Sat.Feb 01, 2025 - Fri.Feb 07, 2025

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Heart Disease Remains Leading Cause of Death in US

Drug Topics

The prevalence of high blood pressure is highest in Mississippi at 40.2% compared with the lowest in Colorado at 24.6%.

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STAT+: FDA approves first xenotransplantation clinical trial, as United Therapeutics forges ahead

STAT

United Therapeutics said Monday that the Food and Drug Administration has cleared it to begin the first clinical trial testing whether organs from gene-edited pigs could provide a viable option for patients in dire need of an organ transplant. Over the last three years, United and a rival company, eGenesis, have transplanted genetically modified pig hearts or kidneys into several patients, but those procedures were done through compassionate use waivers from the FDA that allow doctors to treat i

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FDA sends warning letter to KVK-Tech manufacturing facility

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. The FDA issued the warning letter to KVK-Tech in February 2020, advising that due to these cGMP breaches, the companys products are adulterated according to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Drugmakers prep for bird flu outbreak, despite continued low risk

PharmaVoice

While the virus hasn’t made a sustained leap into humans, vaccines and treatments are coming through the pipes if it does.

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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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COVID-19 Had Worst Disease Outcomes Among Respiratory Viruses

Drug Topics

In their exploration of 2 separate respiratory virus seasons, researchers examined the severity of illness for SARS-CoV-2, influenza, and respiratory syncytial virus.

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Q&A: How gluten-free processed foods put people with celiac disease at risk

STAT

People with celiac disease face a food paradox. Gluten-free bagels, brownie mixes, and frozen burritos beckon from grocery store shelves. Yet despite this abundance, they can’t trust that these foods are actually safe to eat. The story of how the food industry went gaga for gluten-free products, putting the health of people with celiac at risk in the process, takes center stage in Emily Abel’s new book, “Gluten Free for Life: Celiac Disease, Medical Recognition, and the Food

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Tariffs raise concern among generic drugmakers, and advocacy groups are seeking exemptions

PharmaVoice

While the 10% tariff on Chinese goods won’t have too much impact on branded drugs, generics are struggling to pivot.

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Biofeedback Shows Promising Results in Treating Chronic Pain

Drug Topics

In a systematic review, researchers explored how biofeedback impacted rehabilitation in patients experiencing chronic pain disorders.

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STAT+: DeepSeek signals China’s rising influence in AI — and AI drug development

STAT

Is China setting the global standard for AI-driven drug development? DeepSeek, a relatively unknown AI firm based in Hangzhou, China, shocked the industry last week with claims that its technology could rival the abilities of technologies developed by leading U.S. AI companies — and do so far more economically. The claims ignited debates not just about the implications for AI companies like OpenAI but for the U.S. drug industry, which is increasingly turning to AI in hopes of develop

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Study Finds COVID-19 Infection Associated With More Severe Disease Compared With Flu, RSV

Pharmacy Times

Investigators noted that the differences between the 3 respiratory infections were not as pronounced during the 2023-2024 season.

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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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Farxiga vs. Jardiance: Key differences, uses, and side effects

The Checkup by Singlecare

Farxiga and Jardiance are two brand-name oral medications approved by the U.S. Food and Drug Administration (FDA) to manage Type 2 diabetes mellitus. Both are sodium-glucose cotransporter 2 (SGLT2) inhibitors. Farxiga, manufactured by AstraZeneca, contains the active drug dapagliflozin, and Jardiance, manufactured by Boehringer Ingelheim Pharmaceuticals, contains the active drug empagliflozin.

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Dead Birds on Lake Michigan Shore Raise Bird Flu Concerns in Chicago

Drug Topics

Experts believe a bird flu outbreak is responsible for hundreds of dead birds washing ashore on the beaches of Chicago.

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The first shot taken at Medicaid, and Optum’s wellness visit ad

STAT

This is the online version of STAT’s email newsletter Health Care Inc, delivered to your inbox every Monday.  Sign up here.  The most sustainable, and personally meaningful, way to fund journalism is through viewers like you. STAT is running a 50% discount right now. If it makes sense for you financially, think about it. This newsletter and my inbox are always here for you, too: bob.herman@statnews.com.

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Video: GLP-1 Medications Revolutionize Obesity and Diabetes Care, With Exciting Advances on Horizon

Pharmacy Times

Donna Ryan discusses the landscape of GLP-1 medications and the lineup of indications that the drug class has received indications for in recent years.

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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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Fierce Healthcare - Untitled Article

Fierce Healthcare

Government unions and cybersecurity experts are disturbed by Elon Musk's newfound access to personal information and the country's payment infrastructure, which coordinates funds for government health programs like Medicare and Medicaid.

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Amazon Pharmacy’s Subscription Service Associated With Improved Medication Adherence, Reduced Costs

Drug Topics

Approximately 29% of patients were also more likely to refill their medication, leading investigators to consider an association between medication adherence.

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Opinion: HPV self-collection tests must be approved for use at home

STAT

Women’s health champions like us cheered in January when the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation for cervical cancer screening for high-risk genotypes of human papillomavirus (HPV), including the use of self-collection tests. The move follows the Food and Drug Administration’s approval of self-collection tests last summer.

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Flu, RSV, COVID-19, and More: Updates on the 2025 Respiratory Virus Landscape

Pharmacy Times

Rising seasonal viruses and emerging concerns emphasize the need for public awareness and prevention.

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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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Pharmacy Team Development: Top Blogs of 2024

DiversifyRx

Your pharmacy team will either be your greatest strength or your weakest link. Pharmacy Team development is a critical pillar for independent pharmacy owners aiming to enhance operational efficiency, boost employee satisfaction, and improve patient care. Investing in your team’s growth fosters a positive work environment and directly contributes to your pharmacy’s success.

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APhA Platform Aims to Tackle Pharmacy Workforce Shortage

Drug Topics

The American Pharmacists Association announced the launch of its transformative HealthShifts platform in collaboration with the California Pharmacists Association and powered by Locumate.

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Opinion: A bold experiment: Let’s bribe West Virginia to reduce its obesity rate

STAT

To many, Robert F. Kennedy Jr. appears to advocate positions that are contrary to scientific orthodoxy, but there’s one area where he and his critics largely agree: Healthier eating leads to a healthier population. Obesity, for instance, is a major and costly health problem that is only getting worse. Excess body fat and obesity are linked to type 2 diabetes, coronary artery disease, and hypertension, among other ailments.

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American Heart Association Launches Initiative to Increase Education on Heart Failure

Pharmacy Times

The initiative will provide information about care models for specialists and clinical teams to improve patient outcomes in heart failure.

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Fierce Healthcare - Untitled Article

Fierce Healthcare

The storm decimated half a dozen states, killing hundreds and forcing local health systems to contend with the fallout. Some hospitals were well prepared. Others were destroyed. Everyone was doing what they could to figure out contingencies on the fly. This, experts warn, will not be the last time.

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Digital Education Games Could Help Improve Diabetes Management in Children

Drug Topics

Children with type 1 diabetes who watched educational videos and played games had improved glycemic control and quality of life.

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Here is how we know that vaccines do not cause autism

STAT

Vaccines do not cause autism. You’ve almost certainly read that before — probably hundreds of times. But many people do not believe it, perhaps because too often it is repeated without a real explanation of how we know that. So here is an attempt to offer that explanation.

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FDA Grants Fast Track Designation to ADI-001 for Treatment of Refractory Systemic Lupus Erythematosus

Pharmacy Times

The designation builds on previous regulatory action for ADI-001 and allows for expedited development of the treatment for systemic lupus erythematosus.

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Fierce Healthcare - Untitled Article

Fierce Healthcare

Managers across the health agencies were tasked with categorizing their probationary workers to determine those who were not mission critical, according to two new media reports citing internal sources.

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FDA Grants ADI-001 Fast Track Designation as Treatment of Refractory Systemic Lupus Erythematosus

Drug Topics

ADI-001 is an investigation allogeneic gamma delta chimeric antigen receptor T cell therapy that targets CD20 for the treatment of a variety of autoimmune diseases.

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Bristol Myers gives first peek at closely watched launch of schizophrenia drug

PharmaVoice

Cobenfy, the main asset acquired through Bristol Myers’ $14 billion purchase of Karuna, had $10 million in sales in the fourth quarter and around 1,000 prescriptions weekly by late January.

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Study Finds High Prevalence of Vitamin and Mineral Deficiency in Type 2 Diabetes

Pharmacy Times

Investigators found that 60% of individuals with type 2 diabetes are vitamin D deficient.

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Pharmacy Law and Licensing Highlights 2025

The FDA Law Blog

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements.

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Subcutaneous Amycretin Shows Weight Loss of 9.7% for 20 Weeks

Drug Topics

In a phase 1b/2a clinical trial, investigators evaluated the once weekly subcutaneous drug for safety, tolerability, pharmacokinetics, and proof-of-concept.

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With uncertainty roiling Big Pharma, execs are placing lower-risk bets

PharmaVoice

The market has been no less demanding for pharma giants as 2025 begins, but last year’s strategies are paying off.

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