Wed.Mar 27, 2024

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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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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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Trending Sources

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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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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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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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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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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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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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Assessing How COVID-19 Impacted Pharmacists’ Work Activities, Job Satisfaction

Drug Topics

Two posters presented at APhA 2024 examined how the COVID-19 pandemic impacted pharmacists and their work.

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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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STAT+: AstraZeneca sues Arkansas over the role of pharmacies in a federal discount drug program

STAT

AstraZeneca filed a lawsuit seeking to block an Arkansas law that requires the company to ship its medicines to any pharmacy working with hospitals participating in a controversial federal discount program. The move comes less than a month after a U.S. appeals court upheld the same law, but the company is trying to make a different argument in hopes of stopping other states from pursuing similar laws.

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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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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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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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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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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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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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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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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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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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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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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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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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Improvements Made in Stem Cell Transplant for Older Patients With AML Since 2000

Pharmacy Times

A study that analyzed data from 2000 to 2021 indicated improvements for both leukemia-free survival and overall survival for older patients with acute myeloid leukemia.

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Optum to buy struggling Steward Health Care's physician group under proposed deal

Fierce Healthcare

Steward Health Care is planning to sell off its physician group to UnitedHealth Group’s Optum in order to right its struggling finances, according to documents filed with Massachusetts state regula | The proposed deal is under review from Massachusetts' healthcare regulator, but has already drawn antitrust concerns from federal lawmakers who pointed to Optum's major share of the physician staffing market.

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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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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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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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STAT+: Pharmalittle: We’re reading about abortion pill arguments, a Merck drug approval, and more

STAT

Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far, because it is an accomplishment, after all. The next step, of course, is to forge ahead. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup or three of stimulation. Our choice today is caramel crème brulée.

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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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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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First-in-class biologic approved for rare lung disease

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). According to Merck (MSD outside of the US and Canada), WINREVAIR is the first activin signalling inhibitor therapy authorised for PAH.

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Prioritizing women, promoting diversity and a patient-first approach - how does CTM do it?

Outsourcing Pharma

OSP senior editor, Liza Laws, took some time at SCOPE 2024 in Orlando earlier in the year to speak with two female-focused members of the Clinical Trials Media (CTM) team, Katherine Seay and Veronica Berk to find out how.

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Heidelberg Pharma gains FDA ODD for ATAC candidate

Pharmafile

Heidelberg Pharma has announced that it has gained Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for HDP-101 for the treatment of multiple myeloma. The candidate is currently being investigated in a phase 1/2a clinical trial for the treatment of relapsed and refractory multiple myeloma (RRMM). HDP-101 is an antibody-drug conjugate […] The post Heidelberg Pharma gains FDA ODD for ATAC candidate appeared first on Pharmafile.

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Teva UK partners Closed Loop on personalised medicine

pharmaphorum

Teva UK has joined forces with techbio company Closed Loop Medicine to develop digital companions for pharma products that could provide personalised medicine

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FDA approves Merck’s Winrevair for PAH treatment

Pharmafile

Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) has approved Winrevair (sotatercept-csrk) for the treatment of adult patients with pulmonary arterial hypertension (PAH). The drug is intended to increase exercise capacity, improve World Health Organization (WHO) functional class (FC) and reduce risk of […] The post FDA approves Merck’s Winrevair for PAH treatment appeared first on Pharmafile.

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