Sat.Dec 17, 2022 - Fri.Dec 23, 2022

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Artificial Intelligence Applications in Education and Pharmacy Practice

Pharmacy Times

By interpreting and applying the data provided by algorithms, pharmacists are uniquely equipped to guide development of more patient-centered care.

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What you should know about real-world evidence and drug development

PhRMA

Recently, industry leaders, regulators, academics, data partners, and patient advocates gathered in Washington, D.C., to discuss using real-world data and real-world evidence for regulatory decision-making. The discussion explored emerging analytical methodologies to address the challenge of mitigating sources of bias and confounding variables that come up in nearly all sources of real-word data.

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Phase 3 Trial Shows Benefit of Empagliflozin for Pediatric Type 2 Diabetes

Drug Topics

Eli Lilly and Company and Boehringer Ingelheim announced their SGLT2 inhibitor, empagliflozin, was associated with statistically significant reductions in HbA1c relative to placebo therapy among a population of pediatric patients with type 2 diabetes in the DINAMO trial.

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‘One needs to feel safe’: Racism can put sleep — and its health benefits — out of reach

STAT

Lots of people struggle to get enough sleep — and the responsibility for fixing the problem tends to fall on the individual. Experts offer advice like reducing screen time, exercising more, or just going to bed earlier in the evening. But many restless nights can’t be solved with blackout curtains, ear plugs, or other typical suggestions.

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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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Experts Warn of Spread of Lung Infection-Causing Fungi

Pharmacy Times

Traditionally, endemic fungi are characterized by geographical distribution, however, disease-causing fungi may infect people beyond these havens.

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UK digital health project aims to tackle dysfunctional breathing

pharmaphorum

A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.

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Moderna and UK government sign deal to establish mRNA facility

Pharmaceutical Technology

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.

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Study Results Suggest Exercise, Mindfulness Do Not Boost Cognitive Function in Older Adults

Pharmacy Times

Although physical activity and the practice of being present in the moment are associated with many benefits, analysis shows that neither led to measurable improvements in brain health.

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Moderna finalises plans for UK mRNA vaccine manufacturing centre

European Pharmaceutical Review

Moderna, Inc. has finalised a strategic partnership with the UK government to establish a state-of-the-art mRNA vaccine research, development, and manufacturing facility in the UK. This milestone follows the agreement in principle between Moderna and the UK Government, announced in June 2022. The Moderna Innovation and Technology Centre (MITC) is intended to provide access to a UK-made supply of COVID-19 jabs.

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CBD May Help Mitigate Opioid Withdrawal Symptoms

Drug Topics

In the midst of an opioid epidemic, CBD may help patients experiencing opioid withdrawal symptoms find relief.

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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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Lilly and ProQR to expand genetic medicine development agreement

Pharmaceutical Technology

Eli Lilly and Company has expanded a licencing and partnership agreement with ProQR Therapeutics to discover, develop and market new genetic medicines. The companies entered the initial agreement in September last year. This alliance is utilising the Axiomer ribonucleic acid (RNA) editing platform of ProQR to address ailments affecting the liver and nervous system.

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For the First Time, An Anti-Cancer Vaccine May Be Viable, Effectively Reduce Cancer Risk

Pharmacy Times

An anti-cancer vaccine that is now in clinical trials shows promise as a preventative agent. However, experts are unsure when it will be widely available.

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Opinion: Lessons learned from the deadly combination of sepsis and Covid-19

STAT

Sepsis, a deadly overreaction of the immune system to infection, has befuddled clinicians and researchers for decades. Covid-19 made things worse. The early signs and symptoms of sepsis mimic those of both Covid-19 and influenza: fever, chills, dry cough, shortness of breath, fatigue, muscle or body aches, sore throat, nasal congestion, runny nose, and more.

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New Approaches in Psoriasis and Psoriatic Arthritis Treatment

Drug Topics

Understanding the relationship between psoriasis and psoriatic arthritis can help.

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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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UK, Moderna formalise 10-year vaccines alliance

pharmaphorum

Construction will start early next year of a new manufacturing centre in the UK with the capacity to produce 250 million vaccine doses per year, the centrepiece of a 10-year alliance between the government and US biotech Moderna. The government said today it has finalised the partnership – agreed in principle earlier this year and estimated to be worth in the region of $1.2 billion – although it is not revealing the financial details, as these are “commercially sensitive.” The overar

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Artificial Intelligence Shows Promise in Detection of Anxiety Disorders, Depression

Pharmacy Times

Investigators establish that audio and/or facial video features have been most analyzed by machine learning, followed by electroencephalography signals.

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Opinion: Reducing the threat of vaccine-preventable diseases starts with kids

STAT

Americans have been warned — again — about lax attention to routine vaccinations. This time the warning comes from measles , an age-old, vaccine-preventable disease, with an outbreak in central Ohio among nearly 80 children and counting, almost all of them unvaccinated against measles. Once well-controlled in the U.S., which has maintained “measles elimination status” for almost 20 years, this disease may no longer be a rarity as millions of children in the U.S. are m

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FDA Approves First-In-Class Twice-Yearly Treatment for HIV

Drug Topics

Lenacapavir was approved with the FDA's Breakthrough Therapy Designation.

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EMA CHMP recommends Moderna’s Covid-19 booster for children

Pharmaceutical Technology

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) booster for usage in children aged six to 11 years. The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination.

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Study: Travel Times Are Still a Major Obstacle for Women Seeking Breast Cancer Screening

Pharmacy Times

In 10 states, the data showed more than 26% of women had limited accessibility to mammography, primarily in the Rocky Mountains and the South.

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Flu activity in the U.S. continues to decline after early surge

STAT

Flu activity across the United States continues to decline, though it remains at high levels in most parts of the country, the Centers for Disease Control and Prevention reported Friday in its weekly influenza update for the week ending Dec. 17. The percentage of people seeking medical care for influenza-like illness dropped for the third straight week, and hospitalizations due to flu declined for the second week in a row.

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FDA approves Adstiladrin as first gene therapy for NMIBC

pharmaphorum

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours. Bladder cancer is one of the more common forms of cancer.

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Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

Fluoxetine was approved to treat depression 35 years ago. Since then, there have been few breakthrough innovations in treating neuropsychiatric diseases such as anxiety, depression, substance use disorders (SUDs), and post-traumatic stress disorder (PTSD). For many indications, progress has been incremental. Psychedelic research, in particular, is gaining momentum. .

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Intravenous Immunoglobulin May Improve Severe OCD in Children

Pharmacy Times

Treatment observably eased obsessive-compulsive disorder symptom severity in young patients, however, symptoms still caused students to be absent from school at least 2 days every month.

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Opinion: Specialized centers can help realign the U.S.’s moral compass for sickle cell disease

STAT

Even as the United States has made commitments to health as a human right and reversing health disparities and has invested significantly in orphan diseases, it continues to overlook sickle cell disease (SCD), the most common inherited blood disorder worldwide, which affects more than 100,000 Americans , most of whom are Black or Hispanic American. As hematologists who take care of people with sickle cell disease , it’s disheartening to see this condition receive only a fraction of the at

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2023 forecast: Amid dwindling COVID relief funds, rural hospitals face a 'fiscal cliff'

Fierce Healthcare

2023 forecast: Amid dwindling COVID relief funds, rural hospitals face a 'fiscal cliff'. agliadkovskaya. Mon, 12/19/2022 - 14:42.

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Could ketamine-assisted therapy help treat alcoholism?

European Pharmaceutical Review

A new £2.4 million Phase III trial will determine if ketamine-assisted therapy can help those with severe alcohol use disorder to stay off alcohol for longer. Led by the University of Exeter and funded by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), “[t]his is the largest trial of its kind in the world and builds on our earlier, smaller positive trial,” stated Professor Anne Lingford-Hughes, Professor of Addiction Biology at Imperial College

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NIH Awards $7.8 Million for Antibiotic Study of Patients With Emphysema, HIV

Pharmacy Times

The National Institute of Health’s grant funds a phase 2 clinical trial of doxycycline in a large group of individuals with the 2 conditions who are smokers or used to smoke.

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Every kick, a reminder: in post-Roe California, a painful wait before ending a wanted pregnancy

STAT

This is part of a series of snapshots from post-Roe America. H e loved peaches. He loved ice cream. He loved blueberry waffles, evenly gridded, which she’d pulled from the crinkly package in the freezer and popped in the toaster to eat on her way to work. L. knew all this from the way he moved, the way he made her sick. His name was Kai. He was due on December 18.

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Pfizer, Sanofi settle first California Zantac case slated for trial: report

Fierce Pharma

Pfizer, Sanofi settle first California Zantac case slated for trial: report. zbecker. Thu, 12/22/2022 - 12:38.

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mRNA therapeutics: a limitless revolution in medicine

European Pharmaceutical Review

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. mRNA technologies have emerged as an innovative and effective approach to developing new drugs that can potentially transform existing therapies or target difficult‑to‑treat indications including respiratory, cardiac, metabolic and autoimmune diseases, as well as cancer.

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Study: Intermittent Fasting Shows Link to Diabetes Remission

Pharmacy Times

TD2 remission is defined as a hemoglobin A1C level of less than 6.5% at least 1 year after stopping medication, investigators say.

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From telehealth to Medicare cuts: Here are the health policies in Congress' $1.7T omnibus

Fierce Healthcare

From telehealth to Medicare cuts: Here are the health policies in Congress' $1.7T omnibus. rking. Tue, 12/20/2022 - 10:29.

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U.S. life expectancy falls for second straight year as drug overdose and Covid deaths take toll

STAT

Life expectancy for Americans fell for the second straight year in 2021, largely driven by increases in deaths from Covid-19 and drug overdoses, according to new data from the Centers for Disease Control and Prevention. A baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996.

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