Mon.Sep 23, 2024

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Q&A: How Cebranopadol Could Help Address Gaps in Pain Management

Drug Topics

Albert Dahan, MD, PhD, discusses how cebranopadol could fit into the broader landscape of pain management therapies.

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STAT+: Electronic health records giant Epic Systems sued over alleged monopolistic practices

STAT

The health data company Particle Health has filed an antitrust lawsuit against Epic Systems, alleging that the electronic health record vendor has used its control of patient data to thwart competition and undermine its business. The suit filed Monday in federal court in the Southern District of New York is a full-throated assault on Epic’s dominance in the market for electronic health records, charging that the privately held company has become a “behemoth” and a “mo

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Startup Particle Health files antitrust lawsuit against Epic alleging it uses monopoly power to block competition

Fierce Healthcare

What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations. | Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records giant is trying to muscle out competition in the payer platform market.

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STAT+: A mysterious anti ‘Big Pharma’ bus is barnstorming swing states

STAT

WASHINGTON — The wheels on a big red bus emblazoned with anti-pharmaceutical industry messaging are going ’round and ’round all through the nation’s electoral battlegrounds, from Montana to Arizona to Pennsylvania. But nobody will say who’s paying to fill up the gas tank. A new dark-money group called Americans for Pharma Reform has launched a multi-state bus tour to bring awareness to what they characterize as bad behavior by the pharmaceutical industry.

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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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FDA Grants Bimekizumab-Bkzx Approval for Treatment of Chronic Immune-Mediated Inflammatory Diseases

Pharmacy Times

Approved with 3 new indications, bimekizumab-bkzx is the first and only interleukin-17 inhibitor approved for these diseases.

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STAT+: Millions of Americans want to quit smoking. Critics say drugmakers and the FDA are failing them

STAT

WASHINGTON — Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. It’s a jarring statistic — and an indictment of the treatment options for an addiction that kills 480,000 people in the U.S. each year. The smoking-cessation drugs on the market don’t work well for the majority of people, and they come with side effects and reputations that keep some smokers from ever trying them.

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Opinion: 40 doesn’t look good on Hatch-Waxman

STAT

As the Hatch-Waxman Act approaches its 40th anniversary, it’s time to critically examine its legacy and what it actually gave us: the  highest drug prices in the world. One of the main objectives of the Hatch-Waxman Act was to bring more generic drugs into the market. If viewed through that lens only, the act has been an overwhelming success.

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PQA to Host Forum on Quality Medication Use in Rare Disease

Pharmacy Times

Event will share patient, specialty pharmacy, pharmaceutical industry and payer perspectives

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Opinion: New HHS rules can’t address the primary reason for research misconduct

STAT

On Tuesday, the Department of Health and Human Services published new policies  on research misconduct , which apply to research institutions receiving funding through the U.S. Public Health Service. The policies set standards that institutions must follow when investigating and potentially sanctioning researchers alleged to have engaged in research misconduct.

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UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals

Fierce Pharma

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

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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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STAT+: Wegovy is among drugs set to be targeted in the next round of Medicare price negotiations, researchers say

STAT

The GLP-1 drug Wegovy tops the list of medications expected to be included in the next round of Medicare price negotiations, according to a paper in the Journal of Managed Care & Specialty Pharmacy.  Last month, Medicare officials unveiled prices for the first 10 drugs chosen for negotiation. Now, all eyes are on which Part D drugs will be chosen for the next round of 15 drugs.

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The Community Pharmacist’s Role in the Management of Migraine

Pharmacy Times

Migraine is a chronic neurological disease characterized by throbbing or pulsating unilateral or bilateral headache that can last from hours to days.

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STAT+: Risky bet by Biogen and UCB on systemic lupus drug appears to pay off, data show

STAT

Biogen and UCB said Tuesday that an experimental drug reduced disease activity and symptoms of systemic lupus, achieving the primary goal of a placebo-controlled Phase 3 study.  Detailed study results were not included in the press release issued by the companies, so how much participants benefited from the drug, called dapirolizumab pegol, won’t be known until data are presented at a medical meeting.

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J&J hopes 3rd time's the charm for Texas two-step strategy as it lifts talc settlement offer to $8B

Fierce Pharma

Despite being thrown off its rhythm twice already, Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the compan | Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the company’s talc products caused users to develop cancer.

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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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STAT+: As Medicare spending on remote patient monitoring jumps, HHS watchdog warns of fraud, misuse

STAT

The federal watchdog at the Department of Health and Human Services issued a report on Tuesday calling for more oversight of remote patient monitoring in Medicare. The Office of Inspector General’s report called out the potential for fraud and misuse of tools like at-home blood pressure cuffs, connected scales, and continuous glucose monitors that can feed data directly to a patient’s doctor.

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FDA clears first drug for Niemann-Pick disease

pharmaphorum

Zevra Therapeutics' Miplyffa is first drug approved by the FDA for ultra-rare disease Niemann-Pick type C.

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Monday mysteries: An anti-pharma bus and Missouri bird flu updates

STAT

Good morning! Health care challenges like anti-microbial resistance have long created narrative tension for shows like Grey’s Anatomy. But what about an entire musical about it? Ask and ye shall receive. The wheels on the anti-pharma bus … echo GOP talking points A new, dark money group called Americans for Pharma Reform is aiming to bring awareness to what they call bad behavior by the pharmaceutical industry.

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FDA Approves Bimekizumab-Bkzx for Psoriatic Arthritis, 2 Other Indications

Drug Topics

The monoclonal antibody was also approved for active non-radiographic axial spondyloarthritis and active ankylosing spondylitis.

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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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Appeals Court resurrects PhRMA's lawsuit challenging pricing provisions in IRA

Fierce Pharma

For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet. | Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February, punting the complaint back to a lower Texas court.

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FDA Accepts NDA for Delgocitinib Cream to Treat Chronic Hand Eczema

Drug Topics

LEO Pharma expects the regulatory review process to be completed in the second half of 2025.

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FDA clears RHYTHM AI's new algorithm for atrial fibrillation

pharmaphorum

RHYTHM AI has FDA approval for a new version of its algorithm for mapping areas of the heart that are affected by atrial fibrillation

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FDA, CDC: E-Cigarette Use Among Youth Continues to Plummet

Drug Topics

Initiatives such as media campaigns and legislative rulings by the agencies have likely contributed to the decline.

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The biotech news you need to start the week

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Today, we discuss a bus with anti-pharma messaging that’s traversing the country, we see the FTC file a suit against the three biggest pharmaceutical benefit managers, and more.

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FDA Accepts New Drug Application for Delgocitinib Cream to Treat Chronic Hand Eczema

Pharmacy Times

If approved, delgocitinib cream would be the first US treatment indicated for moderate to severe chronic hand eczema.

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FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

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Legend Biotech inks deal for 'priority access' to Multiply Labs' robotic cell therapy production tech

Fierce Pharma

After several years spent honing its robotic cell therapy manufacturing system, Multiply Labs has snared its first collaboration with a major cell therapy developer. | After several years spent building partnerships to hone its robotic cell therapy manufacturing system, Multiply Labs has snared its first collaboration with a major cell therapy developer: Legend Biotech.

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STAT+: Pharmalittle: We’re reading about a ‘Bust Big Pharma’ bus tour, few smoking-cessation drugs, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because — you guessed it — that oh-so familiar routine of online meetings, annoying commutes, and deadlines has predictably returned. But what can you do? The world, such as it is, somehow continues to spin no matter how hard we try to slow it down.

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Why UnitedHealthcare is putting a focus on simplicity in its AI strategy

Fierce Healthcare

It's not a secret that navigating the healthcare system is complicated, and the UnitedHealthcare team has rolled out a tool backed by artificial intelligence that aims to make it easier for members | It's not a secret that navigating the healthcare system is complicated, and the UnitedHealthcare team has rolled out a tool backed by artificial intelligence that aims to make it easier for members to shop around.

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STAT+: Will prescription drugs get prior authorization reform?

STAT

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine.  Sign up  to get it in your inbox every Monday. FTC v. the Big 3 Kevin Dietsch/Getty Images The animosity between the Federal Trade Commission and pharmacy benefit managers has reached a boiling point. The FTC sued the nation’s three biggest PBMs last week, accusing them and their secretive group purchasing organizations of creating a “perver

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CEEVs, Neurovascular Coupling, and Functional Connectivity Are Potential Markers For Mild Cognitive Impairment

Pharmacy Times

The authors note this is the first study to assess cerebrovascular endothelial extracellular vesicles within a cognitive condition.

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Keeping the Focus on Community Pharmacy Advocacy at the State Level

Drug Topics

Drug Topics discussed independent pharmacy advocacy and PBM reform on the state level with Miguel Rodriguez, Executive Vice President and general counsel for American Pharmacies.

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Study Finds Measles-Rubella Disease Surveillance System Lacks Networking, Partnerships, and Community Involvement

Pharmacy Times

A 95% increase in private health center participation, monitoring, assessment, and vaccine coverage can be significant in improving outcomes.

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Leading Artificial Intelligence (AI) Companies in Pharma

Pharmaceutical Technology

View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.

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