Fri.May 19, 2023

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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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How biopharma executives fight burnout

PharmaVoice

Pharma leaders share what they do to keep their teams from fizzling out.

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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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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Dual Steroid Treatment Could Be Helpful For Septic Shock

Drug Topics

Researchers found a significant decrease in mortality or discharge to hospice with the hydrocortisone-fludrocortisone combination versus hydrocortisone alone in septic shock cases.

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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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More Trending

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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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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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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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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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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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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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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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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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FDA Approves Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease

Pharmacy Times

The approval marks the first and only FDA-approved treatment for dry eye disease that directly targets tear evaporation.

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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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Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo

Fierce Pharma

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39

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FDA Approves Epcoritamab-bysp for Relapsed, Refractory Diffuse Large B-Cell Lymphoma

Pharmacy Times

Treatment with epcoritamab-bysp showed a 61% overall response rate and a 38% complete response rate in heavily pretreated patients with R/R DLBCL.

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Senators press Medicare Advantage insurers over claims denials

Fierce Healthcare

Senators press Medicare Advantage insurers over claims denials pminemyer Fri, 05/19/2023 - 14:01

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Pharmacy Focus: Psychedelic Pharmacy - Managing Potential Adverse Effects With Psychedelic Medicines

Pharmacy Times

Rick Strassman, MD, a clinical researcher, author, and expert in psychedelic medicines, sat down to discuss pharmacists' role in adverse event management.

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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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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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Bulevirtide Shows Promise for Hepatitis D, Despite No FDA Approval

Pharmacy Times

Delivery, manufacturing concerns hinder green light from US Agency, but European Medicines Agency approves treatment.

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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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Follow-up Evaluations Are Essential

Pharmacy Times

These appointments help identify medication-related problems and serve as a platform for additional education.

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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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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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Bob Narveson to step down as president and CEO of Thrifty White Pharmacy

Drug Store News

Justin Heiser, chief operating officer, will take over the reins at Thrifty White Pharmacy in January 2024.

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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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Kroger wins SEAL 2023 business sustainability award for Zero Hunger | Zero Waste Impact Plan

Drug Store News

The SEAL awards recognize leadership, transparency and commitment to sustainable business practices.

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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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STAT+: Novo Nordisk pauses ads for weight loss drug Wegovy as it struggles to meet demand

STAT

Novo Nordisk is pausing ads for its obesity drug Wegovy as it struggles to keep up with surging demand, the latest hurdle in its rollout of the weight loss drug. “To avoid stimulating further demand for this medicine, we’re pausing some key Wegovy promotional efforts,” the Danish drugmaker said in an emailed statement. “We are pausing all local television advertising and postponing planned national television advertising for Wegovy.

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Teva is eyeing $2.5bn in Austedo sales in 2027

pharmaphorum

Teva is eyeing $2.5bn in Austedo sales in 2027 Phil.

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STAT+: FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy

STAT

The Food and Drug Administration on Friday approved the first treatment for a devastating condition that causes the skin to be so fragile that even a touch can cause it to splinter, bringing another gene therapy onto the market. The therapy, known as Vyjuvek and made by Krystal Biotech, will soon be available for patients with dystrophic epidermolysis bullosa, a genetic disease that causes painful blisters and persistent wounds.

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Myeloid raises funds to support lead cell therapy programme

Pharmaceutical Technology

Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Led by Hatteras Investment Partners, the financing round has seen participation from existing investors, including 8VC, Alexandria Venture Investments and Newpath Partners, along with new investors Moore Strategic Ventures and ARCH Venture Partners.

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STAT+: FDA advisers vote against approving Intercept’s NASH drug

STAT

A panel of expert advisers to the Food and Drug Administration voted Friday against approving Intercept Pharmaceuticals’ investigational treatment for NASH, a prevalent liver disease with no available medicines. The group voted 12-2, with two abstentions, that the benefits of Intercept’s medicine did not outweigh its risks, citing serious concerns about fatal drug-related liver damage and uncertainty over whether the drug’s modest effects will ultimately improve the lives of

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