Fri.Oct 04, 2024

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FDA Roundup: Biosimilar Approval, Hereditary Angioedema Treatment Receives Orphan Drug Designation

Drug Topics

Check out important updates from the FDA for the week of September 30.

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Rwanda to receive experimental vaccines, therapeutics to combat Marburg outbreak

STAT

Experimental vaccines and therapeutics to combat the deadly Marburg virus will begin arriving this weekend in Rwanda, where they will be used in clinical trials expected to begin soon, a U.S. government official confirmed on Friday. There are currently no licensed vaccines or drugs to prevent or treat Marburg, a cousin of the Ebola family of viruses that transmits and causes illness in the same way as Ebola.

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Trending Sources

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Beyond Blood Glucose: Addressing Adolescent Diabetes Challenges

Drug Topics

Social pressures, physiological changes, mental health challenges, and burnout all complicate diabetes management among adolescents.

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Cologuard Plus Receives FDA Approval For Non-Invasive Colorectal Cancer Screening

Pharmacy Times

The new screening test provides an easier, convenient option for patients seeking to screen themselves for colorectal cancer.

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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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STAT+: Q&A: AI is coming for lots of jobs. What about that of the cancer researcher?

STAT

Sam Altman, co-founder of OpenAI and co-creator of ChatGPT,  keeps saying artificial intelligence will help cure cancer. Altman’s going further these days, envisioning a future where an AI essentially replaces the principal investigator. In a discussion last month that was widely circulated this week on social media, Altman recounted chatting with a cancer researcher about a time when an AI would issue experimental plans and tasks to human scientists to complete.

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FDA Grants Orphan Drug Designation to LQT-1213 to Treat Patients With Long QT Syndrome

Pharmacy Times

The treatment aims to reduce prolonged QTc interval in patients with long QT syndrome.

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More Trending

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Children Conceived Through IVF Are More Likely to Develop Congenital Heart Defects

Pharmacy Times

Research showed that children born via assisted reproductive technology were 36% more likely to develop heart defects.

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STAT+: Medicare Advantage market expected to grow in 2025, despite big changes from insurers

STAT

Next year’s Medicare Advantage market will be two things at once: remarkably stable broadly, but rife with changes under the surface. Health insurance companies will still offer older adults a lot of plan choices with low, or completely free, premiums. That’s why the federal government expects enrollment in the $500 billion Medicare Advantage program to grow once again in 2025 — a stark contrast from insurers’ cries that modest payment reforms would damage them and se

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FDA Approves Nivolumab for the Treatment of Adult Patients With Resectable NSCLC

Pharmacy Times

Nivolumab is the only PD-1 inhibitor to show statistically significant and clinically meaningful benefits in non-small cell lung cancer compared with chemotherapy.

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Opinion: It’s time for a new medical specialty in asynchronous care

STAT

As primary care physicians, we see a scene play out almost daily. A patient is sitting in front of us, explaining her symptoms: She could have difficulty breathing, stress at home, fatigue. We know there is nothing more important than being fully present. However, our minds and eyes keep darting to the computer screen and the growing inbox of messages from other patients: “I forgot my Lipitor for a week, should I double up tomorrow?

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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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New CDC Data Show Decrease in Vaccine Coverage Among Kindergarteners For 2023-2024 School Year

Pharmacy Times

Significant polarization surrounding COVID-19 vaccinations in late 2020 and early 2021 looked to have had an impact in increasing vaccine hesitancy.

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STAT+: Exact Sciences wins FDA approval for improved stool-based colon cancer test

STAT

Exact Sciences won Food and Drug Administration approval on Friday for an improved version of a stool-based screening test for colon cancer that should result in fewer cancer-free patients receiving unnecessary follow-up colonoscopies. The FDA approved the test, Cologuard Plus, for adults 45 and up with an average risk of cancer based on results from a large clinical trial, dubbed Blue-C, which recruited more than 20,000 participants.

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Plozasiran May Help Reduce Cholesterol Levels in Patients with Mixed Hyperlipidemia

Pharmacy Times

High cholesterol levels are known risk factors for atherosclerotic cardiovascular disease.

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US' top IV fluid maker Baxter voices uncertainty about recovery timeline at NC facility hit by Helene

Fierce Pharma

After announcing the closure of its biggest manufacturing site Sunday due to flooding caused by Hurricane Helene, Baxter International—the U.S.’ top supplier of hospital IV fluids—is laying out det | While progress is already being made after Hurricane Helene, which resulted in water “permeating” Baxter’s large IV fluid production plant in North Carolina, the company cautioned that it does not yet have a timeline for when operations will be back online.

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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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After a rocky debut for new RSV tools, hopes are high as a new season approaches

STAT

Georgina Peacock vividly remembers a night when she admitted 20 babies, all struggling to breathe, into the hospital where she was doing her pediatric medical training. The illness that was robbing them of breath? Respiratory syncytial virus, or RSV. Peacock and many others who are responsible for the care of the country’s youngest children have been moving heaven and earth for the past year and a bit, to make experiences like that a thing of the past.

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An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped?

PharmaVoice

Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.

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Hospitalized COVID-19 Patients Face Worsened Long-Term Cognitive Function

Pharmacy Times

Major biomarkers for cognitive impairment were observed in hospitalized patients with neurological symptoms.

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FDA Approves New Non-Invasive Colorectal Cancer Screening Test

Drug Topics

Cologuard Plus is approved for adults aged 45 years and older who are at average risk for the disease.

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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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What Is RSV?

Pharmacy Times

Carrie Koenigsfeld, PharmD, FAPhA, discusses an overview of RSV, including its transmission, incidence, seasonality, and clinical presentation.

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Multimodal Approach Suggested for Treating Pain Amongst Adolescents

Drug Topics

Researchers aimed to determine whether or not opioids were appropriate for treating adolescents experiencing chronic pain.

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Adam’s 3 Years as an NF2 BioSolutions PhD Student

NF2 BioSolutions

Hello everyone, For the last 3 years, I have been a NF2 BioSolutions-funded PhD student working within Manchester alongside Grace Gregory, and it has been such a rewarding and positive experience, not only for my personal development, but for driving forward our understanding of NF2 -related Schwannomatosis ( NF2 SWN) and potential new treatments. Alas, my PhD has finally come to an end, but I’m please to share with you some of the key findings from my work that will hopefully change the ways in

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FDA approval give BMS an edge in NSCLC treatment

pharmaphorum

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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In sustained rare disease push, Recordati lays out $825M upfront to acquire Sanofi's CAD drug Enjaymo

Fierce Pharma

As Sanofi continues to clean out its medicine chest, Italy’s Recordati is getting in on the action. | Recordati is floating $825 million upfront—plus another $250 million in potential commercial milestones—to get its hands on the global rights to Sanofi’s rare disease biologic Enjaymo. In 2022, Enjaymo became the first and only therapy specifically approved by the FDA for treating patients with the uncommon blood disorder cold agglutinin disease.

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Mounjaro and Zepbound shortages over, declares FDA

pharmaphorum

FDA declares an end to tirzepatide shortage, the active ingredient in Eli Lilly’s popular weight loss medication Zepbound and diabetes drug Mounjaro.

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STAT+: Pharmalittle: We’re reading about an Italian acquisition, Medicare Advantage market growth, and more

STAT

A pleasant Friday morning to you! Adam Feuerstein, here, reporting from the Pharmalittle campus, temporarily relocated to Cambridge, Mass., as your regular New Jersey host Ed takes the day off. Like the one-and-only Mr. Pharmalot, I enjoy my daily headlines with a hot cup of joe. Have a great weekend.  Italian pharma company Recordati said it will buy from Sanofi the global rights to an approved drug to treat cold agglutinin disease , a rare autoimmune disorder, for $825 million, Reuters re

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Hospitals' August margins stay level despite high volumes, shorter length of stay

Fierce Healthcare

Though their margins have largely remained level, hospitals are starting to get a handle on length of stay and per-patient expense growth as demand for inpatient care remains strong, according to A | Kaufman Hall's monthly index report showed continued demand and more efficient inpatient care, but muted revenue gains. A concurrent report on third quarter M&A also outlined a spike in dealmaking.

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WuXi looks to sell assets as BIOSECURE Act looms

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Hello, hello. Today we talk about whether the AI overlords will commandeer cancer research (on top of everything else in this world), WuXi is looking to sell some of its operations, ostensibly because of the BIOSECURE Act, and more.

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Grace’s 3 Years as an NF2 BioSolutions UK PhD Student

NF2 BioSolutions

Hi everyone! What a journey it has been over the last 3 years, being one of the first two NF2 BioSolutions UK and Europe PhD students alongside Adam! I have enjoyed every moment, and I have made the most of all the opportunities to pass my way through the University of Manchester, NF2 research community and the Charity, all of whom have driven this research forward.

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CMS proposes risk adjustment changes, broker fraud crackdown for 2026 plan year

Fierce Healthcare

A proposed rule from the Centers for Medicare & Medicaid Services (CMS) released Oct. | CMS is looking to shake up the risk adjustment model and wants the ability to suspend shady brokers from the insurance marketplace, the agency wrote among other updates in a new proposed rule.

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Can you drink while taking fluconazole?

The Checkup by Singlecare

You open the medicine cabinet to take a dose of fluconazole prescribed to tackle a stubborn yeast infection. Later, as you meet friends for dinner, you wonder whether it’s safe to enjoy a glass of wine. Fluconazole , also sold under the brand name Diflucan , is a commonly used antifungal medication, but generally, it’s not recommended to drink while taking it.

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Eye of the Beholder: Understanding The Subjective Experience of Acute Ketamine Treatment

Pharmacy Times

When considering the 3-stage framework, perhaps a greater emphasis on pre-treatment phase research could help identify some of the more individual traits used to better predict patient outcomes.

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Morning Rounds: Hurricane Helene’s impact on health care; Vance on health insurance

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Today’s item on bacterial outbreaks linked to hospital ice machines reminded me of The National’s song “Ice Machines,” so pardon me for slipping into music recommendation mode for a second.

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Does Wegovy help with insulin resistance?

The Checkup by Singlecare

Many people struggle with managing blood sugar levels and dealing with excess weight. If you’re in this situation, you might feel frustrated and worried about developing Type 2 diabetes. This double burden isn’t just exhausting; it may also be harmful to your health. A healthcare provider might suggest a medication like Wegovy (semaglutide) to manage these problems.

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