Wed.Mar 27, 2024

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Moderna’s Next-Gen COVID-19 Vaccine Outperforms Spikevax in Phase 3 Trial

Drug Topics

mRNA-1283 generated a stronger immune response against both the Omicron BA.4/BA.5 and the original virus strains of SARS-CoV-2 compared with Spikevax, Moderna’s licensed COVID-19 vaccine.

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Navigating the Psychedelic Renaissance: Emerging Mental Health Therapies and the Pharmacist’s Role

Pharmacy Times

Psychedelic medicines such as psilocybin, MDMA, ketamine, and LSD have been shown to have a significant impact on conditions such as major depressive disorder, generalized anxiety disorder, and post-traumatic stress disorder in clinical trials.

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Examining Trends in Long-Term Opioid Use, Importance of Pharmacist-Physician Collaboration

Drug Topics

At APhA 2024, 2 posters looked into how collaboration between physicians and community pharmacists is crucial when it comes to opioid prescriptions, and current opioid use patterns among older adults.

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Adjuvanted RSVPreF3 Vaccine Could Prevent RSV Infection Among Older Adults

Pharmacy Times

The adjuvanted RSVPreF3 vaccine could prevent nearly 3 million symptomatic RSV-ARI cases among US older adults over 3 years’ time, according to study results.

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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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Improving CVD Outcomes Through Better Recommendations, Patient Monitoring

Drug Topics

Researchers detailed the FDA’s recommendations on low-dose aspirin and pharmacists’ role in cardiovascular practice transformation programs.

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Pharmacy Focus: Policy Edition - Overview of California's Stop Dangerous Pharmacies Act

Pharmacy Times

Ron Lanton discusses California's Stop Dangerous Pharmacies Act, which aims to address understaffed chain pharmacies and reduce medication errors by implementing new regulations around pharmacy staffing, error reporting, and unsafe working conditions.

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Multiple sclerosis has distinct subtypes, study finds, pointing to different treatments

STAT

For years, researchers have been hopeful they could get under the hood of multiple sclerosis. The neurological condition shows up in over 2.5 million people around the world, but it doesn’t always look the same. If science could point its light in just the right way, patients might be sorted into disease subgroups, and treated more successfully depending on their kind of MS.

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FDA Warns Consumers About Unapproved, Misbranded OTC Analgesic Products

Drug Topics

The agency issued warning letters to 6 companies manufacturing these products.

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Gut bacteria could play role in kidney autoimmune disease, study shows

STAT

Right now, inside your digestive tract, there are trillions of bacteria, fungi, and viruses that form a tiny universe known as the gut microbiome. New research shows that certain bacteria can alter antibodies so much that they’re unrecognizable to the body’s defenses — potentially leading to immune friendly fire. The bacteria, called Akkermansia muciniphila, can strip the sugar coating from IgA antibodies, immune proteins abundant in the gut.

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FDA Issues Letters to 6 Companies for Unapproved, Misbranded OTC Analgesic Products

Pharmacy Times

The agency warns consumers against using these products, which are marketed for topical use to relieve pain associated with cosmetic procedures.

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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+: Borrowing an idea from cancer immunotherapy, scientists make old-mice immune systems youthful again

STAT

One of the indignities of getting older is the way your body’s defenses against microbes begin to break down, leaving you extra vulnerable to infection. Researchers studying the ways these systems change with age refer to them collectively as “immunosenescence,” or, more poetically, the “ twilight of immunity. ” But even as scientific understanding of the phenomenon has grown over the past decade, the forces driving it remain murky.

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FDA Approves Sotatercept-csrk for Pulmonary Arterial Hypertension

Pharmacy Times

Sotatercept-csrk is the first approved activin signaling inhibitor therapy for pulmonary arterial hypertension, which represents a new class of therapy.

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The Food is Medicine movement originators are trying to standardize medically tailored meals

STAT

WASHINGTON — Food corporations, grocery stores, and even tech companies are claiming they are a part of the growing effort to use food to treat medical conditions. Now, the nonprofits that pioneered the work want to standardize it. The Food is Medicine Coalition, an association of community-based nonprofit food providers, released a 32-page accreditation standard, which was shared first with STAT Wednesday.

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FDA Approves Sotatercept-csrk for Pulmonary Arterial Hypertension

Drug Topics

The drug had previously been granted a breakthrough therapy designation by the FDA.

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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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Brainomix AI shows its worth in AZ pulmonary fibrosis trial

pharmaphorum

Brainomix's e-Lung AI can accurately identify idiopathic pulmonary fibrosis patients most likely to progress and could inform the clinical trial design for new therapies

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Startup launches out of Redesign Health to rewrite the script on medication management

Fierce Healthcare

Are patients taking their medications? | Startup Scriptology launched to bring a new approach to medication management by combining an extended clinical pharmacist team with a technology platform to give patients more guidance and support to help them follow their medication plan.

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Building the patient experience into observational studies produces stronger real-world evidence

pharmaphorum

Incorporating the patient experience into observational studies can enhance the quality of real-world evidence gathered. Learn how patient-centred approaches can lead to stronger research outcomes.

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Pediatric mental health startup InStride Health picks up $30M to accelerate growth into new markets

Fierce Healthcare

Two years ago, startup InStride Health launched to provide mental health treatment for children and teens based on a program rooted in academic medicine, aiming to make high-quality care more acces | Two years ago, startup InStride Health launched to provide mental health treatment for children and teens based on a program rooted in academic medicine, aiming to make high-quality care more accessible to families.

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Akebia's Vafseo finally gets its shot at US chronic kidney disease market after FDA approval

Fierce Pharma

Akebia never lost confidence in its oral chronic kidney disease (CKD) anemia drug Vafseo, even after the FDA nixed its first approval bid two years ago with a complete response letter.

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Tenet Healthcare closes $975M sale of 4 hospitals to UCI Health

Fierce Healthcare

Tenet Healthcare has wrapped up its deal to sell four hospitals and their related outpatient sites to UCI Health, according to a Wednesday announcement academic system. | UCI Health said the acquisitions will help meet the “continually increasing demand for inpatient beds for a range of intensive and critical care needs” that until now was being met by its flagship, 459-bed UCI Medical Center.

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Sanofi inks 3 distribution pacts in India and Korea for CNS drugs and vaccines

Fierce Pharma

For various reasons, pharma firms often favor distribution pacts rather than relying on local subsidiaries to market their drugs. | As pharma firms increasingly favor distribution pacts rather than relying on local subsidiaries to market their drugs, French major Sanofi has enlisted local companies to enhance the profile of its medicines across South and East Asia.

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Japan clears first CLDN18.2 drug, Astellas’ Vyloy

pharmaphorum

Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment for stomach cancer. The Ministry of Health, Labour and Welfare (MHLW) has cleared Vyloy (zolbetuximab) for use in combination with chemotherapy for patients with HER2-negative CLDN18.2-positive advanced or recurrent gastric cancer that cannot be treated with surgery.

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GAO: Improper payments in federal programs neared $236B last year

Fierce Healthcare

A new report finds that the federal government made nearly $236 billion in improper payments across entitlement programs last year, with Medicare and Medicaid a large source of payment errors. | A new report finds that the federal government made nearly $236 billion in improper payments across entitlement programs last year, with Medicare and Medicaid a large source of payment errors.

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More revamp at Bayer as it axes 90 at its U.S. headquarters in New Jersey

Fierce Pharma

At a recent skull session in a conference room at Bayer’s U.S. | Bayer is laying off 90 of its employees at its United States headquarters in Whippany, New Jersey, part of its ongoing restructure which CEO Bill Anderson has said will cost many their jobs.

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CMS simplifying Medicaid, CHIP enrollment and renewal processes

Fierce Healthcare

The Centers for Medicare & Medicaid Services (CMS) released a final rule Wednesday to help individuals obtain and retain Children's Health Insurance Program (CHIP) coverage. | In a final rule set to take effect in two months, CMS is streamlining its Medicaid and CHIP eligibility, enrollment and renewal processes.

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Dissatisfaction with NHS ‘at record high’

pharmaphorum

More than half (52%) of people who participated in a major survey of the GB public were dissatisfied with the NHS, as staff shortages, strikes, and record waiting lists take their toll. The results from the annual British Social Attitudes (BSA) survey came from 3,000 people interviewed across England, Scotland, and Wales and showed that less than a quarter (24%) were satisfied with the health service, a 29 percentage drop in three years.

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Consumer protection group calls for ban on 'profit-gambit' facility fees

Fierce Healthcare

Facility fees are “clear profit-gambits” that take financial advantage of unsuspecting patients while failing to provide any benefits to them. | A new report calls for a total ban on so-called facility fees that can surprise patients while offering no benefits.

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Reuters Pharma USA 2024 - Day 2

pharmaphorum

Get live coverage of the latest updates and developments from Day 2 of Reuters Pharma USA 2024. Stay informed with real-time news and insights from the event.

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Nirmatrelvir/Ritonavir in Patients With Hematologic Malignancies Improves COVID-19 Outcomes

Pharmacy Times

Early treatment administration with this regimen also promoted a faster decrease in viral load and shorter viral shedding in patients with hematologic diseases who were positive for COVID-19.

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WuXi Biologics stays the course with positive 2024 outlook as national security crackdown threatens business in US

Fierce Pharma

WuXi Biologics stays the course with positive 2024 outlook as national security crackdown threatens business in US fkansteiner Wed, 03/27/2024 - 13:12

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Brazil’s plan for low-cost CAR-Ts

STAT

New biotech newsletter launching tomorrow. Don’t miss out. Good morning, everyone. Damian here with the details on a potentially major drug approval, an idea to make CAR-T more equitable, and the slow launch of a gene therapy.

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Understanding the politics of drug pricing in the United States

pharmaphorum

Brandon Newman, CEO of healthcare analytics firm Xevant, joins host Jonah Comstock on today’s episode of the pharmaphorum podcast.

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Leveraging Digital Tools to Optimize Manufacturing Processes

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses how companies can leverage digital tools like artificial intelligence and machine learning to optimize manufacturing processes and ensure efficient production.

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Women in Science: Follow your passion and you’ll get to where you’re meant to be - Jennifer Visser-Rogers

Outsourcing Pharma

From math hater to a leader in clinical data, itâs been a long journey for Jennifer Visser-Rogers, vice president for statistical research and consultancy at Phastar.

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