Fri.Sep 06, 2024

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FDA Roundup: Novavax COVID-19 Vaccine, First Digital Therapeutic for GAD

Drug Topics

Check out important updates from the FDA for the week of September 2.

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Missouri resident who had no contact with animals tests positive for bird flu

STAT

This is a developing story and will be updated. A person in Missouri who didn’t report any contact with animals has tested positive for H5 bird flu, the state’s Department of Health and Senior Services and the Centers for Disease Control and Prevention said Friday. It’s not yet clear if the person was infected with the same virus strain that’s causing the ongoing outbreak among dairy cattle.

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Trending Sources

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Abbott’s OTC Lingo CGM for Wellness Now Available

Drug Topics

Lingo offers users a real-time glucose graph, a metric to track glucose spikes, food and activity logging, personal recommendations, and challenges to motivate healthy behaviors.

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FDA Approves Sparsentan, With Data Indicating Slowing of Kidney Function Decline in IgA Nephropathy

Pharmacy Times

Full traditional approval follows accelerated approval of the medication last year.

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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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Community Pharmacist-Led Intervention for Victims of Domestic Abuse, Suicidal Ideation

Drug Topics

Researchers analyzed a co-developed pharmacy-based intervention for individuals who have experienced domestic abuse or suicidal ideation.

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Study: Shingles Could Increase Risk of Cognitive Decline

Pharmacy Times

Individuals with a history of shingles was significantly and independently connected with a 20% higher risk of for subjective cognitive decline.

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More Trending

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American Medical Association slams pay cut, G-codes in proposed Medicare pay rule for doctors

Fierce Healthcare

In its comments to the Centers for Medicare and Medicaid Services (CMS) on the draft CY2025 Medicare physician fee schedule (PFS), the American Medical Association badgered CMS on its pro | The American Medical Association submitted its comment letter to CMS on its draft CY2025 Medicare physician fee schedule. At issue was the 2.

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Navigating Multiple Myeloma Care: Balancing CAR T-Cell Therapy and Immunotherapy

Pharmacy Times

The evolving treatment landscape for multiple myeloma includes debates on the timing and effectiveness of CAR T-cell therapy and quadruple immunotherapy regimens.

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STAT+: Ascension, other hospitals played active roles to take medical billing company R1 RCM private

STAT

Private equity firms are leading the buyout of R1 RCM , a major provider of billing and administrative services for hospitals and physician groups. But R1’s hospital customers — some of the biggest systems in the country — were influential in steering the company to that outcome. Ascension, a nonprofit Catholic health system, is R1’s largest client and biggest shareholder through an investment fund with private equity firm TowerBrook Capital Partners.

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What to Expect As New CMS Hospital Transparency Requirements Take Effect in 2025

Pharmacy Times

New transparency initiatives will go into effect on January 1, 2025, building off previous actions by the Centers of Medicare and Medicaid Services.

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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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Providers, vendors building health AI have 'shared responsibility' to ensure safe adoption industrywide

Fierce Healthcare

BOSTON—There’s no shortage of providers and vendors working to develop and deploy artificial intelligence in healthcare—but not all who are delivering care are in a position to make use of these no | Healthcare AI has a tough battle on adoption, trust and responsible use, particularly among organizations lacking in-house tech expertise. Whether it's a vendor or another health system, stakeholders must be prepared to help their peers along the way, experts say.

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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.

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Thatch secures $38M, backed by a16z and General Catalyst, to expand ICHRA benefits

Fierce Healthcare

Thatch wants to turn the traditional approach to health insurance on its head. | Thatch wants to turn the traditional approach to health insurance on its head. The company secured $38 million, backed by a16z and General Catalyst, to scale up its technology and fuel its growth.

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Obesity, Emaciated BMI Associated With Poor Prognosis in Pediatric B-Cell Non-Hodgkin Lymphoma

Pharmacy Times

Surprisingly, those with overweight BMI at diagnosis did not have a poor prognosis.

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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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Election results shouldn't upend hospitals' exchange volumes, Medicaid supplements, execs say

Fierce Healthcare

As the country gears up for November elections, health systems say they are keeping an eye on, but not severely concerned about, potential major changes in the Affordable Care Act exchanges or Medi | Regardless of who takes charge in Washington, the heads of America's largest for-profit health systems are downplaying the likelihood of major political interference in populations and programs that have become increasingly important to their bottom lines.

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GSK posts COPD win for Nucala as Sanofi-Regeneron rival Dupixent nears delayed FDA decision

Fierce Pharma

GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. | On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.

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Expert: Travel Vaccines Should Be Personalized Based on the Destination

Pharmacy Times

A pharmacist with Allegheny Health Network discusses travel vaccines and what resources are valuable when determining which vaccinations are needed prior to travel.

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Gilead's Trodelvy triplet underwhelms, but bolsters company's phase 3 lung cancer design: exec

Fierce Pharma

Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. | Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. But it looks like that win won’t come from a triplet regimen that combines the antibody-drug conjugate with Merck’s Keytruda and chemotherapy in newly diagnosed non-small cell lung cancer.

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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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RSV Vaccination Could Decrease Hospitalization Among Adults 60 Years and Older

Pharmacy Times

RSV vaccination was 75% effective in preventing RSV-associated hospitalizations among adults aged 60 years and older.

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FDA Approves Nymalize in Prefilled ENFit Syringes

Drug Topics

Nymalize is an effective alternative to capsule extraction for adult patients with subarachnoid hemorrhage who are unable to swallow capsules.

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FDA Grants Breakthrough Therapy Designation to Sanbexin for Acute Ischemic Stroke

Pharmacy Times

Edaravone and dexborneol sublingual tablets are an innovative first drug to be designed for treatment of stroke and granted this designation.

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Transparent mice and using zip codes to predict heart risk

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Hello! Timmy here. I will be spending ten hours on Sunday carrying my wonderfully chaotic niece on my shoulders while she points at mascots at Kings Island amusement park. Please pray for my shoulders!

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Mississippi Medicaid awarding contracts to Centene, Molina, TrueCare after 2-year delay

Fierce Healthcare

Two years after Mississippi awarded Medicaid contracts to three insurers, the state is finally moving forward with its decision following challenges from UnitedHealthcare and Elevance Health. | Protests from UnitedHealth and Elevance Health, which have delayed implementation of Mississippi's Medicaid awards, are so far proving unsuccessful.

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BioAge's $100m IPO, and other biotech financings

pharmaphorum

Financings in the biotech sector this week include an IPO filing for BioAge and private rounds for eGenesis, Navigator, and Circle Pharma.

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Can you drink while taking Zyrtec?

The Checkup by Singlecare

You took your morning Zyrtec dose to manage pesky allergy symptoms, only to remember you’re supposed to go wine tasting later. This situation raises an important question: can you safely mix Zyrtec and alcohol without adverse effects? It’s a common scenario for many and worth exploring how allergy medications and alcohol interact. Generally, mixing Zyrtec and alcohol is not recommended without a healthcare provider’s guidance.

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GSK says Nucala hits the target in new COPD trial

pharmaphorum

GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial.

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STAT+: Pharmalittle: We’re reading about FDA inspections, Lilly insulin trial results, and more

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up. As always, we plan to promenade with the official mascots and catch up on our reading, although we also expect to entertain a traveler. On that note, we are planning another listening party, where the rotation will likely include this , this , this , this , and this.

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Lykos CEO steps down after MDMA is rejected by FDA

pharmaphorum

The fallout from the FDA's recent decision not to approve Lykos Therapeutics' psychedelic treatment has spread to its senior management, with chief executive Amy Emerson stepping down.

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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 adds to genetic meds push with Genetic Leap alliance

pharmaphorum

Eli Lilly signs another genetic medicines deal, this time with Genetic Leap, a start-up that applies AI to the discovery of RNA-targeted drugs.

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A Total View of Central Fulfillment Strategies

Drug Topics

Transform your pharmacy operations with centralized fulfillment. This whitepaper reveals how advanced automation can help you manage rising prescription volumes and workforce challenges. Learn how leading pharmacies optimize efficiency and reduce costs with proprietary software and automated robotic solutions. Download now and discover the future of pharmacy fulfillment.

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Embracing diversity in psychiatry and neurology clinical trials

pharmaphorum

Embracing diversity in psychiatry and neurology clinical trials is crucial for ensuring that treatments are effective for all populations. Learn about the importance of diversity in clinical trials and how to promote inclusivity in research.

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FDA approves Amneal and Shilpa’s oncology product BORUZU

Pharmaceutical Technology

The US FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration.

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