Wed.Sep 04, 2024

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FDA Clears New Disposable Insulin Patch Pump For Patients With T1D and T2D

Drug Topics

Embecta’s new patch pump offers a larger insulin reservoir to better accommodate for the needs of patients with type 2 diabetes (T2D).

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Trying to time your seasonal vaccines just right? There are no easy answers, but here are some factors to consider

STAT

With fall coming into view, public health officials across the country are turning to the annual task of persuading legions of Americans to get vaccinated against some combination of influenza, Covid-19, and respiratory syncytial virus, three bugs that sicken mass numbers of people over the winter months, often overwhelming hospitals and health care delivery in the process.

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FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder

Drug Topics

DaylightRX from Big Health is a digital formulation of cognitive behavioral therapy and is available by prescription only.

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Moderna reports encouraging results on its mpox vaccine, as outbreaks in Africa spread

STAT

The emergence of a second mpox outbreak in which the virus is spreading from person-to-person, as well as a sharp increase in overall cases of the disease in several African countries, is straining the world’s capacity to make and distribute vaccine to battle the threat. New options are needed, and a study published Wednesday suggests another may be on the horizon.

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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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Tolebrutinib Shows Reduction in Disability Accumulation in Non-Relapsing Secondary Progressive Multiple Sclerosis

Pharmacy Times

In a promising development in multiple sclerosis research, tolebrutinib delayed the onset of disability progression in patients with nrSPMS.

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Inside the bruising battle to purge race from a kidney disease calculator

STAT

There it was on James Cannon’s lab report, two tiny words: African American. The words sat next to a number estimating how badly Cannon’s kidneys were failing. And they were definitely failing. His number read 37, less than half of what is considered normal for adults. Oddly, he thought, a different number labeled “if not African American” read even lower: 31.

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Women Who Receive False Positive Mammography Results Are Less Likely to Attend Follow-Up Screenings

Pharmacy Times

The authors stress that health care providers should explain false positive results to their patients, reassure them that results may be negative, and stress the significance of continued screenings.

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Birth control has become harder to get. New York has some creative solutions

STAT

A typical vending machine on a university campus might offer students the usual range of sodas, Sunchips, and Skittles. But a vending machine installed earlier this year at SUNY Upstate Medical University in Syracuse, New York, has a unique offering: Plan B pills. The vending machine, located in the campus library, is an effort to ensure that emergency contraceptives are affordable and accessible to the student body, with the Plan B pill costing as little as $10, compared to typical costs of $40

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Clinical Updates in Alirocumab Injection

Pharmacy Times

Alirocumab (Praluent; Regeneron), is a PCSK9 inhibitor indicated for the treatment of adults with heterozygous familiar hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease.

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STAT+: Humana cutting Medicare Advantage plans that cover 10% of members

STAT

Roughly 10% of people enrolled in Humana’s private Medicare plans will have to find new coverage for next year as the company trims its offerings in what’s become a turbulent corner of the industry.  Humana, the country’s second largest Medicare Advantage insurer, is aggressively culling its plan offerings after several quarters of spending more than expected on its members’ medical care, and getting hammered on Wall Street for it.

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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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FDA Grants Regenerative Medicine Advanced Therapy Designation for OBX-115

Pharmacy Times

OBX-115 could offer further treatment options for individuals with advanced or metastatic melanoma by enhancing persistence, antitumor activity, and clinical safety of TIL cell therapy.

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Opinion: The Snoo can’t help the people who need it most

STAT

When you have a baby, sleep becomes the holy grail. You become convinced that getting your baby to go the hell to sleep depends on the right swaddles, the right pacifier, the right settings on the white noise machine, the right order of events. If a routine gets disrupted or a special object misplaced, you fear that the kid will be awake for days, and thus, so will you.

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Study: Birthing People With IDD Are Younger With Poorer Obstetric, Mental Health

Pharmacy Times

The findings demonstrate a need for additional health care provider training and resources for birthing people with intellectual and developmental disabilities.

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Humana exiting Medicare Advantage in 13 markets

Fierce Healthcare

Humana reaffirmed its full-year guidance but is leaving 13 Medicare Advantage (MA) markets next year, Chief Financial Officer Susan Diamond said during the Wells Fargo Healthcare Conference on Wedn | Humana is pulling back from Medicare Advantage markets and cutting benefits next year. The insurer expects it will lose thousands of members and supplemental benefit utilization will be high toward the end of this year.

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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+: Novartis to spend $200 million in further bid to boost radiopharma manufacturing, market dominance

STAT

Novartis is opening a new manufacturing facility in California and expanding an existing production site in its bid to dominate the booming radiopharmaceuticals field amid burgeoning competition. The pharmaceutical giant will spend more than $200 million to construct the new facility in Carlsbad, Calif., and expand its site in Indianapolis, representatives told STAT exclusively.

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RedSail Technologies and the RxCash+ Tool

Drug Topics

Kristen Hartzell, PharmD, Vice President of Clinical Services, RedSail Technologies, sat down with Drug Topics to discuss the RxCash+ tool designed to achieve fairer pricing on cash prescriptions for pharmacies and patients.

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Bridging Health Equity: Addressing Heart Failure in Native American Communities

Pharmacy Times

New insights into heart failure risks in Native American communities are highlighting the need to address social determinants of health.

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Biogen to seek approval for high-dose version of SMA stalwart Spinraza after trial win

Fierce Pharma

Over the last decade, three blockbuster drugs—Biogen’s Spinraza, Roche’s Evrysdi and Novartis’ gene therapy Zolgensma—have transformed the treatment landscape for spinal muscular atrophy (SMA). | Biogen revealed that a portion of its phase 2/3 DEVOTE study met its primary endpoint, as a higher dose of Spinraza improved the motor function of treatment-naive infants with spinal muscular atrophy.

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Birth control vending machines, seasonal shots, and the “Snoo”

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! Is your blue my blue? The STAT newsroom was lit up over this existential question yesterday. This test attempts to determine at which hue you perceive the boundary between green and blue to be. The more design-oriented staffers especially didn’t like the binary nature of the task.

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Astellas Gene Therapies to turn out the lights at South San Francisco production plant

Fierce Pharma

Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a Californ | Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a California production plant.

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Medicaid redeterminations still affecting Centene as stock plunges

Fierce Healthcare

Centene’s business is still impacted by Medicaid redeterminations, a process that began in early 2023, the company said during the Wells Fargo Healthcare Conference. | Centene's stock sunk Wednesday after the company highlighted issues it faces surrounding Medicaid redeterminations.

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Depression: How brain scans helped predict long-term treatment outcomes

STAT

Depression has many faces. Some people can’t sleep, while others struggle to get out of bed. Even though symptoms and severity can vary from person to person, a recent study found that a specific brain circuit might be associated with the mental malady.  Located in the prefrontal cortex, the brain’s cognitive control circuit plays a part in our attention, goal-setting behavior and other executive functioning.

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Minimizing plastics use and risk in healthcare 

Fierce Healthcare

Microplastics are everywhere, including our bodies. | In this week's episode of "Podnosis," two experts break down the history of plastics use in the healthcare sector and what it would take for an organization to phase them out.

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BioMarin’s big day today

STAT

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. If your local deserted mall were to be shut down, would you rather it be turned into a shiny new arena for your basketball team or a shiny new biomedical innovation hub? That’s apparently the dilemma the business community is facing in Philadelphia.

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Evernorth's Accredo to make Stelara biosimilar available at $0 out-of-pocket

Fierce Healthcare

Evernorth's Accredo specialty pharmacy will offer biosimilars for the popular immunotherapy Stelara at $0 for eligible patients, the company announced Thursday. | Evernorth's Accredo specialty pharmacy will offer biosimilars for the popular immunotherapy Stelara at $0 for eligible patients, the company announced Thursday.

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Roche trumpets new fenebrutinib data in relapsing MS

pharmaphorum

Data from a phase 2 trial of Roche's oral BTK inhibitor fenebrutinib have shown "near-complete suppression" of disease activity and disability progression in relapsing multiple sclerosis (MS).The full results of the FENopta open-label extension study are due to be reported in full at the ECTRIMS congress in Copenhagen later this month, but top-line findings include that 99% of patients treated with fenebrutinib were free of T1 gadolinium-enhancing lesions, markers of active inflammation, at 48 w

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How to relieve sinus pressure in your ears

The Checkup by Singlecare

Anyone who has ever woken up with a stuffy or runny nose has gone through the same thought process before getting up and reaching for a tissue: First, they hope it’s just the common cold or allergies. And second, they hope it’s not a sinus infection. Why? Unlike colds, which are caused by a virus and can be pesky but work themselves out in a day or two, sinus infections are bacterial and often stick around for ten days or more and come with symptoms like nasal congestion , postnasal drip , facia

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Digital Therapeutic Shows Significant Reduction in Episodic Migraine

Drug Topics

Click Therapeutics announced that CT-132 met its primary endpoint in the phase 3 ReMMi-D trial.

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How to optimize efficiencies at site-centric clinical trials

Pharmaceutical Technology

By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.

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DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continue

Fierce Pharma

With a shortage of ADHD drugs persisting, the DEA has raised production limits on Takeda’s Vyvanse and its generic versions by 24%, the agency said.

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Biosimilar of Xolair shows Similarity in Reducing Asthma Exacerbations

Pharmacy Times

P043 is currently approved for patients 6 years and older with moderate to severe persistent allergic asthma whose disease is inadequately controlled with inhaled corticosteroids.

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Advocates rush to Congress, White House to extend telehealth prescribing for two years, after DEA's plans leaked

Fierce Healthcare

The Drug Enforcement Administration is reaching the final steps of its proposed rulemaking process for the prescription of controlled substances via telehealth, but its plans have been le | The Drug Enforcement Administration was expected to publish its proposed telehealth prescribing rule in September. A former official shared the agency's plans, which shattered the expectations of stakeholders.

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Digital skills: Why private clinics need effective communication lines to bridge the growing digital divide

pharmaphorum

Digital skills: Why private clinics need effective communication lines to bridge the growing digital divide Mike.

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Tramadol and Fluoxetine Interaction

Med Ed 101

JS is a 58-year-old female who has taken tramadol (podcast) for years due to chronic back pain. She has been experiencing worsening symptoms of depression and has been tried on duloxetine and sertraline in the past. Both of these medications caused GI upset and she is not interested in retrying these medications. The primary provider […] The post Tramadol and Fluoxetine Interaction appeared first on Med Ed 101.

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