Wed.May 17, 2023

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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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FDA Approves Scoliosis Treatment For Young Patients

Drug Topics

The REFLECT Scoliosis Correction System from Globus Medical is intended to correct progressive scoliosis in pediatric patients while simultaneously maintaining stability and motion as well as allowing for future modulated growth.

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Trending Sources

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STAT+: Biotech and pharma execs wrestle with the ‘nightmare’ of developing digital biomarkers

STAT

TARRYTOWN, N.Y. — As post-lunch drowsiness settled on an auditorium full of leaders from the drug development industry, Peter Fernandes, CEO of Bellerophon Therapeutics, seized the presentation clicker and jolted them awake. “I don’t believe in dreams, I believe in nightmares,” he told the audience, drawing a laugh.  “And I love nightmares.

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Potential Racial Bias Found in TD2 Risk Prediction Models

Drug Topics

Authors offered specific recommendations for improving publishing and adoption of algorithmic processes focused on type 2 diabetes (T2D) going forward.

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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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Study: Gene Signature Panel Can Accurately Identify Most Treatment-Resistant Melanoma Cases

Pharmacy Times

The panel corresponds to proteins that are abundant in treatment-resistant melanoma cells and may predict resistance to targeted treatment.

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FDA Gives Fast Track Designations To CAR-T Lymphoma Med and Atrial Fibrillation Treatment

Drug Topics

The atrial fibrillation drug, asundexian, may provide protection from thrombotic events without a corresponding increase in bleeding risk.

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More Trending

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Investigators Publish Metric for Recommending Low-dose Aspirin Prophylaxis

Drug Topics

The atrial fibrillation drug, asundexian, may provide protection from thrombotic events without a corresponding increase in bleeding risk.

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Antidepressant Shows Promising Efficacy in Certain People for Chronic Pain Management

Pharmacy Times

Common chronic pain conditions included in the analysis were fibromyalgia, neuropathic pain, and musculoskeletal pain.

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STAT+: House panel takes first steps toward reining in hospitals with ‘site-neutral’ changes

STAT

WASHINGTON — A key House panel on Wednesday advanced several health care bills on Wednesday, including its first step toward a controversial effort to equalize Medicare payments between hospitals and physician offices. The Energy and Commerce health subcommittee passed a provision that would ensure Medicare pays the same amount to doctors who administer drugs whether they’re given in a hospital or a physician’s practice.

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6 health benefits of pickles

The Checkup by Singlecare

People have been preserving foods by the pickling process for centuries. The New York Food Museum reports that people in Mesopotamia may have been pickling foods as early as 2400 BC. And the method is just as popular today as it ever was. How many jars of pickles do you have in your fridge or pantry at this very minute? And do you have different kinds of pickled foods, too?

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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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STAT+: Could an upcoming Supreme Court case make the FDA slower?

STAT

WASHINGTON — The Food and Drug Administration could take longer to write regulations and make decisions if the U.S. Supreme Court rules against a long-standing legal doctrine giving agencies extra discretion, food and drug lawyers said Wednesday. The decades-old so-called Chevron doctrine directs judges to defer to reasonable federal agency interpretations of ambiguous or technically challenging aspects of the law.

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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+: FTC widens probe into pharmacy benefit managers to include group purchasing organizations

STAT

The Federal Trade Commission is widening its probe into pharmacy benefit managers and their impact on drug pricing by looking into a pair of group purchasing organizations that are owned by these industry middlemen, but are not well understood outside the industry. By seeking documents from Zinc Health Services and Ascent Health Services, the agency is attempting to unravel what critics complain is an opaque set of business practices and relationships.

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Chinook and Ionis partner to develop ASO therapy for kidney disease

Pharmaceutical Technology

Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy. It will use the precision medicine approach, as well as the deep expertise of Chinook Therapeutics in nephrology and knowledge of Ionis Pharmaceuticals in RNA-targeted therapeutics.

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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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Opinion: How ‘Lessons From the Covid War’ falls short

STAT

The stream of books about the government response to the pandemic that began with Michael Lewis’ “The Premonition” has just yielded its most important product to date. “ Lessons From the Covid War ” is public policy analysis at its near-best: lucid, sober, probing, at once analytical and engaging. But the book ultimately comes up a bit short, in ways that interestingly mirror the national response it chronicles and critiques.

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Consultation opens as 7.5% fee increase proposed by GPhC

Hospital Pharmacy Europe

The General Pharmaceutical Council (GPhC) has proposed raising its fees for pharmacists and pharmacy technicians by 7.5% from April 2024, and has invited feedback via an online consultation survey. The increases would affect fees for the 2024 registration assessment – for which bookings open in February 2024 – as well as registration renewal fees from April 2024.

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Opinion: Starting breast cancer screening at 40 saved my life

STAT

In 2015, the year I turned 40, the American Cancer Society updated its guidelines for breast cancer screenings. Instead of urging women to get mammograms beginning at 40, it would now recommend yearly mammograms beginning at age 45, and then every two years from age 55 on. I was greatly relieved by this news. I was a little more than a year into a wildly busy job at a news media startup.

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FDA grants priority review to Takeda’s BLA for cTTP therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP). By replacing the missing or deficient ADAMTS13 enzyme, TAK-755 offers targeted therapy for addressing an unmet medical need for thrombotic thrombocytopenic purpura patients.

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Opinion: Do chatbots have more time to be empathetic than physicians?

STAT

As an oncologist, Jennifer Lycette gets to know her patients particularly well. She’s doubtful that artificial intelligence could replace that personal connection, but new research based on, of all things, Reddit Q&As, says otherwise. The study, which Lycette wrote about in her essay, “ Why a chatbot might seem more empathetic than a human physician, ” found that chatbot-generated notes were, in some ways, better than notes from actual humans.

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FTC expands probe into pharmacy benefit managers to GPOs

Fierce Healthcare

FTC expands probe into pharmacy benefit managers to GPOs pminemyer Wed, 05/17/2023 - 16:36

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Digitization Can Optimize the Entire Timeline of a Clinical Trial to Improve Endpoints

Pharmacy Times

Experts have seen the value of technology in the clinical trial space because it helps to remove natural bias that can leads to inaccuracies in data collection.

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Opinion: New draft recommendations for mammograms take a one-size-fits-all approach

STAT

On May 9, the United States Preventive Services Task Force (USPSTF) released updated draft recommendations for breast cancer screening. In contrast to their prior recommendations that most women start screening at 50, the USPSTF — a major national body making preventive care recommendations — now recommends screening mammography every two years for all women ages 40 to 74 years.

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503B: What Should Pharmacists Know for 2023?

Pharmacy Times

When considering outsourcing, pharmacies should use multistakeholder team to weigh pros and cons.

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Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

Fierce Pharma

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41

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Novel Study Evaluates Implementation of Long-Acting Injectable PReP In Sexual, Gender Minorities

Pharmacy Times

Preexposure prophylaxis use for HIV continues to be lower than desired in some populations.

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STAT+: PTC Therapeutics’s PKU drug succeeds in trial, but bigger hurdles for company are ahead

STAT

Biotech firm PTC Therapeutics said Wednesday that its drug for phenylketonuria, or PKU, met its key goal in a Phase 3 study. In PKU, patients’ bodies are unable to break down the amino acid phenylalanine, resulting in intellectual disability, memory problems, and other neurological issues. In the 156-volunteer trial, the drug, sepiapterin, reduced levels of phenylalanine by 63% compared to a placebo, PTC said in a press release.

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WellSpan Health partners with Emerus to build three 'neighborhood hospitals' in southern Pennsylvania

Fierce Healthcare

WellSpan Health partners with Emerus to build three 'neighborhood hospitals' in southern Pennsylvania dmuoio Wed, 05/17/2023 - 13:52

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STAT+: CVS Health to close clinical trial unit two years after launch

STAT

WOONSOCKET, R.I. — Two years after its launch, CVS Health is planning to close down its clinical trials unit by the end of 2024, to refocus on core operations. Since the pandemic began, the drug store chain  has doubled down on its efforts to build a health care business  that would move it further into the home health and primary care spaces.

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'Podnosis': How tech can help diagnose neurodevelopmental disabilities and how insurtechs can be profitable

Fierce Healthcare

'Podnosis': How tech can help diagnose neurodevelopmental disabilities and how insurtechs can be profitable tcarey Wed, 05/17/2023 - 09:26

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STAT+: Pharmalittle: FTC suit over Amgen spotlights ‘bundling’ deals with insurers; FDA staff says Pfizer RSV vaccine is effective

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? Consider the alternatives, after all. And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today boasts the aroma of blueberries — and get started.

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VA renegotiates $10B Oracle Cerner EHR contract with stronger performance metrics, bigger penalties

Fierce Healthcare

VA renegotiates $10B Oracle Cerner EHR contract with stronger performance metrics, bigger penalties hlandi Wed, 05/17/2023 - 13:22

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Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Fierce Pharma

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

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The Digital Health Continuum – Connecting Clinical Trials to Care Delivery

Fierce Healthcare

The Digital Health Continuum – Connecting Clinical Trials to Care Delivery mteefey Wed, 05/17/2023 - 16:26

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Intratumoural viral delivery improves glioblastoma survival

European Pharmaceutical Review

An engineered oncolytic virus (DNX-2401) targeting glioblastoma (GBM) cells combined with subsequent immunotherapy using intratumoural delivery , gave a 52.7 percent 12-month overall survival (OS) rate for patients with recurrent GBM. According to the Phase I/II trial results published in Nature Medicine , this is higher than the prespecified efficacy threshold of 20 percent.