Sat.May 13, 2023 - Fri.May 19, 2023

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Avoid These Independent Pharmacy Marketing Pitfalls

Drug Topics

Marketing costs money, so be sure to spend wisely.

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PBMs Face Criticism From Many Angles

Drug Topics

The National Community Pharmacists Association now has plenty of allies in its fight with the pharmacy benefit managers.

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There Are Food, Drug Interactions Older Adults Should Be Aware Of As They Age

Pharmacy Times

Good practice for older adults is that calories should go down while nutrient intake goes up as they age.

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STAT+: In its first tough test, CRISPR epigenome editing cuts cholesterol levels in monkeys

STAT

A defanged form of CRISPR, which doesn’t slice or nick DNA, but rather alters the epigenome — the layers of chemical coding that sit on top of DNA and control the activity of genes — has aced its first substantive test. When researchers used CRISPR “ epigenome editing ” to dial down a cholesterol-associated gene in monkeys, the animals’ blood levels of heart-disease-causing LDL, or “bad” cholesterol, plummeted by more than 50%, Jennifer Kwo

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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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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.

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Are We Close To A Universal Flu Vaccine?

Drug Topics

Seasonal influenza kills hundreds of thousands of people every year due to a constantly changing virus and highly inefficient vaccine production. A universal flu vaccine could deal with the first problem, and mRNA technology with the second.

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Depression hits new high among Americans, per survey

STAT

WASHINGTON — More than a quarter of American adults are depressed, a 10% surge from nearly a decade ago, according to the latest Gallup survey. The data come as the Biden administration tries to overhaul mental health care costs and boost the number of health care workers licensed to practice behavioral health care. Congress in this year’s budget also allotted hundreds of millions of dollars to mental health care grants and programs, many of them trained on children or substance mi

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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

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Medical Cannabis Associated With Improvements in Health-Related Quality of Life

Drug Topics

Balanced products showed greater improvements compared to either CBD-dominant or THC-dominant products.

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Novavax’s COVID-Influenza Combination Vaccine Demonstrates Reassuring Preliminary Safety Profile

Pharmacy Times

Investigators of the phase 2 study also found a comparable reactogenicity to the individual influenza and COVID-19 vaccines from Novavax or authorized vaccine comparators.

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Study: Giving an antibiotic to household contacts of people with leprosy slashes chances of spread

STAT

When someone has leprosy, people who live in the same household face the highest odds of contracting the infection. But in a new trial, providing those contacts with a single dose of an antibiotic typically used to treat tuberculosis drastically reduced that risk, researchers reported Wednesday. The trial, which took place in China, corroborates the idea of giving close contacts an antibiotic as a way to reduce the likelihood that the disease spreads, experts said.

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Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health

Fierce Healthcare

Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health dmuoio Tue, 05/16/2023 - 12:40

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Activity “Snacking” Can Benefit Individuals With T1D

Drug Topics

Doing small spurts of exercise throughout the day provide numerous benefits.

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Pegfilgrastim Biosimilar for Treatment of Neutropenia Launches

Pharmacy Times

Pegfilgrastim-pbbk is a leukocyte growth factor developed to reduce the onset of infection in patients with non-myeloid malignancies administered myelosuppressive anticancer medications associated with a clinically significant rate of febrile neutropenia.

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‘Stunning’ change to United’s colonoscopy coverage roils physicians and patients

STAT

When gastroenterologists learned in March that UnitedHealthcare plans to barricade many colonoscopies behind a controversial and complicated process known as prior authorization, their emotions cycled rapidly between fear, shock, and outrage. The change, which the health insurer will implement on June 1, means that any United member seeking surveillance and diagnostic colonoscopies to detect cancer will first need approval from United — or else have to pay out of pocket.

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Cybersecurity attack against Amazon-owned online pharmacy PillPack exposed user health data

Fierce Healthcare

Cybersecurity attack against Amazon-owned online pharmacy PillPack exposed user health data aburky Fri, 05/19/2023 - 16:16

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News Roundup: May 15 to May 19

Drug Topics

Your weekly roundup of the latest news from Drug Topics®.

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Role of Live-JSLM in Treating Recurrent CDI

Pharmacy Times

Joseph Reilly, BS, PharmD, BCGP, and Andrew Skinner, MD, discuss the potential benefits of using live-jslm early on to treat CDI, as well as the implications of this new treatment.

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After decades of neglecting women athletes, sport and exercise medicine is finally catching up

STAT

When cyclist Alison Tetrick joined the sport’s professional ranks, she received the perks that come with the job — new bikes and clothing included. But she could never get comfortable on the bike saddles. After several years, Tetrick suffered so much damage to her genital area that she eventually resorted to surgery to trim excess skin from her labia.

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Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid

Fierce Pharma

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30

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Commercial payers frequently delayed paying out providers' claims in Q1, report finds

Fierce Healthcare

Commercial payers frequently delayed paying out providers' claims in Q1, report finds dmuoio Fri, 05/19/2023 - 15:44

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Regular Cardio Exercise Can Significantly Reduce Risk of Death From Flu, Pneumonia

Pharmacy Times

At least 150 minutes per week of moderate intensity aerobic activity, or 75 minutes of vigorous intensity aerobic activity found to improve outcomes in patients with flu or pneumonia.

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STAT+: Pear Therapeutics sold for parts at $6 million auction

STAT

Four different companies agreed to buy the assets of Pear Therapeutics at auction on Thursday morning after the digital health company filed for bankruptcy last month. Click Therapeutics, Welt Corp, Harvest Bio, and Nox Health Group each acquired bits of the company for $6.05 million, far short of the $32 million in debt Pear carried. A hearing to approve the sale will be held on May 22.

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Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Whilst there is a range of FDA-approved biologics for Crohn’s disease, Rinvoq is the first approved oral product for the moderate to severe type of the disease.

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Walgreens reaches $230M opioid settlement with San Francisco

Drug Store News

In a statement, Walgreens said it "disputes liability" and did not admit fault, but settling allows it to focus on patients, customers and communities.

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Expanded Testing Found to Improve Diagnosis of Respiratory Syncytial Virus

Pharmacy Times

Study finds that a more accurate estimate of the burden of RSV disease will facilitate appropriate decision making regarding the use of preventive interventions, such as vaccination.

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STAT+: Biden drug czar to summon naloxone makers to White House to discuss pricing

STAT

WASHINGTON — The White House is summoning naloxone manufacturers for a roundtable focused on the medication’s price, the Biden administration’s top drug policy official told STAT. The move would represent the White House’s most concrete action to date to address the price of naloxone , a medication used to reverse opioid overdoses.

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Relieving the itch - new treatment for CKD-associated pruritus in adults on haemodialysis

Outsourcing Pharma

A small molecule drug has been recommended by Englandâs National Institute for Health Care and Excellence (NICE) for the treatment of adults with moderate to severe chronic kidney disease (CKD)-associated pruritus in adult patients on haemodialysis.

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AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race

Fierce Pharma

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21

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2022 ACC Consensus on Role of Nonstatin Therapies for LDL-Cholesterol Lowering

Pharmacy Times

Since the 2018 guideline’s publication, additional non-statin therapies such as bempedoic acid, evinacumab, and inclisiran, have been approved by the FDA for the management of hypercholesterolemia.

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STAT+: One in five primary endpoints changed in late-stage trials of cancer drugs already underway, study finds

STAT

Amid increased concerns over a lack of transparency in clinical trials, a new study found that one in five primary endpoints were changed after a late-stage study had begun, and 70% of the trials examined did not include information about primary endpoint changes in articles published in medical journals. Specifically, 145 of 755 randomized controlled trials for cancer medications — or 19% — had changes to the primary endpoints when using at least one of three different methods to

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CHARM Therapeutics secures funding for oncology drug discovery research

Pharmaceutical Technology

CHARM Therapeutics has received investment from NVIDIA’s venture investment arm, NVentures, for deep learning-enabled drug discovery research. Representing a major milestone for the company, the investment will enable CHARM to do further work on the research and development of new medicines for oncology. It will also allow the company to continue to fund its growing organisation while utilising the accelerated computing platform of NVIDIA.

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UnitedHealthcare defends controversial prior authorization policy for colonoscopies

Fierce Healthcare

UnitedHealthcare defends controversial prior authorization policy for colonoscopies fdiamond Tue, 05/16/2023 - 16:43

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Challenges in Reimbursement for Pharmacy Services, DIR Fees, and the Evolving PBM Model

Pharmacy Times

Amid various obstacles, health care providers and pharmacists can initiate measures to enhance compensation for pharmacy services in managed care.

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Opinion: How I helped Pfizer think through the ethics of Viagra 25 years ago

STAT

Twenty-five years ago, 75-year-old Bob Dole — former Republican presidential candidate and U.S. senator from Kansas — went on “ Larry King Live ” and declared himself to be sexually impotent. Later that year, he became an official pitchman for Viagra, which the Food and Drug Administration approved in late March 1998 for the treatment of erectile dysfunction — though that now-common phrase hadn’t yet made its way to the lexicon.

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Could FDA recommend new antibiotic for hospital-acquired pneumonia?

European Pharmaceutical Review

A Phase III trial has found that the novel combination antibiotic sulbactam-durlobactam prevents at least as many fatalities of hospital-acquired pneumonia as colistin, the best currently approved treatment. This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus co

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