Fri.Sep 27, 2024

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Schizophrenia Drug Approved by FDA Represents First New Treatment Option in Decades

Drug Topics

The approval of xanomeline and trospium chloride (Cobenfy) from Bristol Myers Squibb represents a “transformative moment in the treatment of schizophrenia.

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Four more health care workers reported illnesses after caring for bird flu case in Missouri

STAT

An investigation into the still unexplained human H5N1 bird flu infection in Missouri has turned up four additional health care workers who developed mild respiratory illness symptoms after caring for the patient in hospital in August, the Centers for Disease Control and Prevention reported on Friday. It is not clear if any of these people were actually infected with H5N1; they were not tested at the time when they were ill.

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FDA Approves Dupixent as First Biologic Treatment for COPD

Drug Topics

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways.

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Opinion: Sequencing wastewater material may be the key to getting a grip on the H5N1 bird flu outbreak

STAT

Despite no known infections of H5N1 bird flu among its dairy cows, Missouri recently detected a case in a person with no apparent exposure to possibly infected animals or related products (i.e., raw milk). A close contact and two health workers who cared for the person all developed respiratory symptoms , but were never tested. There has not yet been a wider uptick of other potential cases in the same community to indicate efficient human-to-human transmission — the evolution of which is

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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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Senate Committee Hearing Examines the High Cost of Pharmaceutical Innovation

Drug Topics

Without financial incentives, some senators expressed concerns that pharmaceutical research and development would stall.

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FDA Approves Dupilumab as Add-On Maintenance Therapy For Adults With COPD

Pharmacy Times

Dupilumab is the first biologic medicine for patients with chronic obstructive pulmonary disease to be approved in the US.

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FDA Approves Cobenfy, Previously KarXT, for Treatment of Schizophrenia

Pharmacy Times

Xanomeline and trospium chloride is the first in a new class, offering a new approach with selectively targeting M 1 and M 2 receptors.

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Sickle cell community scrambles to find safe plan after a drug is pulled from the market

STAT

She knew what it was to have pain she couldn’t put into words, but this was worse. As a child, Nana-Bilkisu Habib had felt it in her arms or legs or back, but this was everywhere, as if her whole body were shutting down. She couldn’t move. Her dad had to carry her into the car and lay her in the backseat. She spent the drive to the hospital reciting verses of the Quran, praying that she would make it through.

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Healthcare conferences to put on your calendar for 2024-2025

Fierce Healthcare

Looking for healthcare events in the fall of 2024 and 2025? We rounded up some of the top conferences, both virtual and live, that are on the calendar. | Here's our roundup of some of the top events in healthcare scheduled in the fall of 2024 and 2025.

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Dispute over Duchenne gene therapy highlights thorny access issues

STAT

Finally, it seemed, Sarah Jenssen would have a chance to get a treatment that her family hoped could help her. A gene therapy for Sarah’s condition, Duchenne muscular dystrophy, won a wide approval from the Food and Drug Administration earlier this year. The authorization encompassed most patients with the degenerative neuromuscular disorder, regardless of their age or whether or not their disease had advanced to the point that they used wheelchairs.

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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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Integrating SARS-CoV-2 Surveillance Testing Among Patients Receiving Dialysis Feasible, Requires Improvements

Pharmacy Times

Although disease screening reached high-risk patients, uptake was low, necessitating additional incentive to participate in voluntary testing.

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HHS OIG finds gaps in opioid treatment for Medicare, Medicaid enrollees

Fierce Healthcare

Many counties do not have medication for opioid use disorder (MOUD) services available through providers and treatment programs, and even in counties that do, Medicare and Medicaid beneficiaries of | A new report from HHS OIG looked at access to medication for opioid use disorder services and found many high need counties do not have specialized providers.

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Fun Fact: Handwashing Was Not Accepted in Hospitals Until the Late 19th Century

Pharmacy Times

The work of Obstetrician Ignaz Semmelweis lives on in medical protocols today.

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Senate Democrats introduce bill to boost rural, safety-net hospital obstetrics pay

Fierce Healthcare

The chair of the Senate Finance Committee and several of his Democratic colleagues have introduced a bill that would increase Medicaid payments to rural and safety net hospitals for maternity care. | The Keep Obstetrics Local Act, which is backed by several provider groups, aims to address obstetrics service line closures and maternal mortality.

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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+: Regeneron, Sanofi blockbuster Dupixent wins FDA approval for COPD

STAT

Dupixent is already a blockbuster therapy for a range of immune-mediated diseases, but the Food and Drug Administration’s approval of the drug for chronic obstructive pulmonary disease greatly expands its reach — and could give it an edge over rival treatments in development. The FDA decision, announced Friday, was based on a pair of late-stage trials that found Dupixent helped patients with the chronic lung condition, reducing the rate of flare-ups and improving their breathing.

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From PDURS to D2C, Frontiers Health speaks to cutting edge healthcare news

pharmaphorum

Stay up to date on cutting edge healthcare news, from PDURS to D2C, with Frontiers Health. Explore the latest in digital health trends and innovations.

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STAT+: Q&A: MedStar Health’s Raj Ratwani on health AI and the battle raging over regulation

STAT

In the raging debate about how to regulate artificial intelligence in health care, “there seem to be two camps that are emerging,” says Raj Ratwani, vice president for scientific affairs at MedStar Health. On one side is the heavyweight Coalition for Health AI , now home to over 4,000 health care organizations looking to be involved in the AI regulation conversation — even the Food and Drug Administration.

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CMS: Medicare Advantage, Part D premiums are stable for 2025

Fierce Healthcare

Medicare's open enrollment window opens in a few weeks, and the Centers for Medicare & Medicaid Services is offering a broad look at the landscape around Medicare Advantage and Part D before si | Medicare's open enrollment window opens in a few weeks, and the Centers for Medicare & Medicaid Services is offering a broad look at the landscape around Medicare Advantage and Part D before signups begin.

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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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Teclistimab Demonstrates Continued Deep, Durable Responses in Long-Term Follow-Up From MajesTEC-1 Trial

Pharmacy Times

Notably, of the 38 participants who remained on treatment, 37 have switched to less frequent dosing and all have maintained responses.

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SEC charges Cassava over 'misleading' Alzheimer's claims

pharmaphorum

Cassava Sciences will pay $40m to settle SEC charges that it made misleading claims about a phase 2b study of Alzheimer's candidate simufilam.

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‘Rivers you think are pristine are not’: how drug pollution flooded England’s national parks – and put human health at risk

The Guardian - Pharmaceutical Industry

High levels of antibiotics and other drugs have been found in water in the country’s most treasured and protected landscapes, raising concerns over antimicrobial resistance Photographs by Christopher Thomond Nestled within the Peak District national park, the stream known as Brook Head Beck meanders between undulating green hills. It is mossy and dank by the river, surrounded by the gentle trickling sound of water, the smell of leaves starting to rot underfoot, and a weave of branches overhead w

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Could GenAI auto-generate entire regulatory dossiers?

pharmaphorum

Discover how GenAI leverages cutting-edge technology to automate the generation of regulatory dossiers, saving time and resources for your organization. Explore how GenAI can streamline the process and enhance efficiency.

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Epic's countermove: Calls for Carequality, Particle Health to go public with patient privacy dispute

Fierce Healthcare

Electronic health records giant Epic wants a behind-the-scenes dispute with Particle Health over patient data made public, saying the startup has mischaracterized the events in its antitrust lawsui | Electronic health records giant Epic wants a behind-the-scenes dispute with Particle Health over patient data made public, saying the startup has mischaracterized the events in its antitrust lawsuit.

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Pruritus in PBC: Understanding its impact and the need for raising awareness

pharmaphorum

Pruritus, or itching, is a common symptom of Primary Biliary Cholangitis (PBC). Learn more about its impact and the importance of raising awareness about this condition.

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FDA Approves Selpercatinib For Pediatric and Adult Patients With RET-Mutated MTC

Pharmacy Times

The indication is for adult and pediatric patients aged 2 years and older with advanced or metastatic RET-mutated medullary thyroid cancer (MTC) who require systemic therapy.

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Sanofi's Dupixent scores double COPD win in US, China

pharmaphorum

Sanofi's Dupixent scores double COPD win in US, China Jonah.

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Pharmacists Can Suggest Vitamin D Supplementation to Benefit Cardiometabolic Health

Pharmacy Times

Vitamin D supplementation improved total cholesterol levels, systolic blood pressure, diastolic blood pressure, and all glycemic parameters.

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UNICEF secures one million mpox vaccines for Africa

Pharmaceutical Technology

Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.

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Is pizza healthy if you have diabetes?

The Checkup by Singlecare

What’s one of the world’s most loved foods? Pizza! A favorite of kids and adults alike, the Italian staple is a common comfort food. From gooey cheese to crunchy pepperoni, it’s no wonder the savory meal is so popular. If you have Type 1 diabetes or Type 2 diabetes , you might wonder if it’s possible to enjoy pizza as part of a diabetes management plan.

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BMS ends decades-long drought in novel schizophrenia drugs

pharmaphorum

BMS' acquisition of Karuna looks set to pay off after it gets FDA approval for the schizophrenia drug at the heart of the $14bn takeover

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First-in-class therapy approved for schizophrenia

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for schizophrenia in adults. “Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” shared Dr Chris Boerner , PhD, Board Chair and Chief Executive Officer at Bristo

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The FDA is ‘making sandwiches,’ ‘breakfast salad’ in DC, and what keeps us from choking on food

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. In a new study in JAMA Oncology , researchers found an association between oral bacteria and head and neck squamous cell cancer. The bacteria didn’t cause the cancer, but indicated up to a 50% higher risk.

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How hospital lobbyists are leveraging revenue cycle data to win over Washington

Fierce Healthcare

Timely access to individual and collective revenue cycle data streams is making the difference for hospital lobbyists petitioning Washington for more favorable healthcare policy, say representative | Timely data aggregation is a key weapon in the arms race with payers over issues like medical debt, claims denials and pay interruptions, AHA and FAH policy heads told a room of hospital revenue cycle leaders at a recent vendor event.