Thu.Oct 24, 2024

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FDA Recalls Over 7000 Bottles of Duloxetine Because of Chemical Presence

Pharmacy Times

The FDA announces a Class II recall for the lot #220128, which were reported to contain the presence of nitrosamine.

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Opinion: ‘Do no harm’ is hurting 400 million long Covid patients worldwide

STAT

Imagine, for a moment, that you wake up one morning with a debilitating illness that won’t let go. Weeks and months pass, but the crushing fatigue, constant headaches, and aching muscles remain. You can’t think straight. Simply showering or doing the dishes leaves you floored for days at a time, and the unpredictable symptoms — shortness of breath, dizziness, a racing heart — ebb and flow without warning.

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ACIP Lowers Pneumococcal Vaccination Recommendation to Age 50

Pharmacy Times

The CDC Advisory Committee on Immunization Practice voted to expand the recommendation, which includes Prevnar 20 and Capvaxive.

Vaccines 149
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STAT+: UnitedHealth was top insurer collecting billions in questionable Medicare payments, federal watchdog finds

STAT

A federal watchdog found that Medicare Advantage insurers collected billions of dollars in dubious payments from Medicare in a single year by using home visits and medical chart reviews to diagnose patients with conditions for which they received no follow-up care.    A report released Thursday by the Office of Inspector General for the Health and Human Services Department concluded that insurers collectively received an estimated $7.5 billion in payments last year from so-called

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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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Shaping the Future of Pharmacogenomics: STRIPE Drives Stakeholder Consensus at Inaugural Meeting

Pharmacy Times

Benjamin Brown of Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) discusses his own experience as a patient with cancer and how consensus around pharmacogenomic practices can improve the lives of patients.

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Drinking is cheaper than it’s been in decades. Lobbyists are fighting to keep it that way

STAT

For years, it has been a reliable way to cut back on the consumption of cigarettes and sugary drinks: raise taxes on them. So it might seem an obvious tactic to apply to alcohol, which contributes to untold injuries, diseases and deaths in the United States each year. That’s the thinking of advocates and state legislators across the country, who also see it as a way to pull in more revenue.

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STAT+: Ozempic linked to lower risk of Alzheimer’s diagnosis in observational study

STAT

Novo Nordisk’s drug Ozempic was linked to a lower risk of getting diagnosed with Alzheimer’s among people with type 2 diabetes, an analysis of medical records found, supporting the case for further research of the blockbuster GLP-1 drug in neurodegenerative diseases. Among the over 1 million people with diabetes whose records were included in the study, the overall risk of developing Alzheimer’s was already very low.

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Extended Antiviral Treatment Could Benefit Ocular Shingles Vision Outcomes

Pharmacy Times

Treatment with valacyclovir for a year decreased the risk of new or worsening eye disease by 26%.

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Dyania Health pockets $10M to automate patient chart review with AI

Fierce Healthcare

Dyania Health is using artificial intelligence to automate manual patient chart review, boosting providers' ability to comb through medical records and speeding up medical research. | Dyania Health is using artificial intelligence to automate manual patient chart review, boosting providers' ability to comb through medical records and speeding up medical research.

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STAT+: Q&A: At Flagship’s London outpost, an executive sees scientific potential ready to ‘unlock’

STAT

LONDON — A coworking space surrounded by the crush of traffic around King’s Cross station is perhaps not the most glamorous digs. But as the site of Flagship Pioneering’s U.K. outpost, it fits. Not far are University College London, the Wellcome Trust, and the Francis Crick Institute. Novo Nordisk and Merck have major hubs nearby, as do Meta and Google.

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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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AMA leads new antitrust lawsuit against MultiPlan and price-fixing cartel

Fierce Healthcare

MultiPlan destroys market competition and engages in price-fixing with major insurers, a lawsuit from the American Medical Association (AMA) and the Illinois State Medical Society alleges.

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CDC testing suggests Missouri did not see a cluster of bird flu cases

STAT

Blood testing conducted by the Centers for Disease Control and Prevention has confirmed that one person in Missouri with no known exposure to cattle or poultry contracted H5N1 bird flu in August, and a household contact of the individual may also have been infected. But five health workers who went on to develop influenza-like symptoms after caring for the confirmed case were not infected with the virus.

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UK launches scheme to boost dementia trial participation

pharmaphorum

UK scheme to tackle "historically low" numbers of people taking part in dementia trials launches with £20m in government funding

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STAT+: Gilead needs a win with Arcellx CAR-T data. Here’s how to know if it scores

STAT

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. The next referendum on Gilead Sciences’ oft-criticized oncology business is approaching. Circle Nov. 5 on your calendars. That’s when we’ll get the first look at data from a pivotal clinical trial of anito-cel, the personalized, BCMA-directed CAR-T therapy for multiple myeloma being developed under a pa

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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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GSK answers Pfizer's RSV approval with data targeting matching nod in younger adults

Fierce Pharma

Results from two phase 3 trials show that GSK’s RSV vaccine Arexvy excelled in a broad age range of immunocompromised and other at-risk patients.

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STAT+: General Catalyst raises $8 billion fund with $750 million for health care bets

STAT

The venture capital giant General Catalyst has raised an $8 billion fund with $750 million set aside for health care investments as its acquisition of an Ohio safety net hospital undergoes regulatory review. Fund XII consists of $4.5 billion for funds dedicated to seed and growth equity, $1.5 billion for creating new companies, and $2 billion of “separately managed accounts,” the firm said.

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Molina Healthcare stock soars after beating Q3 earnings

Fierce Healthcare

California-based Molina Healthcare is seeing its stock rise dramatically after the company easily beat third quarter earnings expectations Oct. 24. | Molina Healthcare posted an adjusted earnings per share of $6.01 and $10.34 billion in total revenue.

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Pfizer’s activist troubles, gene therapy questions, RFK Jr.’s MAHA ambitions

STAT

Will an activist investor campaign against Pfizer lead to big changes at the struggling Pharma giant? Why are some experts questioning the regulatory standards used to approve gene therapies for Duchenne muscular dystrophy? What’s the difference between Novo Holdings and Novo Nordisk, and will it impact a $16 billion acquisition of Catalent? And what lies ahead for Robert F.

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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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Marinus to trim workforce, weigh 'strategic alternatives' after another Ztalmy trial miss sends shares tumbling

Fierce Pharma

It’s déjà vu for Marnius Pharmaceuticals. | The recent trial flop for Ztalmy, this time in tuberous sclerosis complex (TSC)-associated seizures, leaves the company in a cost-cutting scramble as it moves to explore "strategic alternatives.

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STAT+: Study on Sarepta Therapeutics’ Duchenne therapy diverges from the company line

STAT

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. The EMBARK Phase 3 study for Elevidys, Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy,  was published this month  in Nature Medicine. The paper largely reiterates what’s already known about the negative study — Elevidys failed to achieve its primary endpoint of improving ov

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Walmart to Deliver Prescriptions in 49 States by 2025

Drug Topics

Adding to the mail-order options within big chain pharmacy, Walmart is promising prescription delivery in as quickly as 30 minutes.

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Health AI startups: How long do they take to hit $10 million in sales

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Are health AI businesses zooming? In a new report , Bessemer Venture Partners unpacks early insights about the prospects for artificial intelligence software services businesses it sees as a new category in the broader health tech ecosystem.

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WhatsApp lands Moderna in hot water with PMCPA

pharmaphorum

WhatsApp message earns Moderna a reprimand under the ABPI Code, with Novo Nordisk, Otsuka, AstraZeneca and Daiichi Sankyo also breaching the rules

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Opinion: STAT+: Four leading biopharma executives weigh the 2024 election

STAT

As Election Day 2024 gets closer, STAT’s First Opinion asked executives from leading biotech and pharmaceutical companies to reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration. Read an excerpt from each below. “ What Sandoz CEO Richard Saynor is thinking about the 2024 elections ” With all eyes currently on the upcoming U.S. elections, it’s easy to forget that this

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Legal win leads Amgen to at-risk launch of Eylea biosimilar

pharmaphorum

Legal win leads Amgen to at-risk launch of Eylea biosimilar Phil.

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STAT+: Pharmalittle: We’re reading about drug shortages, what drugmakers didn’t tell Alzheimer’s trial patients and more

STAT

Rise and shine, everyone, another busy day is on the way. We can tell because the pace of motor vehicles passing by our window is picking up and the official mascots are busy foraging for their breakfast on the campus grounds. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is maple bourbon. Yes, this is for real.

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Hyntelo: AI solutions for improved customer engagement

pharmaphorum

Hyntelo offers cutting-edge AI solutions like GenAI for enhanced customer engagement. Learn how Hyntelo integrates as a Veeva AI Partner.

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The war against alcohol taxes

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! If you aren’t already subscribed to DC Diagnosis , the newsletter from our amazing reporters down in DC, what are you doing? Have some coffee Pharmalot -style, then get on that.

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Lundbeck planning for four novel drugs in phase 3 in 2026

pharmaphorum

Denmark's Lundbeck has said that efforts to build its R&D portfolio are on track to deliver four new molecular entities (NMEs) in phase 3 trials in 2026, including an epilepsy drug from its recently announced $2.6 billion takeover of Longboard Pharma.

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Navigating IV Fluid Shortages Post-Hurricane Helene: Insights From USP on Compounding and Conservation Strategies

Pharmacy Times

Damage to a Baxter manufacturing plant in the aftermath of Hurricane Helene has led to significant IV fluid shortages throughout the country.

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Psychiatric Pharmacist Helping to Bridge the Care Gap for Patients With Mental Illness

Drug Topics

Nina Vadiei, PharmD, BCPP, a clinical associate professor at UT Austin and a clinical pharmacy specialist in psychiatry at San Antonio State Hospital, discusses her career as a psychiatric pharmacist.

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Pharmacist Highlights the Impact of Integrated Care and NCODA’s PQIs on Patient Access

Pharmacy Times

Stephanie White, PharmD, CSP, is presenting at the NCODA Fall Summit in Orlando, Florida.

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Addressing the Burden of Flare-Ups in Atopic Dermatitis | AMCP Nexus 2024

Drug Topics

Research presented at AMCP Nexus 2024 underscored and explored the need for treatments that can prevent or mitigate flare-ups in patients with AD.

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