Thu.Jun 08, 2023

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Highlights from ASCO 2023

PhRMA

Last week, I traveled to the American Society of Clinical Oncology’s (ASCO) annual meeting. It’s always an exceptional meeting where the brightest minds in oncology, including researchers, health care providers and industry stakeholders gather to learn about the latest advancements in cancer research and development (R&D).

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Mask Up: How To Protect Your Respiratory System From Wildfire Smoke

Drug Topics

Which masks (if any) serve as the best protection against wildfire smoke, and what do experts say about home appliances like air conditioners?

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Trending Sources

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Patient Case Study: A Rare Neurological Disease Diagnostic Journey

Pharmacy Times

Neuromyelitis optica spectrum disorder is an autoimmune disease characterized by severe attacks of optic neuritis and/or myelitis, leading to possible visual loss, paralysis, cognitive impairment, sensory deficits, bladder dysfunction, and even mortality.

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CMS launches new pilot program to test out value-based primary care in 8 states

Fierce Healthcare

The Centers for Medicare and Medicaid Services aims to advance value-based primary care, especially in rural areas and among underserved populations, with a new pilot project. | The Centers for Medicare and Medicaid Services aims to advance value-based primary care, especially in rural areas and among underserved populations, with a new pilot project.

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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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At-home COVID-19 Test Cue OTC Receives Marketing Authorization from FDA

Drug Topics

The newly approved at-home test was effective in trials, correctly identifying 98.7% of negative and 92.9% of positive samples for individuals with symptoms of upper respiratory infection.

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For providers, consolidation may be key to staying afloat, experts tell Senators

Fierce Healthcare

Consolidation has been the norm across healthcare for some time, and for those in the industry that want to stay independent, watching their peers unite can be intimidating. | Consolidation has been the norm across healthcare for some time, and for those in the industry that want to stay independent, watching their peers unite can be intimidating.

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Sanofi, AstraZeneca's RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Fierce Pharma

Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle. | Seeking to launch their RSV prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.

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AHA: Administrative burdens and payer rates—not hospitals—are to blame for fewer independent physician practices

Fierce Healthcare

Hospital acquisitions of physician practices are primarily being fueled by burdensome administrative requirements, rising expenses and insufficient commercial and public reimbursement rates, the in | The American Hospital Association released a report outlining the workload and expenses they say are driving physicians under their wing. The hospital industry lobbyist also floated major acquisitions by CVS Health and UnitedHealth Group's Optum as more deserving targets for policymakers'

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Sandoz hitches its wagon to biosimilars, predicting $3B in sales from pipeline products over next 5 years

Fierce Pharma

Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline | Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline in revenue every year since 2016. But the slide could end soon as the company projects sales of its pipeline products to add $3 billion to the top line over the next five years, thanks largely to biosimilars.

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Clinical Overview: A Novel Way of Treating Schizophrenia

Pharmacy Times

The estimated cost burden of schizophrenia is more than $150 billion, consisting of direct treatment cost and lost productivity.

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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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ACO sign-ups for 2024 are underway. Policy changes have helped, but more work is needed, experts say

Fierce Healthcare

Phase 1 enrollment in the Medicare Shared Savings Program (MSSP) for 2024 is currently underway, and recent reforms hold promise in attracting new providers into accountable care. | Phase 1 enrollment in the Medicare Shared Savings Program for 2024 is currently underway, and recent reforms hold promise in attracting new providers into accountable care.

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New Study Suggests Symptoms of Insomnia Linked to Increased Risk of Stroke

Pharmacy Times

People with less severe symptoms of insomnia still had a 16% increased risk of stroke compared to people with no symptoms.

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Deal of the week: Strive Health raises $166m to aid kidney health services

Pharmaceutical Technology

Each week, Pharmaceutical Technology’s editors select a deal that illustrates the themes driving change in our sector. The deal may not always be the largest in value, or the highest profile. But it will tell us where the leading companies are focusing their efforts, and why. This new, thematic deal coverage is driven by our underlying Disruptor data which tracks all major deals, patents, company filings, hiring patterns and social media buzz across our sectors.

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Show 1343: Hidden Harms of Herb and Drug Interactions

The People's Pharmacy

Millions of Americans take dietary supplements, and most of us assume that they are safe. While that is probably a reasonable rule of thumb, there are some situations that require more vigilance. In particular, we need to beware of herb and drug interactions. Even your doctor may not know about the hidden harms. How Risky Are Herb and Drug Interactions?

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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+: If AI invents a new medicine, who gets the patent?

STAT

Pharmaceutical and biotech companies are increasingly using artificial intelligence to discover and make drugs and therapeutics. Congress on Wednesday asked the question: Does that mean AI can be an inventor on a patent? AI models can already look for patterns in old clinical trial data, look at images of cells and quantify changes in them, or virtually test whether drug candidates will dock in a certain receptor — all with tools that aren’t that different from Excel or a calculato

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Public Health Matters - Advocating for Patients, Impacting Public Health

Pharmacy Times

Christina Madison speaks with Sandra Leal, PharmD, fromCVS Health, about advocating for patients and how that impacts public health.

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Opinion: Why brain decoding is not mind reading — and why that matters

STAT

Recently, my colleagues and I published a study on decoding language from brain recordings made using functional MRI. Brain decoders are being developed to help restore communication to people who have lost the ability to speak or write. Currently, most brain decoders use recordings from implanted electrodes, and are primarily intended for people with motor system disorders.

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FDA grants orphan drug designation to DTx Pharma’s CMT1A therapeutic

Pharmaceutical Technology

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). DTx-1252 is a fatty acid ligand conjugated oligonucleotides (FALCON) small interfering RNA (siRNA) therapeutic which represses the PMP22 gene in Schwann cells. It induces remyelination of axons to normal levels, increases muscle coordination, agility, mass, grip and strength, and improves electrophysiological measurem

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2023 Pharm Exec Top 50 Companies

PharmExec

With the sales boom from COVID-19 products now in the rear-view, a resetting is underway for those in Pharm Exec’s listing of the top biopharma producers—shifting attention to new Rx roads ahead and the steady strategies needed to navigate a bumpy business terrain.

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STAT+: Study finds supplements of amino acid taurine slow aging in mice and monkeys

STAT

The first clue was blind cats. About 50 years ago, K.C. Hayes, a professor of nutrition at the Harvard School of Public Health, took on the mystery of why some cats experienced rapid deterioration of their vision. The problem, Hayes figured out, was that some brands of cat food lacked an amino acid called taurine, something cats don’t produce themselves.

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The Need for Speed: Reducing Risk, Cost, and Delays for Novel Gene Therapies

ISPE

The Need for Speed: Reducing Risk, Cost, and Delays for Novel Gene Therapies Trudy Patterson Thu, 06/08/2023 - 14:52 iSpeak Blog iSpeak The Need for Speed: Reducing Risk, Cost, and Delays for Novel Gene Therapies Amrit Chaudhuri 8 June 2023 Novel cell and gene therapies are already revolutionizing medicine. These new therapies can modify a patient's DNA and transform their cells into powerful tools for treating a wide range of diseases, from cystic fibrosis and heart disease to diabetes, hemophi

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BMI is starting to plateau in rich Western countries. That doesn’t mean obesity is solved

STAT

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about  The Obesity Revolution. “S oaring obesity rates.” “An alarming surge in BMI.

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4DMT’s CF gene therapy posts early cues for improving patient outcomes

Pharmaceutical Technology

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS). While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the dr

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STAT+: After gene therapy deaths, Astellas brings in potentially safer treatment for muscle disorder

STAT

Astellas Pharma said Thursday it will license and develop a new gene therapy for a devastating muscle disorder, after four boys died in a clinical trial testing an earlier treatment. The hope is that the new therapy will allow researchers to treat the disease, known as X-linked myotubular myopathy, or XLMTM, with much lower doses of the viruses used to shuttle genes into patients’ cells.

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Cardinal Health’s Outcomes merges into Transaction Data Systems

Drug Store News

Cardinal Health's Outcomes business will combine with Transaction Data Systems to offer improved patient engagement and clinical pharmacy solutions.

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FDA advisers recommend approval of monoclonal antibody to protect newborns and young children from RSV

STAT

A Food and Drug Administration advisory committee voted overwhelmingly on Thursday to recommend approval of a monoclonal antibody product to protect newborns and young children from RSV. The Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of nirsevimab — which will be marketed as Beyfortus — in children in the first year of life.

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Shifting to Commercialization

Pharmaceutical Commerce

Sy Pretorius, COO & president of outsourced solutions at Eversana, dives into his new role in the space, after being a veteran in the clinical development sector.

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STAT+: Pharmalittle: FDA commish calls U.S. drug prices ‘too high’; FDA staff says Eisai and Biogen’s Alzheimer’s drug has benefits

STAT

Rise and shine, everyone, another busy day is on the way, although the smoky covering has certainly reduced the number of noisy vehicles that usually pass by at this time of the morning. Nonetheless, there is much to do. So as usual, we are firing up the trusty coffee kettle to brew a cup or three of stimulation. Our choice today is roasted coconut.

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Equality Health rolls out in-home care to address medical, social needs of underserved patients

Fierce Healthcare

There are many patients who struggle to navigate the traditional healthcare system and end up falling through the cracks. | Equality Health, a company that aims to improve access to value-based care for underserved populations, launched a new program to provide in-person and virtual care to patients facing complex medical issues in the convenience of their homes.

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AI insight at BIO, Google and Mayo Clinic’s latest effort, & $13 million for health workforce tech

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.  Psychiatric medications leave many people with mental illness behind. Can AI change that?

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Multivitamins improve memory, slow cognitive aging in older adults, study finds

Drug Store News

The COcoa Supplement and Multivitamin Outcomes Study included two separate clinical trials testing multivitamin supplementation on changes in cognitive function.

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Fierce Pharma Asia—Eisai and Biogen's Leqembi progress; AZ and Daiichi's Enhertu data; Samsung Biologics' manufacturing deal

Fierce Pharma

Fierce Pharma Asia—Eisai and Biogen's Leqembi progress; AZ and Daiichi's Enhertu data; Samsung Biologics' manufacturing deal zbecker Thu, 06/08/2023 - 19:34

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Inside Beauty: Celebrity Hairstylist Janel Sealy Smith shares styles for day or night

Drug Store News

Janel Sealy Smith, hairstylist with Kiss Colors & Care, shares how consumers can easily elevate and experiment with a variety of styles while protecting their tresses.

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Yes, biopharma still has a reputation problem. These leaders are looking for solutions

PharmaVoice

Negative news is breaking down the public’s perception of the biopharma industry — but leaders around the industry have some ideas to fix it.

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