US Vaccine Adverse Event Reporting System Not Meeting Standards
Drug Topics
NOVEMBER 16, 2023
VAERS was designed to collect reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for postmarket safety signals.
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Report: Measles cases and deaths increase worldwide, as childhood vaccinations rates decline
STAT
NOVEMBER 16, 2023
A dangerous decline in the rate of children vaccinated against measles is spurring a global increase in cases and deaths from the highly contagious virus, according to a report released Thursday. Estimated measles cases rose 18% to 9 million in 2022 when compared to the previous year, and deaths rose by 43% to 136,200, according to the report , jointly authored by the World Health Organization and the Centers for Disease Control and Prevention.
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Assessing a National Health Program to Prevent the Onset of Type 2 Diabetes in High-Risk Patients
Drug Topics
NOVEMBER 16, 2023
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.
STAT+: U.K. approves world’s first CRISPR-based medicine, giving greenlight to therapy for sickle cell, thalassemia
STAT
NOVEMBER 16, 2023
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.
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.
Vitamin D Deficiency Could Increase Chemo-Induced Neuropathy Risk in Patients With Breast Cancer
Drug Topics
NOVEMBER 16, 2023
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.
Key questions (and answers) about the historic approval of a CRISPR-based medicine
STAT
NOVEMBER 16, 2023
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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How the Bad River Tribe flipped the script on the Native American opioid crisis
STAT
NOVEMBER 16, 2023
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.
Language Barriers May Influence Diagnosis of Allergies in Children
Pharmacy Times
NOVEMBER 16, 2023
In addition to language barriers, pharmacy translation software errors may cause further complications when filling patient prescriptions.
Opinion: What antidepressants are saying 30 years after the publication of ‘Listening to Prozac’
STAT
NOVEMBER 16, 2023
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.
Bristol Myers' $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro
Fierce Pharma
NOVEMBER 16, 2023
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.
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: I worked for CMS. Even I struggle to help family navigate dual eligibility
STAT
NOVEMBER 16, 2023
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
Pharma is racing to oncology's first line, causing a rethink of early-stage disease treatment
Fierce Pharma
NOVEMBER 16, 2023
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.
STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant
STAT
NOVEMBER 16, 2023
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
US outpaces other wealthy nations in cost-related care deferment, with wide gaps between income levels
Fierce Healthcare
NOVEMBER 16, 2023
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.
5 Reasons to Upgrade Your Pharmacy Management Software
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Colon cancer screening kits have a high rate of untestable samples
STAT
NOVEMBER 16, 2023
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.
Early-Life Exposure to Manganese May Improve Neurobehavioral Outcomes
Pharmacy Times
NOVEMBER 16, 2023
While manganese can sometimes be considered toxic, prenatal exposure may be linked to better memory at adolescence.
Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries
Fierce Pharma
NOVEMBER 16, 2023
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
CMS tightening network adequacy standards for exchange plans
Fierce Healthcare
NOVEMBER 16, 2023
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.
STAT+: Bristol wins U.S. approval for lung cancer drug targeting rare genetic mutation
STAT
NOVEMBER 16, 2023
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.
What are the best antibiotics for a tooth infection?
The Checkup by Singlecare
NOVEMBER 16, 2023
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.
Retaining the human element of AI within pharma and healthcare
pharmaphorum
NOVEMBER 16, 2023
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.
AstraZeneca showed the pandemic isn’t over for immunocompromised patients. What’s next?
PharmaVoice
NOVEMBER 16, 2023
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.
Mayo Clinic has brought in $1.3B across 2023's first 9 months
Fierce Healthcare
NOVEMBER 16, 2023
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.
Expert: Price and Drug Negotiation Provisions Through the Inflation Reduction Act, Eliminating Costs
Pharmacy Times
NOVEMBER 16, 2023
Expert discusses changes health care professionals should know about drug coverage and out-of-pocket costs through the IRA
Progress in childhood cancer has stalled for Blacks and Hispanics, report says
STAT
NOVEMBER 16, 2023
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.
FDA Approves At-Home Collection System to Test for Chlamydia and Gonorrhea
Pharmacy Times
NOVEMBER 16, 2023
The approval marks the first authorized at-home sample collection test for sexually transmitted diseases.
Healthcare's Fundamental Challenge - OpusVi's Mission to Alleviate the Staffing Shortage
Fierce Healthcare
NOVEMBER 16, 2023
Dignity Health Global Education (DHGE) has officially transitioned to OpusVi to highlight its sole mission of eliminating the healthcare staffing shortage crisis. | DHGE has officially transitioned to OpusVi to highlight its sole mission of eliminating the healthcare staffing shortage crisis.
How do we know Alzheimer’s drugs ‘work’?
STAT
NOVEMBER 16, 2023
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, everyone. Damian here with an update on a thwarted gene therapy study, a head-to-head fight in GLP-1, and a critical look at Alzheimer’s treatment.
Understand the Emergency Management Assistance Comp
Pharmacy Times
NOVEMBER 16, 2023
This interstate agreement can empower pharmacists to respond to large-scale emergencies
How Digital Twins Drive Sustainability in Clinical Supply Planning
PharmExec
NOVEMBER 16, 2023
Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.
Listen: A CRISPR milestone, algorithms amok, & biotech mixology
STAT
NOVEMBER 16, 2023
Who polices algorithms? How would you name the first approved CRISPR medicine? And what pairs well with a biotech downturn? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Casey Ross joins us to tell the bombshell story of how the nation’s largest health insurer used a computer algorithm to deny patient care and boost its profitability.
Placer.ai weighs in on retail performance ahead of Black Friday 2023
Drug Store News
NOVEMBER 16, 2023
The lack of significant traffic spikes during major promotional events also indicate that most shoppers have yet to get into the holiday spending spirit, per Placer.ai.
First CRISPR-based gene-editing therapy authorised
European Pharmaceutical Review
NOVEMBER 16, 2023
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.
Fierce Pharma Asia—Novartis, Legend's CAR-T deal; Astellas' busy week; Ajinomoto's $620M purchase
Fierce Pharma
NOVEMBER 16, 2023
Novartis inked a solid tumor CAR-T deal with Legend Biotech. | Novartis inked a solid tumor CAR-T deal with Legend Biotech. Astellas is buying a biotech, working to understand deaths in its gene therapy trial and partnering up to drive drug discovery. Ajinomoto will buy a gene therapy CDMO. And more.
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