Fri.Aug 04, 2023

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FDA Gives 510(k) Clearance to COVID-19, Influenza A/B, RSV Combination Test

Drug Topics

A 510(k) clearance, or a Premarket Notification, requires device manufacturers to notify the FDA at least 90 days ahead of registration with their intent to market a medical device.

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mRNA-1273 Vaccine Associated With Lower Risk of Adverse Events, Likelihood of COVID-19 Diagnosis

Pharmacy Times

Compared to the BNT162b2 vaccine, the mRNA-1273 vaccine was associated with a lower risk of adverse events, which investigators speculate was due to interrelated safety and efficacy.

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Trending Sources

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Vitamin D Maintenance May Benefit Patients With Advanced Melanoma

Drug Topics

Nearly 25% of people “have vitamin D blood levels that are too low or inadequate for bone and overall health,” according to the NIH.

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CDC Advisory Committee on Immunization Practices Recommends Nirsevimab-alip to Prevent RSV in Infants

Pharmacy Times

CDC Advisory Committee on Immunization Practices voted 10 to 0 to recommend the routine use of nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns and infants.

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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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COPD Exacerbations Common in Patients Not Treated With Controller Medications

Drug Topics

A study found that although the number of patients receiving a controller medication increased after their first exacerbation, the percentage given controller medications remained below 50% among the overall population.

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Research Shows Smoking Status Is a Risk Factor for Hematoma Expansion

Pharmacy Times

The findings suggest that cigarette smoking is an independent predictor for the expansion of hematoma, although smoking status does not cause a difference in mortality.

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Aggressive Medical Management Can Reduce Risk of Stroke Recurrence in Black Adults

Pharmacy Times

Black adults, who have a higher likelihood of suffering from stroke at a young age, benefitted from blood pressure control and increased physical activity.

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Industry Voices—Let's treat loneliness like other public health crises

Fierce Healthcare

A silent and grossly underserved epidemic of loneliness is affecting 60% of all America | Numerous experts have called attention to our loneliness epidemic, describing its negative health impact as similar to “smoking 15 cigarettes a day.

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Patients With Transthyretin Cardiac Amyloidosis, Heart Failure With Preserved Ejection Fraction Have Similar All-Cause Death Rates

Pharmacy Times

Notably, patients with transthyretin cardiac amyloidosis had higher rates of heart failure hospitalizations, including patients treated with tafamidis.

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Don’t take these medicines with Benadryl

The Checkup by Singlecare

When you experience symptoms of allergies, hay fever, or the common cold, all you want is a solution—fast. Benadryl quickly relieves symptoms of red, itchy, watery eyes, sneezing, runny nose, cough, and an itchy throat. For some people, it can help manage symptoms of insomnia, Parkinson’s disease, or motion sickness. But before seeking relief from Benadryl, you should know it does have certain drug interactions.

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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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The Role of Specialty Pharmacists in Overcoming Barriers Associated With PCSK9 Inhibitors

Pharmacy Times

Specialty pharmacists play an important role in dispensing PCSK9 inhibitors and serve as a valuable source of assistance and education for patients.

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Data breach exposes information on 1.7M Oregon Health Plan members

Fierce Healthcare

State officials are urging members of the Oregon Health Plan to monitor their credit accounts as personal data on nearly 1.7 members was exposed as part of a massive data breach into a contractor.< | State officials are urging members of the Oregon Health Plan to monitor their credit accounts as personal data on nearly 1.7 members was exposed as part of a massive data breach into a contractor.

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Anticipating Adult RSV Infection Rates

Pharmacy Times

Dr Haumschild drives a discussion around what pharmacies and health care systems can expect from RSV infections in adult patient populations.

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Giant donates $100K to Helping Harvest Fresh Food Bank

Drug Store News

The donation will help provide more than 9,000 bags of food to be distributed to preschool and elementary children, designed to replace food that those kids would normally have received at school.

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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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Electronic Medical Record Utilization and Medicare Considerations for RSV Vaccines

Pharmacy Times

Electronic health record utilization and financial considerations for RSV vaccines in adults are overviewed by Drs Madison and Welch.

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Pandemic slowed cancer diagnoses, but late-stage cancers came back with a vengeance

STAT

Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types. This study is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captures over 70% of all cancers in the United States.

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What to Know About the Approval of Lecanemab-irmb

Pharmacy Times

Nikhil Palekar discusses the FDA approval of lecanemab-irmb (Leqembi, Eisai) and what this means for those who have Alzheimer Disease.

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STAT+: Medicare slashes safety net hospital payments on estimate that more people have insurance

STAT

The federal government will pay hospitals that treat poor and uninsured patients almost $1 billion less next year, a cut that’s more than eight times larger than the one proposed in April. The Centers for Medicare and Medicaid Services originally said it would cut payments meant to help safety net hospitals by $115 million in 2024. In the final rule released this week, however, that cut grew to $957 million.

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Oncology Pharmacists Influencing the MM Treatment Landscape

Pharmacy Times

Drs Haumschild, Anderson, and Hinojosa provide their closing thoughts regarding treatment considerations for patients with RRMM.

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LGBTQ+ adults more likely to delay, avoid care, Healthgrades survey finds

Fierce Healthcare

LGBTQ+ adults are less likely than cisgender, heterosexual adults to have had health screenings in the past year and are more likely to have skipped care, a new survey has found. | In the past year, 25% of LGBTQ+ adults did not have any health screenings, compared to 20% of cisgender, heterosexual adults.

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As Fewer Hospitals Report Cases of COVID-19, Wastewater Surveillance Could Be a Better Means of Estimating Countywide Infection Rates

Pharmacy Times

Wastewater surveillance could be the most consistent way to measure COVID-19 across US counties, a recent study indicates.

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STAT+: FDA approves Sage Therapeutics’ rapid-acting medication for postpartum depression but not major depression

STAT

The Food and Drug Administration on Friday approved a new, rapid-acting medicine made by Sage Therapeutics to treat postpartum depression, the first oral treatment for the condition. But the agency denied the company’s application for an indication for major depression, a much larger potential market. The drug, which will be sold under the brand name Zurzuvae, is not meant to be taken chronically.

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Unbalanced Sleep Patterns Could Impact Gut Bacteria

Pharmacy Times

Social jet lag could create adverse health impacts that a 90-minute difference in the mid-point of sleep can improve.

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Opinion: The high out-of-pocket cost of donating a kidney

STAT

“All of your medical and surgical expenses will be paid by your recipient’s insurance,” the nurse coordinator at the Mayo Clinic told me. Naïve, I nodded into the phone at this reassurance. I had already worked with her to have several vials of my blood shipped from my home in Kansas City to Mayo in Rochester, Minnesota, all at no cost to me.

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Walgreens Boots Alliance sells shares of AmerisourceBergen

Drug Store News

Walgreens Boots Alliance sold shares of AmerisourceBergen common stock through a registered public offering of approximately $1.6 billion. AmerisourceBergen also announced a registered public offering of 10.5 million shares of common stock.

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After tornado, Pfizer puts Rocky Mount meds on emergency ordering list to thwart hospital shortages

Fierce Pharma

In a bid to thwart shortages of critical hospital drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. | In a bid to thwart shortages of critical drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. The move comes after a tornado hit the company's injectables facility late last month, creating questions about potential supply disruptions.

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STAT+: For brain-computer interfaces, the commercial hurdles may be bigger than scientific ones

STAT

Rodney Gorham loves fast, flashy cars: His WhatsApp profile picture is a bright yellow Corvette Stingray. “I don’t get to drive it anymore,” Gorham told STAT in a text. Gorham, a 63-year-old living in Australia, has amyotrophic lateral sclerosis. He can’t speak, and can move his hands and legs only a little. In six months, he won’t be able to move at all.

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Galapagos scraps applications for Jyseleca in Europe and slashes sales projection

Fierce Pharma

And the hits just keep on coming for Galapagos. | Based on the results of a phase 3 study, Galapagos has decided not to submit a Marketing Authorization Application in Europe for Jyseleca (filgotinib) in Crohn’s disease. The company also will not proceed with its application for filgotinib in ulcerative colitis in Switzerland. Galapagos revealed the moves in reporting its first-half earnings.

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Optum taps CMS, Blue Cross NC veteran Conway to lead PBM unit

Fierce Healthcare

Optum Rx has a new leader at the helm. | Optum Rx has a new leader at the helm. Patrick Conway, M.D., will step into the role of CEO of the pharmacy benefit management giant.

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Amgen's hyped Humira biosimilar fritters away its exclusivity advantage

Fierce Pharma

In January, when Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunol | When Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunology powerhouse.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Lilly pressures Blueprint further with positive Retevmo trial in newly diagnosed lung cancer

Fierce Pharma

In their ongoing RET inhibitor rivalry, Eli Lilly is pulling further ahead of Blueprint Medicines, even as the latter company is being abandoned by Roche. | In their ongoing RET inhibitor rivalry, Eli Lilly is pulling further ahead of Blueprint Medicines, even as the latter company is being abandoned by Roche.

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Organization behind ProMed defends move to subscription-based model

STAT

The organization that runs ProMed , an early warning system on disease outbreaks, defended its plans to charge a subscription for its service on Friday, calling it “the only viable path forward” given the resources required to run it. In a lengthy statement , the head of the International Society for Infectious Diseases  (ISID) apologized for “any confusion and distress” caused by communication of the group’s plans.

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Monitoring for Treatment Toxicities Associated with Care for MM

Pharmacy Times

Navigating treatment toxicities is paramount to achieving treatment goals in MM management.

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