Thu.Nov 16, 2023

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US Vaccine Adverse Event Reporting System Not Meeting Standards

Drug Topics

VAERS was designed to collect reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for postmarket safety signals.

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New Survey Indicates 42% of Primary Care Physicians Unfamiliar with Asthma Treating Biologics

Pharmacy Times

The study also found that 82% of the surveyed physicians reported not getting labs to help determine treatment options for their patients.

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STAT+: U.K. approves world’s first CRISPR-based medicine, giving greenlight to therapy for sickle cell, thalassemia

STAT

LONDON — Regulators in the U.K. on Thursday approved a CRISPR-based medicine to treat both sickle cell disease and beta thalassemia, making it the world’s first therapy built on the revolutionary gene-editing technology and ushering in a new phase of genetic medicine.   The authorization of the therapy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is itself not a surprise.

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Language Barriers May Influence Diagnosis of Allergies in Children

Pharmacy Times

In addition to language barriers, pharmacy translation software errors may cause further complications when filling patient prescriptions.

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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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How the Bad River Tribe flipped the script on the Native American opioid crisis

STAT

BAD RIVER RESERVATION, Wis. — Sunlight is streaming through holes in the walls of a disused, corrugated metal shack, revealing its modest insides: Dirt floors, stacks of two-by-fours, and a pile of Little Caesars pizza boxes under attack by a work crew on lunch break. This building is clearly not ready to be a home. But in the next 24 hours, it must become one.

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Early-Life Exposure to Manganese May Improve Neurobehavioral Outcomes

Pharmacy Times

While manganese can sometimes be considered toxic, prenatal exposure may be linked to better memory at adolescence.

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More Trending

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Vitamin D Deficiency Could Increase Chemo-Induced Neuropathy Risk in Patients With Breast Cancer

Drug Topics

In a population of 1191 patients with early-stage breast cancer, 20.7% of patients with a vitamin D deficiency experienced grade 3 or higher sensoryCIPN.

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Key questions (and answers) about the historic approval of a CRISPR-based medicine

STAT

History just happened. For the first time, a regulator has cleared a treatment using CRISPR , the gene-editing technology, for patients. The regulator is the United Kingdom’s Medicines and Healthcare products Regulatory Agency. The product is Casgevy, a treatment for sickle cell disease and beta thalassemia, two blood disorders. It was developed by CRISPR Therapeutics, the Swiss company co-founded by Nobel laureate Emmanuelle Charpentier, and Vertex Pharmaceuticals, a large Boston-based b

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Understand the Emergency Management Assistance Comp

Pharmacy Times

This interstate agreement can empower pharmacists to respond to large-scale emergencies

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Opinion: What antidepressants are saying 30 years after the publication of ‘Listening to Prozac’

STAT

In 1993, I published “Listening to Prozac,” a book that grew out of my clinical experience prescribing what was then a new class of medications, ones thought to moderate depression through their effect on the way that the brain handles the neurotransmitter serotonin. Some of my patients had reported marked favorable reactions to the drugs — first Prozac and, soon after, Zoloft.

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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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FDA Approves At-Home Collection System to Test for Chlamydia and Gonorrhea

Pharmacy Times

The approval marks the first authorized at-home sample collection test for sexually transmitted diseases.

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Opinion: I worked for CMS. Even I struggle to help family navigate dual eligibility

STAT

Three months ago, my aunt Margaret had a stroke. Days before, she was repainting her bathroom and driving herself. Now, she needs help with dressing and getting in and out of bed, and our family is grappling with the fact that this fiercely self-sufficient woman will never live independently again. This health crisis has been compounded at every turn by failures of the health care system — failures that are particularly infuriating to me because I have devoted my life to solving these ver

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Expert: Price and Drug Negotiation Provisions Through the Inflation Reduction Act, Eliminating Costs

Pharmacy Times

Expert discusses changes health care professionals should know about drug coverage and out-of-pocket costs through the IRA

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STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant

STAT

Dr. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S. Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems. In a recent inspection report , the agency found several notable failures, such as major production equipment that was not appropriately cleaned; a quality-control unit that did not investigate

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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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Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries

Fierce Pharma

Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries fkansteiner Thu, 11/16/2023 - 11:08

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Rx Product News - November 2023

Pharmacy Times

The products include Crovalimab, Dapagliflozin, Secukinumab, Roflumilast

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Bristol Myers' $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro

Fierce Pharma

Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. | Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market.

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The Role of Tirofiban for Acute Coronary Syndrome Remains Unclear

Pharmacy Times

The RESCUE BT2 trial sheds further light on the agent’s potential.

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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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Pharma is racing to oncology's first line, causing a rethink of early-stage disease treatment

Fierce Pharma

Timothy Yap, Ph.D., used to see patients nearing the end of their cancer journey in his phase 1 department at the University of Texas' MD Anderson Cancer Center. | Cancer drugs are getting better thanks to innovation, driven by the data and regulatory forces like Project FrontRunner.

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Assessing a National Health Program to Prevent the Onset of Type 2 Diabetes in High-Risk Patients

Drug Topics

An analysis on the Diabetes Prevention Program in England found it was effective at improving key cardiovascular risk factors, including glycated hemoglobin and excess body weight.

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Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy?

Fierce Pharma

Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy?

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Colon cancer screening kits have a high rate of untestable samples

STAT

More than a tenth of fecal immunochemical tests, used for routine colorectal cancer screening, contained samples that could not be processed by labs, according to a study published this week in Cancer Epidemiology, Biomarkers and Prevention, a journal of the American Association for Cancer Research. This is over twice the amount recommended by the U.S.

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US outpaces other wealthy nations in cost-related care deferment, with wide gaps between income levels

Fierce Healthcare

Another international survey has painted Americans’ access to care in a poor light when compared to those living in other wealthy countries, particularly when looking at disparities in residents’ i | Nearly half of surveyed U.S. adults with average or lower incomes said they had a cost-related reason for skipping medical care during the prior 12 months, versus 29% of those with higher incomes.

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STAT+: Bristol wins U.S. approval for lung cancer drug targeting rare genetic mutation

STAT

The Food and Drug Administration on Wednesday approved a new treatment for people with non-small cell lung cancer that contains a rare genetic alteration called Ros1. The genetically targeted medicine, called Augtyro, will be sold by Bristol Myers Squibb. It was developed by a small biotech company, Turning Point Therapeutics, that was acquired by Bristol in June 2022.

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CMS tightening network adequacy standards for exchange plans

Fierce Healthcare

Beginning in 2025, health plans sold in state-run insurance exchanges would be required to meet time and distance standards that are at least as adequate as mandated on federal marketplaces, accord | State insurance exchanges would be required to meet the same standards as federal exchanges under a new rule by CMS on Wednesday.

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AstraZeneca showed the pandemic isn’t over for immunocompromised patients. What’s next?

PharmaVoice

Dr. Paul Moss, a hematology expert in the U.K., conducted a study with AstraZeneca showing the alarming extent to which immunocompromised patients are burdened with COVID-19.

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Mayo Clinic has brought in $1.3B across 2023's first 9 months

Fierce Healthcare

Mayo Clinic pulled in $302 million of operating income (6.8% operating margin) during the third quarter, raising the organization’s year-to-date up to $751 million (5.7% operating margin), accordin | A rock-solid 6.8% operating margin for the quarter came courtesy of continued strong demand, stabilizing workforce issues and a focus on performance improvement, leadership said.

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What are the best antibiotics for a tooth infection?

The Checkup by Singlecare

When you have a bacterial infection, like strep throat or a urinary tract infection, an antibiotic is often the solution to the problem. The antibiotic eliminates the bacteria causing your symptoms. With a tooth infection, also known as a dental abscess or abscessed tooth, you may need an antibiotic and an additional procedure—depending on how severe the situation is.

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Humana: How value-based care can improve the patient, provider experience

Fierce Healthcare

Value-based care leads to a better patient experience — and a better experience for physicians, too, a new study from Humana shows.

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Life sciences inspections and investigations

pharmaphorum

Life sciences inspections and investigations Mike.

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First CRISPR-based gene-editing therapy authorised

European Pharmaceutical Review

Casgevy (exagamglogene autotemcel), also known as exa-cel, is the first treatment to be licensed that uses CRISPR. It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia.

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Retaining the human element of AI within pharma and healthcare

pharmaphorum

In this episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Venu Mallarapu, vice president of global strategy and operations at eClinical Solutions, about the ins and outs of successful AI implementation within pharma and healthcare.

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Progress in childhood cancer has stalled for Blacks and Hispanics, report says

STAT

Advances in  childhood cancer  are a success story in modern medicine. But in the past decade, those strides have stalled for Black and Hispanic youth, opening a gap in death rates, according to a new report published Thursday. Childhood cancers are rare and treatments have improved drastically in recent decades, saving lives.

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