Tue.Sep 03, 2024

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The Unyielding Grip of Fentanyl on America's Streets: A Pharmacist's Perspective

Drug Topics

Independent pharmacists, health care providers, community leaders, and law enforcement must all work together to address the fentanyl epidemic.

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Doctors use problematic race-based algorithms to guide care every day. Why are they so hard to change?

STAT

Pediatrician Alexandra Epee-Bounya had had enough. In her 20 years caring for children in Boston, she had seen hundreds of kids with suspected urinary tract infections. Each time, she’d turn to a calculator, used by all Boston Children’s Hospital clinicians, to judge the youngest childrens’ risk. Did the infant have a high fever?

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FDA Approves Updated Novavax COVID-19 Vaccine

Drug Topics

The protein-based vaccine includes a monovalent component corresponding to the Omicron variant JN.1 strain.

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Opinion: Letting funding for the All of Us research program lapse will cost the U.S. far more than it saves

STAT

I was in high school when I first encountered the ruthlessness of the number one killer in the U.S. A close friend of mine, then only 16 years old, witnessed his father having a heart attack while checking the mail. Despite desperate attempts at CPR on the driveway, he wasn’t able to save his dad, a seemingly healthy man in his early 40s. That event put me on a path to become a cardiologist.

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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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FDA Authorizes New Drug Application For Trial to Evaluate Treatment for Long COVID

Pharmacy Times

Bezisterim, an anti-inflammatory insulin sensitizer, will be authorized to proceed to a phase 2 clinical trial.

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STAT+: Diagnosed with cancer, a pharmaceutical executive became a patient advocate and changed drug development. It took decades

STAT

Kathy Giusti was diagnosed with multiple myeloma in 1996, when she was a 37-year-old executive at the drug company G.D. Searle. She was told she had three years to live. Twenty-eight years later, Giusti, 65, is thriving. One reason is the patient advocacy group she founded in 1998: the Multiple Myeloma Research Foundation. The group has raised more than $600 million for research, launched nearly 100 clinical trials, and helped bring more than 15 new drugs to market.

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More Trending

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How race became ubiquitous in medical decision-making tools

STAT

It was created with the best intentions: a government policy asking researchers to collect racial data to help address health disparities. But it may have had an unintended opposite effect, paving the way for the problematic use of race in an array of medical decision-making tools. Starting in the 1990s, the National Institutes of Health began requiring the collection and reporting of racial data in its funded research.

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Insurance Status, Survival Outcomes Linked in Patients With Diffuse Large B-Cell Lymphoma

Pharmacy Times

Patients with DLBCL on Medicaid had worse survival outcomes than those on commercial insurance, but there were no statistically significant differences in survival between races.

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STAT+: Recursion presents mixed data on lead AI-derived drug candidate for potentially fatal brain condition

STAT

Recursion Pharmaceuticals announced results of a clinical trial for its lead drug candidate Tuesday that, while a success on paper, likely won’t satisfy many investors closely watching the AI drug developer.  The Salt Lake City company’s treatment is for cerebral cavernous malformation , or CCM, a potentially life-threatening condition that causes vessels in the brain to become enlarged and irregular, sometimes causing blood to leak into the brain or spinal cord.

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In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

Fierce Pharma

Late last year, Novo Nordisk responded to a growing shortage of popular Ozempic with a plan to cut down on production of its older diabetes med Victoza to make room for more Ozempic. | The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.

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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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STAT+: Vaxcyte shares boom as one of biotech’s big David vs. Goliath stories heats up

STAT

With new vaccine data released Tuesday, Vaxcyte, a San Carlos, Calif.-based firm, emerged as one of biotechnology’s hottest David-vs.-Goliath stories as the company seeks to challenge one of Pfizer’s biggest franchises: the Prevnar vaccine against pneumococcal disease. Shares in the company rocketed up 36% on the new data — released via press release — bringing the stock’s gain over the past 12 months to 115%.

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Out-of-pocket spending on prescriptions grew even after accounting for rebates: study

Fierce Healthcare

There's no shortage of attention on rising pharmaceutical costs, but policymakers need to have the full picture of trends in this space to work off of, according to a new study. | There's no shortage of attention on rising pharmaceutical costs, but policymakers need to have the full picture of trends in this space to work off of, according to a new study.

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STAT+: Drug aimed at strengthening neurons to treat Alzheimer’s fails in trial

STAT

A dark horse effort to treat Alzheimer’s disease, already marred by a data manipulation scandal, fell short in a randomized trial reported Tuesday afternoon. Athira Pharma said that Alzheimer’s patients who received its experimental injection fosgonimeton did not decline at a significantly slower rate than patients who received a placebo injection.

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Pharmacy Students Discuss Learning Through Social Media Platforms

Pharmacy Times

Pharmacy students discuss how they use social media platforms like TikTok, Instagram, and YouTube to reinforce their classroom learning.

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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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Explore the clinical tools that use race to steer care

STAT

Every day, physicians use clinical algorithms to make decisions about the patients in their exam rooms. To help weigh a patient’s surgical risk or likelihood of disease, they factor in attributes such as blood pressure, age, weight, surgical history — and in some cases, a patient’s race. Like many clinical researchers, bioinformatician Shyam Visweswaran started learning about those race-based tools in 2020, when a catalyzing New England Journal of Medicine paper laid out 13

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Study Finds Race Impacts Cancer Stage at Diagnosis and Patient’s Overall Survival

Pharmacy Times

The risk of late-stage diagnosis was higher for Asian, Black, and Native Hawaiian or Other Pacific Islander adolescent and young adult patients with cancer.

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Why clinicians are reconsidering race-based algorithms

STAT

Algorithms are ubiquitous in medicine. They can take the form of a flowchart, a simple equation, or a complicated AI model, and are used to help clinicians diagnose diseases, predict the chances of survival, and determine if a patient is eligible for certain treatments. Many of these algorithms take a person’s race into account. For example, if the person is Black, a clinician may add or subtract a point from the patient’s score, which can affect their treatment.

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Startup Harrison.ai launches radiology-specific language model as a building block for healthcare AI

Fierce Healthcare

Australia-based startup Harrison.ai spent the past four years building out AI-powered medical diagnostic software and services. | Australian health tech company Harrison.ai has unveiled what it considers to be a "groundbreaking" radiology-specific vision language model designed to excel at radiology tasks. It's part of the startup's broader goal to use AI automation to scale the global capacity of healthcare.

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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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STAT+: Greece’s antitrust regulator probes Novartis over practices tied to a pricey eye drug

STAT

Greece’s antitrust regulator is investigating allegations that, over a nine-year period, Novartis paid doctors and institutions to prescribe a pricey treatment for a serious eye disease and also disparaged rival medicines. In a brief statement, the Hellenic Competition Commission disclosed it is probing evidence the company paid physicians for travel to conferences and participation in studies in order to boost sales of Lucentis, which is used to treat age-related macular degeneration, a

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Weight-Adjusted Waist Index Can Have Prognostic Value in Patients With Asthma

Pharmacy Times

A recent study found that a weight-adjusted waist index was an independent predictor of all-cause-, cardiovascular-, cancer-, and respiratory-related mortality in patients with asthma.

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The biotech news you need to read this morning

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning! Today, we discuss the woman who spearheaded progress in multiple myeloma for decades, see mixed but promising results from Sanofi’s multiple sclerosis drug, and hear why All of Us should not be defunded.

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Illumina avoids hefty EU fine over Grail merger

pharmaphorum

EU had no grounds to probe Illumina's takeover of Grail, says ECJ, but while spinoff has already taken place Illumina can now avoid a €432m fine

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STAT+: Dana-Farber CEO Laurie Glimcher to step down, saying ‘we must look to the next generation’

STAT

Laurie H. Glimcher, chief executive of Dana-Farber Cancer Institute, said she would step down next month, ending an eight-year run capped by her  surprise split  with Dana-Farber’s longtime partner, Brigham and Women’s Hospital, and decision to build a cancer center with Beth Israel Deaconess Medical Center. Benjamin L. Ebert, chair of Dana-Farber’s medical oncology department and a prize-winning researcher, will take over from Glimcher on Oct. 1, the Boston instit

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Scilex's Semnur Pharmaceuticals to go public through $2.5B SPAC merger as it advances sciatica prospect

Fierce Pharma

Semnur Pharmaceuticals, which is working on a non-opioid prospect for sciatica, has agreed to merge with special purpose acquisition company Denali Capital Acquisition Corp. | Semnur Pharmaceuticals is following in its parent company Scilex's footsteps with a special purpose acquisition company (SPAC) merger.

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STAT+: European court sides with Illumina, saying regulators overstepped in scrutiny of Grail deal

STAT

LONDON — Europe’s top court on Tuesday ruled that regulators overstepped in challenging the DNA sequencing behemoth Illumina’s acquisition of Grail, finding that the European Commission did not have jurisdiction over the deal.  The decision won’t have a major impact on the Illumina-Grail relationship, with Illumina having divested the cancer screening company over the summer.

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FDA Authorizes IND For Phase 2 Clinical Trial Evaluating Treatment for Post–COVID-19 Condition

Drug Topics

Bezisterim acts on inflammatory signaling pathways and may be a viable treatment option for post–COVID-19 condition, or long COVID.

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Unpacking the High Cost of GLP-1 Drugs

Pharmaceutical Commerce

How can industry stakeholders ensure the quality and supply chain security of existing product?

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Data builds behind Valneva, Pfizer's Lyme disease vaccine

pharmaphorum

New data for Valneva and Pfizer's Lyme disease vaccine bolsters the case for the shot as the results of a phase 3 programme are awaited.

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UAE MoHAP and Novo Nordisk partner for obesity management

Pharmaceutical Technology

The UAE has partnered with Novo Nordisk Pharma Gulf to develop a national scientific guide for obesity management and weight control.

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Dr. Reddy's banned from China's drug procurement program after inspectors turn up manufacturing problems

Fierce Pharma

Dr. Reddy’s has been cut off from China’s bulk-buy drug procurement program after an inspection turned up “serious defects” in the company’s manufacturing operations. | Following a remote inspection of a Dr. Reddy’s formulations production plant, China’s National Medical Products Administration has suspended the import, sale and use of the Indian drugmaker’s atomoxetine hydrochloride capsules for ADHD.

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HDA 2024 Traceability Seminar: Legal Advice for DSCSA Compliance Teams

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

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Metagenomics revolution: Empress Therapeutics on drug discovery breakthroughs

Outsourcing Pharma

Dr Dawn Thompson has over 20 years of experience in building technology platforms that leverage genomics at scale to produce novel products.

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Pharma Pulse 9/3/24: CrowdStrike VP to Testify on IT Outage, Embracing FSPs & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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