Tue.May 09, 2023

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4 key facts on medicine prices and spending

PhRMA

This week, policymakers on Capitol Hill will continue to discuss the cost of lifesaving medicines and how to make them more affordable for Americans. It’s an important discussion that the biopharmaceutical industry believes we need to have. A new treatment or cure can’t improve a patient’s life if they can’t get it. As the conversation continues in Congress, IQVIA is out with a new and timely report on medicine prices and spending.

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Current TRD Treatment Model: Part 1

Drug Topics

The panelists provide an overview of the treatment model for treating patients with treatment-resistant depression.

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Diversity and Representation in Pharmacy

Pharmacy Is Right For Me

Pharmacy is an ever-evolving field that offers great career opportunities for people of all backgrounds. However, for people of color, there are some unique benefits to consider. Diversity in pharmacy is important for increasing representation in the field. Diversity is essential in any industry, and the pharmacy field is no exception. As a pharmacist, you’re a vital member of the healthcare team and your role in patient care is critical.

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Myasthenia Gravis Patients Fare Better With COVID-19 When Vaccinated

Drug Topics

Unvaccinated patients who were older at MG onset and at SARS-CoV-2 infection had more severe cases.

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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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Once-Daily Oral Pill for Plaque Psoriasis Shows Promise

Pharmacy Times

Deuvacracitinib (Sotyktu), which the FDA approved in September 2022, is a first-of-its-class tyrosine kinase 2 inhibitor and a member of the Janus kinase family.

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The emergence of tranq amidst the fentanyl crisis

Pharmaceutical Technology

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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Ginkgo and Boehringer partner to develop hard-to-treat disease therapies

Pharmaceutical Technology

Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases. The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. They will also use the metagenomic sequence database of Ginkgo Bioworks which comprises more than three terabases of sequence data and over two billion protein sequences fr

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Anti-Poverty Programs Reduce Disparities in Hippocampal Development in Children

Pharmacy Times

The impact that socioeconomic inequities can have on a child’s hippocampal volume may have implications for their success and experience pursuing educational endeavors.

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Can GLP-1 obesity therapy restore NK cell function?

European Pharmaceutical Review

NK cell functionality was restored in participants following gold-standard pharmacological obesity GLP-1 analogue treatment, according to a study published in Obesity. This may contribute to the benefits reported with these medications in people with obesity, the data showed. Reducing the risk of cancer in obese individuals Boosting function of NK cells Previous research has found that people with obesity are at higher risk for developing cancer.

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‘Warm’ Autopsy Suggests Metastatic Melanoma Has Different DNA Landscape Than Early-Stage Disease

Pharmacy Times

Findings may offer insight into new strategies to tackle skin cancer in patients already treated with a prior line of therapy.

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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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Breast cancer screening should begin at 40, not 50, federal health panel recommends

STAT

The United States Preventive Services Task Force on Tuesday created new draft guidelines recommending all women begin screening mammography at age 40, a decade earlier than previous guidelines, and continue screenings every other year until age 74. The change is bound to be controversial, adding fresh fuel to a long-standing debate around when people should begin breast cancer screening, how often they should do it, and if specific groups, such as Black women , ought to be screened differently.

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Expert: Hemp-Derived CBD Products ‘Are Simply Not Regulated, That's The Problem’

Pharmacy Times

With or without US federal regulation, CBD companies should provide consumers with more transparent information about their products.

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Opinion: Health care coaches are the next big thing. They’re also completely unregulated

STAT

John, a hypothetical middle-aged man, is told at his job about a new workplace wellness initiative that, among other things, offers two free sessions with a health coach. John immediately jumps at the chance — his primary care doctor had even suggested he consider working with a health coach. The health coach recommends a litany of lifestyle changes including diet, exercise, and supplements, which John conscientiously implements.

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How Integrating Clinical Trials Into Private Practice Can Benefit Both Patients, Physicians

Pharmacy Times

Having scheduled check-ins for an ongoing trial arguably helps patients feel more informed and in charge of their health.

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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+: What to know about a pivotal FDA hearing on Sarepta’s gene therapy for Duchenne

STAT

On Friday, a committee of advisers to the Food and Drug Administration will meet to discuss Sarepta Therapeutics’ closely watched experimental gene therapy for Duchenne muscular dystrophy. It will be the first FDA advisory panel hearing for a Duchenne drug from Sarepta since 2016, when hundreds of patients and family members traveled to the FDA campus in Maryland to plead with experts to authorize an earlier therapy from the company despite limited evidence.

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Study: Unawareness of Memory Decline Associated With Future Progression in Older Adults

Pharmacy Times

Lack of awareness, or anosognosia, may be present up to 2 to 3 years before an Alzheimer dementia diagnosis is made.

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Opinion: The IRA’s nonsensical distinction between small- and large-molecule drugs

STAT

Thanks to advances in science, notably the completion of the Human Genome Project 20 years ago, we are able to treat diseases more effectively than ever before. Researchers have more sophisticated tools not only to identify new drug targets, but also to make drugs to hit those targets. A wide variety of therapeutic agents help make these drugs, including chemically synthesized small molecules; larger molecules made of amino acids like peptides, proteins, and antibodies; and nucleic acids like RN

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Review Finds Continuation is Key Issue in PrEP Programming for Adolescent Girls, Young Women

Pharmacy Times

Evidence suggest better outcomes results when a program is responsive to the significant needs of this population.

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STAT+: Q&A: Sen. Sanders on insulin costs and his committee’s generic drug kerfuffle

STAT

WASHINGTON — Wednesday’s Senate hearing on high costs for insulin “is not the end” of Sen. Bernie Sanders’ plans for drug pricing interrogations, he told STAT in an interview. But it will be a show. The Vermont independent is bringing executives from drugmakers Eli Lilly, Novo Nordisk and Sanofi, along with pharmacy benefit managers Express Scripts, OptumRx and CVS Health, to appear before the Senate Health, Education, Labor & Pensions Committee this week.

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Science Summarised: Potential New Drugs for Hearing Loss

NF2 BioSolutions

It’s NF2 science, but summarised! — About 12 million people in the UK live with hearing loss, including people with NF2-related Schwannomatosis (NF2-SWN or NF2). For some people, hearing loss is associated with communication difficulties, poor social interaction, unemployment, anxiety and depression. Hearing loss resulting from damage to the inner ear (for example vestibular schwannoma tumour growth – see diagram below) is known as sensorineural hearing loss (SNHL) which is gen

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Why health care needs to shift its thinking on AI, FDA’s health tech progress, & the latest on Carbon’s insurance dust-up

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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Covid-19 global health emergency over, but threat remains, says WHO

Hospital Pharmacy Europe

The global health emergency posed by Covid-19 is over, the World Health Organization (WHO) has declared, while also stressing that the disease remains a ‘global health threat’. For over a year, the Covid-19 pandemic had been ‘on a downward trend’, due to population immunity increasing from vaccination and infection, mortality decreasing and the pressure on health systems easing, said Dr Tedros Adhanom Ghebreyesus, director-general of the WHO.

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An artist uses the canvas to make sense of her partner’s illness, and her own

STAT

For Lauryn Welch, a 32-year-old artist with roots in New Hampshire, painting and chronic illness were synchronized revelations. Learning her longtime partner, Samuel Geiger, had a connective tissue disorder called hypermobile Ehlers-Danlos syndrome, led her to the canvas. She needed an outlet, a way of making sense of what her partner was feeling, and the brushes helped.

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Product Lifecycle Innovation through Cross-Fertilising Methodological Enablers across Biological Modalities

ISPE

Product Lifecycle Innovation through Cross-Fertilising Methodological Enablers across Biological Modalities Trudy Patterson Tue, 05/09/2023 - 12:04 iSpeak Blog iSpeak Product Lifecycle Innovation through Cross-Fertilising Methodological Enablers across Biological Modalities Phillip R. Smith, PhD Christoph Herwig, PhD 9 May 2023 Are you interested in developing a new bioproduct and attracted by the incredible potentials of new modalities like ATMPs, Cell and Gene Therapies, AAVs, oligonucleotides

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STAT+: ‘Hard to catch up’: FDA commissioner on regulating new digital health tools

STAT

WASHINGTON — Digital health tools are developing faster than the Food and Drug Administration is able to regulate them, FDA Commissioner Robert Califf acknowledged this week.  “I think we’re behind, and it’s going to be really hard to catch up,” Califf said in a speech Monday at the National Health Council’s patient engagement symposium.

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Metformin and Doxycycline Found Equally Effective in Treatment of Acne

Drug Topics

Although both drugs led to a reduction in severity, doxycycline was more efficacious in reducing inflammatory lesions.

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STAT+: Gilead defeats federal government in closely watched battle over patents for HIV prevention pills

STAT

A federal jury handed a major win to Gilead Sciences on Tuesday in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills. The jury decided Gilead did not infringe on patents held by the Centers for Disease Control and Prevention and, in fact, that the agency’s patents were invalid. The CDC helped fund academic research into HIV prevention that later formed the basis for the pills.

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Baxter to sell BPS business to Advent and Warburg Pincus for $4.25bn

Pharmaceutical Technology

Baxter International has signed a definitive agreement to sell its BioPharma Solutions (BPS) business to private equity investor Advent International and growth investor Warburg Pincus, in a deal valued at $4.25bn in cash. BPS offers parenteral delivery systems, sterile contract manufacturing solutions and customised support services to the pharma and biotech industries.

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STAT+: What FDA mandate? Sun Pharma halts shipments from a plant with a troubled history

STAT

In a fresh sign of quality-control problems in the Indian pharmaceutical industry, the Food and Drug Administration decided that a Sun Pharmaceuticals facility failed to comply with a legal mandate to correct serious shortcomings. As a result, the company has halted exports from the plant to the United States. At issue is a facility Sun bought eight years ago from Ranbaxy Laboratories, which was a poster child for lax manufacturing standards in India.

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Watch DSN: Kroger Health tackles demographic representation gap in clinical trials

Drug Store News

DSN interviewed Dr. Marc Watkins, chief medical officer at Kroger Health, about how the company can help improve therapeutic solutions in the clinical trial space.

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Scripps ransomware post-mortem reveals significant ripple effects for nearby hospitals

Fierce Healthcare

Scripps ransomware post-mortem reveals significant ripple effects for nearby hospitals aburky Tue, 05/09/2023 - 16:00

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This ‘hot-blooded’ CEO is aiming to transform the way burn victims heal

PharmaVoice

Cutiss CEO Daniela Marino is funneling her bold personality and expertise in regenerative medicine into a startup developing bioengineered skin grafts.

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Expert: Specialty Drug Pipeline Remains Robust, With Exciting New Drugs On the Horizon

Pharmacy Times

Approximately 43 total specialty drugs come to the market each year, on average.

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Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion

Fierce Pharma

Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion zbecker Tue, 05/09/2023 - 10:51

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