Thu.Sep 28, 2023

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Glycemic Control in Patients With Type 1 Diabetes Worse Around Holidays, Winter Months

Drug Topics

A new study from Dartmouth College found that patients maintained healthier blood sugar levels from April to September.

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FDA Approves Gepirone Extended-Release for Treatment of Major Depressive Disorder

Pharmacy Times

Gepirone hydrochloride ER (Exxua; Fabre-Kramer Pharmaceuticals Inc) is in a new class of antidepressants, making it the first and only approved antidepressant that selectively targets serotonin 1A receptors.

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More Women Are Using Cannabis to Manage Menopause Symptoms

Drug Topics

A new study found that the most common symptoms that cannabis was used to treat were chronic pain, anxiety, sleep problems, and stress.

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Independent Pharmacy Files Lawsuit Against CVS Health, Caremark, Aetna Based on DIR Fees

Pharmacy Times

The National Community Pharmacists Association said the action was sent into motion by wrongful penalties for Medicare Part D prescriptions, called pharmacy direct and indirect remuneration fees.

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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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Did the government get a bad deal on the Covid-19 boosters?

STAT

WASHINGTON — After Pfizer and Moderna hiked the prices of their Covid-19 vaccines this year, the federal government will now pay nearly three times more than it did previously for each dose. And it’s paying more than countries that did far less to support vaccine development. Health and Human Services Secretary Xavier Becerra glossed over the dramatic increase in the amount the government is paying for vaccines in a public appearance last week, when he got vaccinated at a CVS pharm

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Intervention with Supplemental Creatine Found Effective, Safe for Symptom Reduction After COVID-19 Infection

Pharmacy Times

At a 6-month follow-up, supplemental creatine intervention significantly improved scores for fatigue symptoms and tissue bioenergetics related to COVID-19 infection.

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Pharmacy Focus: Turning the Tide On Obesity - Episode 3

Pharmacy Times

In this final episode, we spoke with Claudia Fox, MD, MPH, FAAP, an associate professor of pediatrics at the University of Minnesota Medical School in Minneapolis.

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Flu, Covid vaccination rates decline, as U.S. health officials make new push for inoculations

STAT

Vaccination rates against flu and Covid-19 have declined since earlier in the pandemic and a new survey suggests significant portions of the U.S. population intend to forgo these vaccines this fall. The survey, conducted by the National Foundation for Infectious Diseases, suggests only about one in five Americans worry that they or someone in their family will contract influenza, Covid, or RSV — respiratory syncytial virus.

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Clinical Overview: Teprotumumab Provides a Breakthrough Treatment for Thyroid Eye Disease

Pharmacy Times

Teprotumumab (Tepezza) is a promising treatment for thyroid eye disease , although its precise mechanism of action remains incompletely characterized.

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She got off dialysis. Her doctor thinks others with acute kidney injury can too

STAT

SAN FRANCISCO — It was during some of the darkest days of the pandemic — November 2020 — when Melissa Lawson, 36, was helicoptered from an emergency room in Santa Rosa, Calif., to a hospital here, her blood so thick with white blood cells doctors thought she might not survive the night. She did, after undergoing a procedure to clear her blood.

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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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Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

Fierce Pharma

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.

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A STAT analysis shows how top drug companies are starting to take action on climate

STAT

This article is adapted from STAT’s exclusive analysis in the STAT Report: “Climate rankings: How top drug companies measure up in combating climate change.” D rug companies are major contributors to climate change, both through direct greenhouse gas emissions and especially through their supply chains. But the pharmaceutical industry has lagged behind others when it comes to understanding and cutting down on its climate impact.

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JAK1 Inhibition May Treat Patients With Food Allergy

Pharmacy Times

Abrocitinib can reduce allergic responses in patients with a peanut allergy by decreasing cytokine activity and maintaining regulatory T cell activation.

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Opinion: Congress could stop free public access to government-funded research

STAT

Have you ever needed to read a research paper, only to find it was locked behind a paywall? Your next step was likely to search on Sci-Hub , an illegal repository created by Kazakh graduate student Alexandra Elbakyan, that provides free access to millions of research papers. While Sci-Hub is controversial, its widespread use points to a crucial question: Shouldn’t taxpayer-funded research be freely and immediately accessible to the public?

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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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Older Women at Greatest Risk of C Diff, COVID-19 Coinfection

Drug Topics

Beyond female gender, comorbidities independently associated with C diff infection in patients diagnosed with COVID-19 included peptic ulcer disease, renal failure, weight loss, diabetes mellitus with complications, and congestive heart failure.

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STAT+: Brigham and Women’s exec opens up about the Dana-Farber Cancer Institute split, and what it means for the future of cancer care

STAT

The severing of ties between two of Boston’s biggest health care giants has placed one of the nation’s largest health care systems in the position of figuring out how, exactly, to fill a new hole in its oncology services, at a time when cancer care is changing rapidly. Earlier this month, Dana-Farber Cancer Institute surprised the medical community and even its partner, Brigham and Women’s Hospital, when it announced that it would end their nearly 30-year collaboration.

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After Amicus scores FDA nod for Pompe disease combo, it's game on with Sanofi

Fierce Pharma

Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. | Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. Nearly a year later, the Philadelphia company has gained its long-awaited green light.

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STAT+: Drug industry payments to eye docs boosted Medicare spending on pricier treatments

STAT

Ophthalmologists who accepted payments from drug companies were less likely to prescribe a cheaper medicine to treat an eye disease that causes blindness in older people, rather than a pair of more expensive alternatives, according to a new study. This led Medicare to spend an additional $643 million during a recent six-year period. Specifically, physicians who received money prescribed Avastin, an older cancer medicine, 28% of the time for combating age-related macular degeneration.

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Opioid Drug Shortages Affect Patients, Health Systems

Pharmacy Times

Pharmacists are experts at juggling shortages of all kinds, however, and L’Altrelli said they are crucial team members regarding opioid access challenges.

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Machine learning could help predict risk of preterm birth using wearables data

STAT

For all their potential to drive changes in health, wearables have struggled to gain a foothold in medicine. The dramatic changes during pregnancy are a fertile ground to test their potential, though — and new research shows how applying machine learning methods to streams of data from wearable devices could be used to understand the mystery of premature birth.

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Conversational AI—fad or the future of patient access?

Fierce Healthcare

Despite large financial investments, digital front door solutions still fall short, leading to patient leakage and additional work for already overburdened staff. | From appointment scheduling to real-time analytics – discover how conversational AI is setting a new standard for patient access.

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CureVac touts 'progress' as German court suspends infringement proceedings against BioNTech

Fierce Pharma

With much riding on its mRNA patent litigation against BioNTech, Germany’s CureVac thinks the case is moving in its favor. | A court in Germany suspended infringement proceedings on four patents at issue in the lawsuit filed by CureVac against BioNTech. Still, CureVac said there's reason to be optimistic its arguments may win out.

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Viome Life Sciences unveils at-home oral, throat cancer detection test

Fierce Healthcare

At-home diagnostics startup Viome Life Sciences has launched a new test to help detect oral and throat cancers. | The test relies on Viome’s proprietary RNA sequencing technology and AI to measure gene expression of the oral microbiome and human cells in each patient’s saliva, which are used to identify early biomarkers associated with oral and throat cancers.

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STAT+: What will Novo’s VC do with its influx of cash? Don’t expect obesity investments

STAT

The Danish pharmaceutical company Novo Nordisk has shepherded all kinds of medical innovation in the 110 years since it was founded. But the booming success of its diabetes and obesity drug is unlike anything executives have seen before. The company’s mid-year operating profit jumped from 37.5 billion danish kroner in 2022 to 48.9 billion danish kroner this year — “probably the strongest growth in the history of the company,” Chief Financial Officer Karsten Munk Knuds

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There's a generational gap in satisfaction with telehealth, J.D. Power finds

Fierce Healthcare

Telehealth continues to enjoy elevated popularity thanks to the COVID-19 pandemic, but significant generational gaps persist in satisfaction, according to a

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Novo Nordisk’s Ozempic gets FDA label update flagging risk of intestinal blockage disorder

Fierce Pharma

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

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STAT+: Pharmalittle: FDA advisers vote overwhelmingly against ALS treatment; weight-loss drugs scrutinized over reports of suicidal thoughts

STAT

Top of the morning to you, and a fine one it is. Despite overcast skies, we are enjoying the hustle-bustle of passing cars, barking dogs, and other signs of life as we rev up for another day. The coffee kettle is firing up — maple bourbon is our choice cup of stimulation — and the backing soundtrack is in order. So time to get cracking.

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PBMs under fire again as Senate introduces new bill

Fierce Healthcare

Following a Senate Finance Committee markup hearing in July, where members voted 26-1 in favor of the Modernizing and Ensuring PBM Accountability (MEPA) Act, Senators Ron Wyden, D-Oregon, and Mike | Legislation targeting pharmacy benefit managers with bipartisan support has been introduced in the Senate.

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J&J's Rybrevant combo bests AstraZeneca's established Tagrisso in key lung cancer study

Fierce Pharma

A highly anticipated head-to-head matchup between a Johnson & Johnson combination and AstraZeneca’s star Tagrisso as a first-line treatment in a subset of non-small cell lung cancer (NSCLC) has | With the trial win, Johnson & Johnson sees potential for its drug combination as the new standard of care in locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.

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Komodo Health unveils new full-stack tool to help clients streamline data analysis

Fierce Healthcare

Komodo Health, a health data company, has announced a new all-in-one offering for healthcare and life sciences companies to generate analytical insights. | MapLab includes robust data science tooling, customizable analytics dashboards and a generative AI analytic assistant.

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Bluebird taps Lonza to boost manufacturing capacity for its gene therapies Zynteglo, Skysona

Fierce Pharma

As bluebird bio’s pricey gene therapy launches take flight, the company is boosting manufacturing capacity with Swiss CDMO Lonza. | Bluebird and Lonza recently amended their production contract for the second time since the deal was announced in summer of 2016. Under the updated deal, Lonza has agreed to increase manufacturing capacity for bluebird’s therapies Zynteglo and Skysona, according to a SEC filing published Wednesday.

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Generative AI-focused biotech startup Evozyne raises $81m

Pharmaceutical Technology

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

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Thayers rolls out moisturizing skin care line

Drug Store News

Utilizing its heritage and scientific expertise, the new line offers consumers a unique and personalized formula that meets the needs of all skin types and tones, the brand noted.

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CymaBay launches study into drug for liver scarring in patients with compensated cirrhosis

Outsourcing Pharma

A study to evaluate the effect of seladelparm, a small molecule treatment by CymaBay Therapeutics, Inc. on patients with cirrhosis was announced this month (September 21).

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