department of Agriculture is eagerly encouraging the effort, detailing in a notice last week what kinds of evidence would be needed to win licensing app

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Bird flu snapshot: Upstart manufacturers in low- and middle-income countries to start early vaccine work

STAT

Bird flu snapshot: This is the latest installment in a series of regular updates on the H5N1 flu outbreak in dairy cows that STAT is publishing on Monday mornings. To read future updates, you can also subscribe to STAT’s Morning Rounds newsletter. A network of nascent vaccine manufacturers in low- and middle-income countries will soon start preliminary work to develop messenger RNA vaccines targeting the H5N1 bird flu virus, an effort that could speed production during a pandemic, should

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HSA administrator HealthEquity discloses data breach impacting 4.3M

Fierce Healthcare

HealthEquity, a prominent health savings account administrator, has disclosed a data breach it says impacted 4.3 million people. | The company filed a notice with Maine's attorney general and revealed that it received an alert on March 25 about a potential security incident, and then proceeded to conduct an investigation.

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Blood tests for Alzheimer’s diagnosis were 91% accurate in new study

STAT

New blood tests could help doctors diagnose  Alzheimer’s  disease faster and more accurately, researchers reported Sunday – but some appear to work far better than others. It’s tricky to tell if memory problems are caused by Alzheimer’s. That requires confirming one of the  disease’s hallmark signs  — buildup of a sticky protein called beta-amyloid — with a hard-to-get brain scan or uncomfortable spinal tap.

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Proposed Trastuzumab Biosimilar Shows Pharmacokinetic Similarity to Reference Product

Pharmacy Times

The similarities were shown for both the US formulation and the EU formulation.

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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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New cardiovascular risk model could greatly decrease use of statins and increase heart attacks, study warns

STAT

If up to half of Americans no longer qualify for a statin or a blood pressure medication based on a new calculator updated to better predict their risk, that could lead to 107,000 more heart attacks and strokes over 10 years, a new study estimates. The research paper, published Monday in JAMA , is the second in two months drawing attention to widely used medicines designed to prevent the leading cause of death in the United States.

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Alpha Cognition's delayed-release Alzheimer's drug Zunveyl passes muster with FDA

Fierce Pharma

Amid an influx of new drugs targeting one of the believed root causes of Alzheimer’s disease, a new symptomatic med has hit the scene, courtesy of Vancouver’s Alpha Cognition. | Amid an influx of new drugs targeting one of the believed root causes of Alzheimer’s disease, a new symptomatic med has hit the scene, courtesy of Vancouver’s Alpha Cognition.

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STAT+: Parasite engineered to treat brain development disorder in mice shows potential in study

STAT

The human body works hard to prevent outside substances from entering the brain — which makes it a challenge to get drugs into the brain to treat neurological diseases. A study published today in Nature Microbiology opens the door to a potential clever solution, showing how Toxoplasma gondii, a parasite that is able to cross the blood-brain barrier, can be engineered to treat a brain development disorder in mice.

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AstraZeneca trumpets new Calquence combos in CLL. Can they change clinical practice?

Fierce Pharma

With a phase 3 trial win claimed by AstraZeneca, the heated BTK inhibitor race might see its first triplet regimen in chronic lymphocytic leukemia (CLL). | With a phase 3 win claimed by AstraZeneca, the heated BTK inhibitor race might see its first triplet regimen in chronic lymphocytic leukemia.

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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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Opinion: Mark Cuban’s company won’t fix drug costs, but it can still help rectify America’s drug shortages

STAT

Americans are facing at least two prescription drug crises simultaneously. One is the outrageously high cost of drugs, which runs to more than $500 billion per year. The other relates to extreme drug shortages requiring rationing of lifesaving medications. Crises can generate opportunities. Mark Cuban, the wildly successful entrepreneur and NBA owner, has committed himself to solving these two problems.

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Prescribing Newborns Opioids, Methadone Varies Significantly Across Children’s Hospitals

Drug Topics

Researchers analyzed the prominence of opioid and methadone prescriptions for hospitalized newborns with substantial morbidities.

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STAT+: Disruptions loom for telehealth providers and patients as Congress inches closer to deadline

STAT

Around November, Kivo Health, a telehealth provider of pulmonary rehabilitation services, will need to start warning older patients that their sessions may not be covered by Medicare in the new year. Kivo was founded in 2022, and it’s covered by Medicare thanks to telehealth flexibilities passed by Congress during the Covid-19 pandemic. Those flexibilities expanded what kinds of care people on Medicare can receive over telehealth — but they are set to expire at the end of 2024.

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Front-Line Impacts of Point-of-Sale DIR Fees on Community Pharmacies: Mid-Year Update with AAP

Drug Topics

A roundtable session discussed the real-world implications of applying Direct and Indirect Remuneration (DIR) fees at the point of sale rather than through retroactive clawback.

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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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Morning Rounds: Would a bird flu vaccine for cows work?

STAT

Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. Happy Monday! Are you watching the Olympics this week? As a former distance swimmer, I’m a big fan of watching Katie Ledecky smoke everyone in the mile.

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CMS announces new ‘premium stabilization’ program

Fierce Healthcare

The Centers for Medicare & Medicaid Services is creating a voluntary demonstration program to support changes to Medicare Part D under the Inflation Reduction Act.

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With multi-state agreement worth $86M, Indivior moves to resolve more opioid litigation

Fierce Pharma

Suboxone maker Indivior has spent years dealing with allegations related to its role in the United States opioid epidemic, inking several settlements over that span and even witnessing its former C | More than a dozen states linked up on the agreement after accusing Indivior of fueling the opioid epidemic with its opioid addiction treatment Suboxone.

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Ipsen's Alagille drug backed by CHMP again, with new name

pharmaphorum

Ipsen gets CHMP backing for Alagille syndrome therapy odevixibat, with a new brand name that it hopes will unlock orphan status in the EU

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After tense standoff, AstraZeneca and Daiichi's Enhertu turned away by NICE on pricing grounds

Fierce Pharma

After a prior skirmish over tax policy in England, AstraZeneca is now butting heads with | After a prior skirmish over tax policy in England, AstraZeneca is now butting heads with officials in the country over innovative drug access.

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UK partnership aims to support NHS use of depression app

pharmaphorum

Otsuka has teamed up with one of the innovation arms of the NHS to explore how a digital therapeutic (DTx) for major depressive disorder (MDD) could be deployed within the health service.The alliance with Health Innovation Oxford & Thames Valley (Oxford HIN) is focusing on Care for MDD, an app-based DTx that has been co-developed by Otsuka and digital health specialist Click Therapeutics.

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Elevate and Thrive: Increasing Pharmacy Profits with MTM and Patient Engagements Solutions

Drug Topics

Lauren Adair, PharmD, director of network enablement at Outcomes, discussed developments in the expanding role of pharmacists amidst rising health care costs.

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GSK joins Flagship's flotilla of pharma partners

pharmaphorum

Flagship Pioneering signs another strategic-level deal with a big pharma group, with GSK agreeing an alliance potentially worth more than $7 billion

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Taking Care of Transparency in Drug Pricing, So Pharmacy Can Take Care of Patients

Drug Topics

Erin Albert, Vice President of Pharmacy Relations and Chief Privacy Officer at Mark Cuban Cost Plus Drug Company, PBC, discussed the changing landscape regarding prescription drug pricing.

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Rainwater Foundation, CurePSP, Aging Mind Foundation fund innovative tauopathy research

Outsourcing Pharma

The Rainwater Charitable Foundation (RCF), in collaboration with CurePSP and the Aging Mind Foundation (AMF), has announced the allocation of $2 million in grants to support groundbreaking research in primary tauopathies.

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Strategies for Pharmacy Success: Navigating the Evolving Healthcare Landscape and Unlocking Alternate Revenue Streams

Drug Topics

Emily Endres, BSPS, vice president of pharmacy at Innovaccer discuss the evolution of healthcare and provides insights into the industry’s next phase.

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NICE blocks Enhertu use after pricing talks break down

pharmaphorum

NICE and pharma groups AstraZeneca and Daiichi Sankyo have been unable to agree on a price for Enhertu in HER2-low breast cancer.

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Slideshow: COVID-19 Cognitive Losses, Pandemic Restrictions Decreased Mortality

Drug Topics

Recent research on COVID-19 examined cognitive loss after an infection, how pandemic restrictions impacted excess deaths, and the increase in physicians experiencing PTSD.

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Biologics contract manufacturing: A comprehensive guide for pharmaceutical companies

pharmaphorum

This comprehensive guide provides pharmaceutical companies with valuable insights into biologics contract manufacturing, including the role of CDMOs and key considerations for successful partnerships.

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ACA exchange enrollees could see steep premium increases if enhanced subsidies expire: KFF

Fierce Healthcare

The enhanced subsidies available for Affordable Care Act plans have been the key to driving massive enrollment growth, and rolling them back would likely lead to a massive spike in premium payments | The enhanced subsidies available for Affordable Care Act plans have been the key to driving massive enrollment growth, and rolling them back would likely lead to a massive spike in premium payments, according to a new report.

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