Wed.Sep 28, 2022

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Supporting the Next Era of Independent Pharmacies in the US & Abroad

Drug Topics

The future of independent pharmacy requires the combination of what makes independent pharmacy special and the digital landscape found elsewhere in retail.

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Genomic Testing Framework for Chronic Kidney Disease Continues to Grow

Pharmacy Times

Investigators combine research discovery with technological development to determine whether the role of genomics in nephrology should remain with subspecialists or be integrated into general nephrology.

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Where caregiving is a family affair, Alzheimer’s places a heavy burden on children and spouses

STAT

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

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Expert: Alcohol Dependence Is an Epidemic, Yet Treatments Exist

Pharmacy Times

Pharmacists play an important role in the recovery journey for patients who decide medication assisted treatment is right for them.

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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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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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Dapagliflozen May Decrease Fatal Risks of Heart Failure Associated With Higher Ejection Fraction

Pharmacy Times

For patients suffering from a higher left ventricular ejection fraction, a sodium-glucose cotransporter 2 inhibitor could decrease risk of hospitalization or death from heart failure.

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Pharmacy Focus: On The Shelf - All About Migraine

Pharmacy Times

On this week's episode, host Joanna speaks with Charlie Conway, PhD, chief scientific officer at Biohaven Pharmaceuticals about migraine function, care, and treatment.

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Adjustments in Drug Coverage Criteria in Health Plans Based on New Evidence

Drug Topics

However, researchers found that only a small percentage of plans use available real-world evidence studies and economic evaluations in their coverage policies.

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Clinical Overview: Treatment Options for Prostate Cancer

Pharmacy Times

There were approximately 250,000 new cases of prostate cancer identified in the United States in 2021, which is considered approximately 13% of all cancer cases.

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In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices

STAT

The Food and Drug Administration on Tuesday published a list of artificial intelligence tools that should be regulated as medical devices, in some cases appearing to expand its oversight of previously unregulated software products. In a new final guidance for industry, the agency specified that tools designed to warn caregivers of sepsis, a life-threatening complication of infection, should come under regulatory review.

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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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Pharmacy Focus: Student Edition - Communication Skills for Pharmacy Students

Pharmacy Times

We spoke with Brandon Dyson, PharmD, BCOP, co-founder of TL;DR Pharmacy, to hear about this unique resource for pharmacy students.

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New study sees possible link between aluminum in childhood vaccines and risk of asthma, but caveats abound

STAT

A new study suggests there may be a link between aluminum used in vaccines that are given to young children in the first two years of life and the risk of developing asthma before age 5. The findings are preliminary and both the authors and others who have studied the data urge caution in the interpretation of the results. Based on the findings, the possible association needs to be further explored, said the authors, who nonetheless are worried that in an era of rampant vaccine misinformation an

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Study: Many Cardiovascular Emergencies Related to Poorly Controlled High Blood Pressure

Pharmacy Times

Study finds that 13% of all heart-related emergency department visits were related to essential hypertension.

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STAT+: Top FDA official acknowledges agency’s slow process for reviewing health app updates

STAT

The Food and Drug Administration’s approach to reviewing updates to software products is far slower than consumers have come to expect for apps, a top agency official acknowledged Tuesday. Unlike many commonly used apps, which are frequently updated as developers fix bugs and add new features, updates to regulated digital health products often require a lengthy review.

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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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NACDS shares remarks on White House Conference on Hunger, Nutrition, and Health

Drug Store News

NACDS is engaging in the White House Conference on Hunger, Nutrition, and Health with commitments and recommendations, as well as hosting a satellite event to extend its reach.

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Alzheimer’s treatment slowed cognitive decline in closely watched clinical trial

STAT

An investigational Alzheimer’s disease treatment from Biogen and Eisai slowed the rate of cognitive decline by 27% in a clinical trial, the companies said Tuesday, meeting the goals of a closely tracked study and strengthening the drug’s case for approval as early as January. The positive result is welcome news for the millions of people living with Alzheimer’s and a big win for Eisai and Biogen, giving the companies a potential blockbuster product in the intravenous medicin

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Single caffeine genotype associated with longer prostate cancer survival

Hospital Pharmacy Europe

A caffeine genotype in men who drink higher amounts of coffee is associated with a longer prostate cancer specific survival time. A single caffeine genotype has been shown to be associated with a longer prostate cancer specific survival among men who drink higher amounts of coffee in comparison to other genotypes, according the findings of a study by an international team of researchers.

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Opinion: Medicare needs to cover the full spectrum of care for substance use disorders

STAT

Imagine if Medicare covered treatments for stage 1 or stage 4 cancers, but nothing in between. Absurd, right? Yet that is how Medicare approaches treatment for substance use disorders for its 64 million beneficiaries. This federal health insurance program currently pays for only the least intensive level and most intensive level of substance use care, denying millions of people access to other forms of evidence-based and lifesaving treatments, such as intensive outpatient and residential treatme

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Practical Recommendations for Accelerating Cell and Gene Therapies

PharmExec

Wednesday, September 28, 2022, 11 am ET Join this webinar to hear industry thought leaders discuss issues that impede cell and gene therapy development. They will cover new approaches for expanding viral vector manufacturing capacity with appropriate quality, share recommendations for streamlining clinical trial design and process development, explore opportunities for adapting the regulatory framework for cell and gene therapy technologies, and examine innovative pricing and contracting models.

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Opinion: Listen: How the Dobbs decision could affect how and where clinical trials are conducted

STAT

The Supreme Court’s decision to overturn Roe v. Wade opened the door to allow states to ban or severely restrict abortion. But as biotech CEO Aoife Brennan and her colleagues are coming to realize, it will also affect how — and perhaps where — clinical trials are conducted. Pregnancy tests are an important, and sometimes required, part of clinical research, a way to ensure that an experimental drug does not harm a fetus.

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Tumour-infiltrating lymphocyte therapy in advanced melanoma superior to ipilimumab 

Hospital Pharmacy Europe

Tumour-infiltrating lymphocyte therapy gave superior progression-free survival compared to ipilimumab in patients with advanced melanoma. Tumour-infiltrating lymphocyte therapy (TILT) gave rise to superior progression-free survival in comparison to immune checkpoint inhibitor therapy with ipilimumab in a phase 3 trial of patients with advanced melanoma according to the results of a study presented at the European Society for medical Oncology (ESMO) Congress by Dutch researchers.

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Google’s hospital play, Optum’s data shakeup, & the call for more telehealth oversight

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. Google’s wearables plan takes shape. If you’ve been wondering how the tech titan planned to blend  Fitbit  with its analytics business,  Mario’s got you covered.

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NACDS shares remarks on White House Conference on Hunger, Nutrition, and Health

Drug Store News

NACDS is engaging in the White House Conference on Hunger, Nutrition, and Health with commitments and recommendations, as well as hosting a satellite event to extend its reach.

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Medicinal cannabis monograph proposed by US Pharmacopeia

European Pharmaceutical Review

The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. The proposed cannabis monograph provides scientifically validated methods, information on physical reference standards and acceptance criteria to establish the identity of cannabis chemotypes and content of cannabinoids and terpenes, as well as setting l

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Disparities in Public Access to Vaccines Across Patient Demographics

Drug Topics

Key opinion leaders discuss disparities across varying patient demographics concerning access to vaccines.

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HPLC-MS/MS for NDMA impurity determination in sartans

European Pharmaceutical Review

In a study published in the Microchemical Journal , investigators outlined the development and validation of a HPLC-MS/MS (high-performance liquid chromatography-mass spectrometry) for the determination and quantification of N -nitrosodimethylamine (NDMA) in olmesartan medoxomil. The method was able to detect, separate and quantify NDMA in the active pharmaceutical ingredient (API), manufactured tablets and marketed tablets.

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Why precision medicine could be the next frontier in treating autism

PharmaVoice

Swiss-based Stalicla is banking on an AI-driven precision medicine discovery platform to deliver needed therapies in the autism space.

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The NIH on accelerating research using diverse biomedical datasets

pharmaphorum

Martin Mendoza, PhD, director of health equity and health science policy for the All of Us Research Program at the National Institutes of Health (NIH), tells pharmaphorum about the programme and how it will accelerate research for the benefit of all patients. NIH’s All of Us is building an extensive, diverse biomedical dataset to learn how biology, lifestyle, and environment affect one’s health, and to accelerate research and improve personalised medicine options. “The All of U

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Identifying Patient Populations Benefiting Most From Influenza Vaccination

Drug Topics

The expert panel identifies patient populations who can benefit most from influenza vaccination.

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Ahold Delhaize seeks to reappoint CEO

Drug Store News

Ahold Delhaize’s supervisory board will propose the reappointment of Frans Muller as company president, CEO and member of the management board.

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Q&A: Precision for Medicine VP on the present & future of personalized medicine

Outsourcing Pharma

Outsourcing-Pharma caught up with Esther Mahillo, VP of Operational Strategy and Feasibility, Precision for Medicine to talk about advancements in patient enrollment in oncology and rare disease clinical trials.

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La Roche-Posay’s latest acne treatment features antiaging benefits

Drug Store News

Effaclar Salicylic Acid Acne Treatment Serum is formulated to clear acne blemishes while also working to help prevent new ones.

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FDA Approves Gadopiclenol for Contrast-Enhanced Magnetic Resonance Imaging

Pharmacy Times

Gadopiclenol is a macrocyclic gadolinium-based contrast indicated for use in adults and children 2 years of age and older for contrast-enhanced MRI.

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Johnson & Johnson names consumer health business

Drug Store News

Kenvue will come to life through a compelling purpose and a timeless visual brand, the company said.

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