Mon.May 13, 2024

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FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years

Drug Topics

Altuviiio was first granted approval by the FDA in February 2023.

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Hormone Therapy, Vitamin Supplementation in Postmenopausal Women Did Not Decrease Risk of Cancer, Chronic Disease

Pharmacy Times

Study investigators also found that dietary modifications were not associated in improving risks of certain chronic diseases and cancers.

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In Frankfurt, Pharmacy Takes a Different Approach

Drug Topics

In Germany, data live in the cloud, patients can fill prescriptions at any pharmacy, and the wholesale price of semaglutide (Ozempic) is a fraction of the cost.

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CDC launching wastewater dashboard to track bird flu virus spread

STAT

Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread , prompting federal public health officials to look to wastewater to help fill in the gaps. On Monday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the

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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 Grants Fast Track Designation for SNB-101 to Treat Small Cell Lung Cancer

Pharmacy Times

SNB-101 is the first nanoparticle anticancer drug that was developed exceedingly insoluble SN-38 into polymer nanoparticles.

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Illicit Fentanyl Seizures Increased Nearly 2000% Within 7-Year Period In US

Drug Topics

Study results suggest a nationwide increase in the supply and availability of illicitly manufactured fentanyl, with pills becoming more dominant across the ever-shifting US fentanyl market.

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More Trending

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Opinion: A dose of reality on adult vaccinations

STAT

The number of children who received their routine vaccinations declined during the pandemic, so public health officials have been focusing on getting kids back up to date. They should also be paying attention to adults as a new, first-of-its-kind report quantifying the economic impact of adult immunizations makes clear. Researchers at the nonprofit Office of Health Economics , based in London, analyzed four adult vaccine programs — for the flu, pneumonia, respiratory syncytial virus (RSV)

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Positive Data of Coartem for Malaria in Infants Weighing Less Than 5 kg

Pharmacy Times

The data were previously presented at the Multilateral Initiative on Malaria 8th Pan-African Malaria Conference and have been submitted for regulatory review.

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After decades fighting Big Tobacco, Cliff Douglas now leads a foundation funded by his former adversaries

STAT

“Does it trouble you to answer that question?” one of New York’s highest paid attorneys asked Cliff Douglas, then a 36-year-old activist who had found himself at the center of a $10 billion libel lawsuit brought by the cigarette giant Philip Morris. Philip Morris’ lawyer Herbert Wachtell demanded to know: Were cigarette companies intentionally killing people?

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RAND: Hospitals charged insurers 254% more than Medicare rates in 2022

Fierce Healthcare

The gap between insurance plans and Medicare's payments to hospitals for inpatient and outpatient services widened over the course of just a couple of years, a new study from RAND Corporation | A new report from RAND Corporation highlighted just how much more employers and private insurers are paying hospitals for inpatient and outpatient services.

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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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Opinion: Congress: Close Medicare’s dangerous gaps in coverage for addiction treatment

STAT

While many people immediately picture young adults when thinking about the current addiction and overdose epidemic, this crisis is affecting all generations. In fact, more than 7 million older Americans struggle with substance use disorders. Opioid use disorder, in particular, has skyrocketed among Medicare beneficiaries , with opioid overdose death rates rising higher among people 65 and older than in any other age group.

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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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STAT+: FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents

STAT

When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA. For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency registry.

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As Bristol Myers reveals trial failure, AstraZeneca's Imfinzi stays king in stage 3 lung cancer

Fierce Pharma

Another attempt at improving upon AstraZeneca’s Imfinzi in stage 3, unresectable non-small cell lung cancer (NSCLC) has gone up in flames. | Following AstraZeneca's setback in attempting to improve upon Imfinzi's efficacy in unresectable stage 3 lung cancer, a Bristol Myers Squibb endeavor has gone up in flames, as well. Now, market watchers are turning their attention to upcoming readouts from Merck & Co. and Roche.

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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+: Late-stage results set up Cytokinetics heart drug to compete with Bristol

STAT

Late-stage results of Cytokinetics’ drug for a rare heart disease suggest it can compete with a similar treatment sold by Bristol Myers Squibb on efficacy and safety, and can also be dosed more conveniently, potentially making it a more attractive option for doctors if approved. The 24-week Phase 3 trial tested the drug, a daily pill called aficamten, in patients with obstructive hypertrophic cardiomyopathy, or oHCM, a disease in which the heart has more difficulty pumping blood and patie

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Transforming clinical trials with open-source tech

pharmaphorum

Think open-source is just for software? Think again. Learn how clinical researchers are embracing open data and tools to overhaul the drug development process.

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STAT+: The stories that shaped our understanding of the health care system

STAT

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday. We did something a little different for this issue: We wanted to share some of the stories that explain the machinations of the U.S. health care system — stories that really influenced how we think about and report on this industry.

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Shionogi's antiviral comes up short in global COVID-19 trial

Fierce Pharma

While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global sta | While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage.

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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+: Can AI build custom ‘n-of-1’ drugs faster? Maybe not yet, new case study suggests

STAT

Two years ago, Yiwei Shi was searching desperately for someone to build a drug for her newborn son, Leo. Leo was born with a very small head, a symptom of many severe diseases. After a seizure at two months, doctors sequenced his genome and found a single misspelling in a gene called TNPO2.  Little was known about the gene, except that it was involved in neurodevelopment.

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The Role of Complementary and Integrative Health Competency in Pharmacy

Pharmacy Times

Complementary and integrative health has been divided into 5 subcategories, including alternative whole medical systems and mind-body interventions.

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Genetic variant common among West African descendants contributes to large cardiovascular disease burden

STAT

Among cardiologists, it’s known that transthyretin cardiac amyloidosis, a type of heart disease, is caused by the misfolding of a protein called transthyretin, which builds up in the walls of the heart, causing the muscle to get thicker and stiffer. One reason this can happen is because of a genetic mutation caused by the gene variant V142I, which is commonly found in people of West African descent.

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In new letter to Defense Department, WuXi AppTec refutes claim of secret data transfer

Fierce Pharma

Of all the allegations thrown at WuXi AppTec during an ongoing U.S. | Facing potential sanctions from the Department of Defense and a recent allegation that it had transferred a U.S. client's data to Beijing without consent, WuXi AppTec is again rebutting claims of its ties with Chinese authorities.

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STAT+: Sandoz disavows U.K. trade group over dispute about promoting a biosimilar for multiple sclerosis

STAT

In an unusual move, Sandoz is no longer cooperating with a U.K. industry trade group following a dispute over allegations that the company inappropriately marketed a biosimilar medicine. At issue was an anonymous complaint filed in May 2023 by a physician who contended that Sandoz unfairly attempted to promote a biosimilar version of Tysabri for treating multiple sclerosis as an affordable option.

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Johnson & Johnson looks to offload remaining Kenvue stake in $3.75B deal

Fierce Pharma

After Johnson & Johnson's consumer healthcare spinoff last year—and its subsequent reduction in holdings in the new company—the healthcare conglomerate is once again cutting its stake in&n | Johnson & Johnson is again cutting its holdings in Kenvue. This time, it's pursuing a "debt-for-equity" offering that looks to be worth about $3.75 billion.

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Talkspace expands online mental health therapy to millions of Medicare members

Fierce Healthcare

Online therapy provider Talkspace is making a big push into the Medicare market, rolling out to approximately 13 million members in 11 states. | Talkspace plans to expand to all 33 million traditional Medicare members, coupled with several Medicare Advantage plans, across all 50 states by the end of the year.

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Biosimilars Play Growing Role in Psoriasis Treatment Strategies

Pharmacy Times

These options are typically more cost-effective, enhancing patient accessibility

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Is digital therapeutics innovation enough for a sustainable future?

pharmaphorum

Digital therapeutics are transforming healthcare, but are they enough for a sustainable future? This post discusses whether innovation in digital therapeutics that empower patients is sufficient for long-term sustainability.

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FDA Approves Updated Label for Altuviiio to include Full Data on Pediatric Patients With Hemophilia A

Pharmacy Times

Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.

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Who delays NICE technology appraisals anyway?

pharmaphorum

NICE technology appraisals for cancer drugs are often delayed - but who's really to blame? This post investigates how the DHSC contributes to hold-ups in access to innovative cancer treatments.

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American Thoracic Society Addresses Issues in Asthma Awareness

Drug Topics

During World Asthma Day on May 7, advocacy groups for asthma awareness addressed the need for better worldwide education.

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MSD has another TIGIT programme setback

pharmaphorum

A phase 3 trial of MSD’s TIGIT antibody has been abandoned after a high rate of discontinuations rendered the study futile

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An Evolving Understanding of Local Allergic Rhinitis

Drug Topics

Researchers aimed to better understand the intricacies of local allergic rhinitis and how it differs from allergic rhinitis.

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Rise of drug-resistant superbugs could make Covid pandemic look ‘minor’, expert warns

The Guardian - Pharmaceutical Industry

Common infections will kill millions if drug resistance through misuse of antibiotics is not curbed, says England’s ex-chief medical officer What is antimicrobial resistance and how big a problem is it? The Covid-19 pandemic will “look minor” compared with what humanity faces from the growing number of superbugs resistant to current drugs, Prof Dame Sally Davies, England’s former chief medical officer, has warned.

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