In Frankfurt, Pharmacy Takes a Different Approach
Drug Topics
MAY 13, 2024
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.
Mon.May 13, 2024
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CDC launching wastewater dashboard to track bird flu virus spread
STAT
MAY 13, 2024
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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Illicit Fentanyl Seizures Increased Nearly 2000% Within 7-Year Period In US
Drug Topics
MAY 13, 2024
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.
Positive Data of Coartem for Malaria in Infants Weighing Less Than 5 kg
Pharmacy Times
MAY 13, 2024
The data were previously presented at the Multilateral Initiative on Malaria 8th Pan-African Malaria Conference and have been submitted for regulatory review.
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.
FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years
Drug Topics
MAY 13, 2024
Altuviiio was first granted approval by the FDA in February 2023.
Dietary Resistant Starch, RAS Inhibitor Demonstrate Protective Effect on Kidney for Type 2 Diabetes
Pharmacy Times
MAY 13, 2024
In diabetic rats, investigators found a decrease in urine biomarkers and expression of proteins that play a part in renin-angiotensin system (RAS).
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Hormone Therapy, Vitamin Supplementation in Postmenopausal Women Did Not Decrease Risk of Cancer, Chronic Disease
Pharmacy Times
MAY 13, 2024
Study investigators also found that dietary modifications were not associated in improving risks of certain chronic diseases and cancers.
RAND: Hospitals charged insurers 254% more than Medicare rates in 2022
Fierce Healthcare
MAY 13, 2024
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.
After decades fighting Big Tobacco, Cliff Douglas now leads a foundation funded by his former adversaries
STAT
MAY 13, 2024
“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?
Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot
pharmaphorum
MAY 13, 2024
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.
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.
Opinion: Congress: Close Medicare’s dangerous gaps in coverage for addiction treatment
STAT
MAY 13, 2024
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.
FDA Grants Fast Track Designation for SNB-101 to Treat Small Cell Lung Cancer
Pharmacy Times
MAY 13, 2024
SNB-101 is the first nanoparticle anticancer drug that was developed exceedingly insoluble SN-38 into polymer nanoparticles.
STAT+: FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents
STAT
MAY 13, 2024
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.
Transforming clinical trials with open-source tech
pharmaphorum
MAY 13, 2024
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.
5 Reasons to Upgrade Your Pharmacy Management Software
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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.
Talkspace expands online mental health therapy to millions of Medicare members
Fierce Healthcare
MAY 13, 2024
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.
The Role of Complementary and Integrative Health Competency in Pharmacy
Pharmacy Times
MAY 13, 2024
Complementary and integrative health has been divided into 5 subcategories, including alternative whole medical systems and mind-body interventions.
Genetic variant common among West African descendants contributes to large cardiovascular disease burden
STAT
MAY 13, 2024
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.
FDA Approves Updated Label for Altuviiio to include Full Data on Pediatric Patients With Hemophilia A
Pharmacy Times
MAY 13, 2024
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.
STAT+: Late-stage results set up Cytokinetics heart drug to compete with Bristol
STAT
MAY 13, 2024
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
Is digital therapeutics innovation enough for a sustainable future?
pharmaphorum
MAY 13, 2024
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.
STAT+: The stories that shaped our understanding of the health care system
STAT
MAY 13, 2024
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.
Who delays NICE technology appraisals anyway?
pharmaphorum
MAY 13, 2024
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.
An Evolving Understanding of Local Allergic Rhinitis
Drug Topics
MAY 13, 2024
Researchers aimed to better understand the intricacies of local allergic rhinitis and how it differs from allergic rhinitis.
When Worlds Collide: The Theory of Real-World Evidence Meets Reality
The FDA Law Blog
MAY 13, 2024
By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.
American Thoracic Society Addresses Issues in Asthma Awareness
Drug Topics
MAY 13, 2024
During World Asthma Day on May 7, advocacy groups for asthma awareness addressed the need for better worldwide education.
Evernorth: How employers can take the lead on addressing youth mental health
Fierce Healthcare
MAY 13, 2024
Mental health concerns among youth continue to rise, and employers can play a significant role in mitigating these challenges, according to a new study from Cigna's Evernorth division. | Mental health concerns among youth continue to rise, and employers can play a significant role in mitigating these challenges, according to a new study from Cigna's Evernorth division.
Shionogi's antiviral comes up short in global COVID-19 trial
Fierce Pharma
MAY 13, 2024
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.
Rise of drug-resistant superbugs could make Covid pandemic look ‘minor’, expert warns
The Guardian - Pharmaceutical Industry
MAY 13, 2024
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.
As Bristol Myers reveals trial failure, AstraZeneca's Imfinzi stays king in stage 3 lung cancer
Fierce Pharma
MAY 13, 2024
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.
Too Much of a Good Thing? Unpacking the Rise of Polypharmacy in Seniors
PharmD Live
MAY 13, 2024
Introduction In an era marked by a rapidly aging population, the challenge of managing polypharmacy—the use of multiple medications by a patient, particularly among those over 65—has emerged as a pivotal issue for healthcare providers. For small independent clinics and larger health systems, addressing polypharmacy effectively is critical to optimizing patient outcomes, reducing risks, and ensuring financial sustainability.
Sanofi to invest €1bn in France to lift ‘health sovereignty’
pharmaphorum
MAY 13, 2024
Sanofi will invest more than €1 billion ($1.08 billion) in new bioproduction capacity at three manufacturing sites in France as part of a €3.5 billion programme in the country. The latest tranche of investment – at Vitry-sur-Seine in Val de Marne, Le Trait in Seine-Maritime, and Lyon Gerland in the Rhône region – is part of a drive to reduce the reliance of France and the wider EU on manufacturing capacity in other parts of the world and boost supply chain security and resiliency.
Johnson & Johnson looks to offload remaining Kenvue stake in $3.75B deal
Fierce Pharma
MAY 13, 2024
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.
Wearable device ‘may prevent heart failure hospitalisation’
pharmaphorum
MAY 13, 2024
Monitoring of heart failure patients at home using a wearable developed by ADI has shown in a new study that it may be able to reduce costly hospitalisations
Impact of EU sustainability directive on supply chains
European Pharmaceutical Review
MAY 13, 2024
Eighty four percent of pharmaceutical and healthcare companies consider that the new EU Corporate Sustainability Due Diligence Directive (CSDDD) directive is an opportunity to “align human rights and environmental protection with their business objectives”, findings from a survey by supply chain specialist INVERTO has found. EU operations must comply with the new directive.
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