Tue.Sep 12, 2023

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COVID-19 Pandemic May Have Led to a Reduction in Skin Cancer Screening Access

Drug Topics

A study indicates that possible disruptions in skin cancer screenings and general dermatologic care at the time of the pandemic could have resulted in fewer diagnoses of melanoma generally.

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Study Shows Not All IVIG Products Are Created Equal in Alzheimer Disease

Pharmacy Times

One IVIG product showed overall improvement in neuroprotection, including alleviating cognitive decline and ameliorating AB deposition in Alzheimer disease.

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GLP-1 Demand to Continue Increase as More Benefits Are Discovered

Drug Topics

Drugs like Ozempic and Wegovy, two semaglutide products made by Novo Nordisk, as well as Mounjaro (tirzepatide), mimic a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake.

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Resistance Mechanisms, Host Interactions Remain Elusive for Clostridioides difficile Research

Pharmacy Times

Investigators said that understanding virulence factors, resistance mechanisms, and host interactions can help establish the development of novel therapeutics for Clostridioides difficile.

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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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Community Needs Must be Met to Bridge Gaps in Health Care Disparity

Drug Topics

Sampson Davis, MD, the keynote speaker for the 2023 PBMI Annual National Conference, discussed how the health care system needs to build trust and tailor approaches that meet community needs.

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CDC recommends updated Covid vaccines for everyone 6 months and older

STAT

A panel of advisers to the Centers for Disease Control and Prevention voted 13-1 Tuesday to recommend updated Covid-19 booster shots for all Americans 6 months and older. CDC Director Mandy Cohen signed off on the recommendation hours later, and vaccines would be available within 48 hours. The recommendation applies to mRNA shots from Pfizer-BioNTech and Moderna, both of which were approved by the Food and Drug Administration Monday.

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The food industry has tried to stack a key nutrition policy panel with its preferred experts, documents show

STAT

WASHINGTON — There’s a panel of 20 nutrition experts that has outsized influence on the American diet — and the food industry has worked hard to get friendly researchers into the group, new documents obtained by STAT show. The National Potato Council, for example, nominated one of the researchers behind an industry-funded study showing eating french fries each day doesn’t result in more weight gain than eating a comparable amount of almonds.

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Geisinger doubles down on collaboration with Best Buy Health, Geek Squad to support tech-driven care in the home

Fierce Healthcare

As at-home healthcare becomes more tech-driven—think wireless biosensors and connected blood pressure cuffs—it creates more logistical challenges for providers. | Geisinger's pilot program with Best Buy's Geek Squad resulted in quicker access to care, better adherence to care plans and more positive outcomes for chronic care patients, the organizations said.

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STAT+: Here are the dozens of weight loss drugs in development to catch a booming market

STAT

The blazing success of weight loss drugs like Wegovy and Mounjaro has electrified the pursuit of new treatments for obesity. For now, Novo Nordisk and Eli Lilly are leading the market with injectable drugs that target receptors of the GLP-1 hormone to mimic the hormone’s effects of helping people feel full. But dozens of companies are also jumping into the race, seeing the potential to make millions of dollars if they can bring to market medications that are oral, longer-lasting, avoid si

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CDC starts ‘Wild to Mild’ campaign to reverse falling flu vaccine use in key groups

Fierce Pharma

The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.

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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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Popular nasal decongestant doesn’t actually relieve congestion, FDA experts say

STAT

WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications stocked on store shelves.

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Developing an effective contamination control strategy

European Pharmaceutical Review

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scienti

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Food companies to regulators: Please don’t worry about ultra-processed anything

STAT

WASHINGTON — The food industry is anxious that regulators are focusing too much on the health impacts of so-called ultra-processed foods, the popular, ill-defined food group that includes everything from hot dogs and chicken nuggets to cookies and potato chips. Frozen food makers and the meat industry on Tuesday, speaking to a panel of nutrition experts tasked by the federal government with advising on the next round of the national dietary guidelines, raised concerns with its focus on th

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Neuraminidase Inhibitors, Endonuclease Inhibitors Significant for Influenza Pandemics, Foundational for Further Antiviral Support

Pharmacy Times

Having 2 drug classes available for influenza is significant, but it is important to investigate other treatments prior to the pandemic, a new study indicates.

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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+: FDA proposes changes to key approval pathway for medical devices, five years after promising

STAT

Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) program that has long been lambasted for letting risky devices fall through the cracks. Most medical device companies do not have to test their products on people in order to secure clearance from the FDA — they simply have to show they’re “substantially equivalent” to devi

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New AMA report slams PBM industry for lack of competition

Fierce Healthcare

PBMs used solely by insurers with which they’re affiliated with cannot be considered viable options for other nonaffiliated insurers, the AMA says.

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Opinion: Patients might finally receive practical information with prescriptions — if the FDA doesn’t blow it

STAT

Patients often ask two questions about every medical treatment: Will it help me? Will it hurt me? The Food and Drug Administration knows many of the answers. It wants patients to know them, too. After years of deliberation, the FDA has proposed giving patients a simple one-pager for every prescription drug with the information needed for safe and effective use.

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MorningRX: September 12, 2023

Drug Topics

CDC to weigh who should get updated COVID-19 vaccines after FDA approval, Novavax says its updated COVID-19 vaccine is ready for distribution, and Walgreens partners with Pearl Health to expand primary care services.

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STAT+: New obesity drugs are in the works trying to out-blockbuster Wegovy and Mounjaro

STAT

The exploding popularity of drugs like Wegovy and Mounjaro has propelled dozens of companies to develop their own obesity treatments, with most of them trying to emulate the same approach as the blockbuster products. Nearly 70 obesity treatments are in development, and about two-thirds use a similar mechanism as Wegovy and Mounjaro, according to the STAT Obesity Drug Tracker , a new database compiled by STAT.

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In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

Fierce Pharma

Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. | The companies included in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.

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STAT+: Nick Leschly departs Bluebird Bio spinout amid restructuring, layoffs

STAT

Some two years after splitting biotech company Bluebird Bio into two entities in a bid to “sharpen their focus” and improve operations, the spinout focused on oncology treatments announced major cost cuts and is parting ways with its chief executive. The spinout, 2Seventy Bio, announced Tuesday that it is cutting approximately 40% of its workforce, or about 176 employees.

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GoodRx, Walgreens team to lower prices for 200 drugs

Fierce Healthcare

GoodRx is teaming up with Walgreens to offer further discounts on 200 drugs at its pharmacies. | GoodRx is teaming up with Walgreens to offer further discounts on 200 drugs at its pharmacies.

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STAT+: Walmart may buy concierge Medicare Advantage provider ChenMed. But will it scale?

STAT

Walmart seems poised to increase its health care footprint by buying value-based senior care company ChenMed, per reports from Bloomberg. Experts largely hailed the rumored sale as a good buy, citing the management of chronic conditions in the Medicare Advantage population through primary care, ChenMed’s specialty, as an area with huge innovation and cost savings over the last 10 years.

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Xspray, seeking FDA approval for its Sprycel competitor, settles patent lawsuit with BMS

Fierce Pharma

Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. | Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday. The deal clears “all pending claims” and tees up a potential Dasynoc launch on Sept. 1, 2024, or potentially earlier under certain circumstances.

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What side effects to expect from the shingles vaccine

The Checkup by Singlecare

Around the time you turn 50, you’ll need to step up your healthcare routine to avoid things like shingles, a painful infection that causes a viral rash. Luckily, there’s a shot to help prevent it: Shingrix, the shingles vaccine. “The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California.

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Researchers Connect High Particulate Matter Levels to Development of Breast Cancer

Pharmacy Times

Researchers found an increased risk of breast cancer in women who had higher particulate matter levels near their home.

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STAT+: Pharmalittle: Is Pascal Soriot leaving AstraZeneca? PBMs try to counter congressional crackdown

STAT

Hello, everyone, and nice to see you again after our extended break. A little time away is always a good thing, but now we have returned to our usual routine. Of course, we are starting by firing up the coffee kettle to concoct a few cups of stimulation. Our choice today is cinnamon sticky bun. You can never be too sweet, you know? Meanwhile, we have, once gain, gathered a few tidbits for you to peruse.

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Implementing the future of mRNA therapeutics

European Pharmaceutical Review

The next generation of therapeutics has arrived: from simple design and development to theoretically unlimited targets, messenger RNA ( mRNA )‑based therapeutics offer a multitude of benefits. However, creating these innovative treatments harbours challenges. This article explores common developmental and design issues and how to mitigate difficulties before they occur.

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Visory Health focuses on offering low cost prescription medications for women, caregivers

Drug Store News

Visory Health shared that over a year, it has enabled more than 3.25 million customers to access their essential medications while saving them over $4 billion.

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AI to revolutionise drug development by 2026

European Pharmaceutical Review

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Data predicted that in 2030, more than half of US Food and Drug Administration (FDA)-approved drugs will involve AI in their development and/or manufacturing.

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Despite a Lack of US Guidelines, Implementing ?-Lactam Therapeutic Drug Monitoring Remains Key

Pharmacy Times

This step-by-step primer describes the implementation process for β-lactam TDM.

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Novel vaccine delivers significant survival in lung cancer trial

European Pharmaceutical Review

A T-cell epitope cancer vaccine significantly improved overall survival in non-small cell lung cancer (NSCLC) compared to chemotherapy, Phase III data published in Annals of Oncology has shown. The immunotherapy activating tumour specific T-cells, off-the-shelf, neoepitope-based vaccine Tedopi ® was evaluated in HLA-A2 positive patients with advanced or metastatic NSCLC in monotherapy in third line NSCLC with secondary resistance to immune checkpoint inhibitors, in the Phase III clinical trial A

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Technician Product Verification Benefits Patients, Pharmacists, Technicians 2023

Pharmacy Times

Empowering technicians can enhance overall pharmacy management and promote a culture of patient safety.

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FDA approves Pfizer-BioNTech’s Omicron XBB.1.5-adapted Covid-19 vaccine

Pharmaceutical Technology

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

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