Fri.Mar 22, 2024

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Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli

Fierce Pharma

Sales are booming for Novo Nordisk’s GLP-1 treatments for diabetes and obesity. But that doesn’t mean the Danish company has moved on from its previous generation of blood sugar modulators. | With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP), Novo has come a step closer to bringing its revolutionary Awiqli (once weekly basal insulin icodec) to the market.

Medicine 320
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Why Every Hospital Needs a Chief Pharmacy Officer in the C-Suite

MedCity News

A CPO in the C-suite determines how a health system can move from a cost center to a revenue center with healthy operating margins by investing in specialty pharmacy services that reduce burden for healthcare staff and improve care for patients.

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Italfarmaco nabs FDA approval for new Duchenne med, teeing up sparring match with Sarepta

Fierce Pharma

At a watershed moment for Duchenne muscular dystrophy (DMD) treatment, privately held Italian drugmaker Italfarmaco has added a new therapeutic option to the armamentarium against the debilitating | At a watershed moment for Duchenne muscular dystrophy treatment, privately held Italian drugmaker Italfarmaco has added a new therapeutic option to the armamentarium against the debilitating muscle-wasting disorder.

FDA 296
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FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

MedCity News

Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Lilly CEO reaffirms commitment to Chinese market amid US threat against local biotechs

Fierce Pharma

At a time of heightened geopolitical tensions between the U.S. and China, Eli Lilly’s CEO said the Indianapolis-based company remains committed to the Chinese market. | David Ricks’ visit to China comes as Lilly has several key drug applications under review at local regulators.

Marketing 283
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Stand Tall: Lowering Health Risks for the Aging Population

MedCity News

Today, new digital solutions are emerging that provide tailored exercise programs and encourage small changes to daily life that can lead to significantly lower fall risk.

Leads 117

More Trending

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Post-Acute Care and Enablement of the Home, An Industry in Flux

MedCity News

Collaboration across key stakeholders, including home health agencies, providers, patients, health plans, and post-acute care solution providers will be critical to fully enabling the home as a preferred place of care.

Patients 114
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PAP 2024: Amy Niles Discusses Goals of the PAN Foundation

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Amy Niles, Chief Mission Officer, The PAN Foundation discusses the overall mission of the organization.

Pharma 105
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What ‘Digital Transformation’ Means to 3 Health System Execs

MedCity News

During a panel at HIMSS, three health system leaders explained what digital transformation means to them and how they’re seeking it play out at their organizations.

Medical 113
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Heart claims unlock Medicare coverage of obesity drugs

pharmaphorum

Medicare has loosened restrictions on the reimbursement of obesity drugs, thanks to clinical data showing they can improve cardiovascular outcomes, but their price could be up for negotiation.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Humana, DUOS Team Up To Support Veteran Seniors

MedCity News

Humana and DUOS have partnered to launch a new program that supports Humana’s Louisiana veteran seniors with a chronic condition. These veterans will be connected to DUOS, which can address their health-related social needs.

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IN MEMORIAM Rob Likoff

PM360

It is with immense sadness that I write this. A one of a kind, loyal, and generous friend and mentor. I will miss his humor, unrivaled intelligence, guidance, wisdom—and I can’t leave out his fashion sense, especially those killer shoes. Rest in peace my very dear friend.

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Digital diabetes tools ‘of little benefit and raise costs’

pharmaphorum

First report from PHTI concludes that digital health technologies for diabetes management deliver minimal clinical benefit and raise healthcare costs

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EMA CHMP recommends Novo Nordisk’s weekly insulin for diabetes

Pharmaceutical Technology

The EMA CHMP has recommended marketing authorisation for Novo Nordisk's Awiqli for treating diabetes in adult patients.

Marketing 105
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

pharmaphorum

Italfarmaco’s non-steroidal drug Duvyzat (givinostat) has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD)

FDA 100
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FDA grants orphan drug status to HI-Bio’s felzartamab for AMR

Pharmaceutical Technology

The US FDA has granted ODD to HI-Bio's felzartamab to treat antibody-mediated rejection (AMR) in kidney transplant recipients.

FDA 97
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Idorsia first-in-class hypertension drug gets FDA okay

pharmaphorum

Idorsia Pharmaceuticals has claimed FDA approval for aprocitentan as a treatment for resistant hypertension, becoming the first drug in the endothelin receptor antagonist class for that indication.

FDA 83
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Combination treatment could minimise cancer relapse risk

European Pharmaceutical Review

Research suggests that combining ribociclib with hormone therapy improved invasive-free survival in stage 2 or 3 HR-positive, HER2-negative early breast cancer. The study data showed that distant disease-free survival and recurrence-free survival improved when the small molecule CDK4/6 inhibitor ribociclib was used alongside a nonsteroidal aromatase inhibitor (NSAI).

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Mirador’s massive $400m first round, and other financings

pharmaphorum

It has been a bumper week for biotech financings, with a $400m Series A for Mirador heading, topping impressive rounds for Capstan, Clasp, Engrail, Enliven, and Nouscom.

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Innovate UK awards ten projects over £6m to develop new clinical tools for dementia

PharmaTimes

Dementia is estimated to affect 850,000 people in the UK and costs the nation around £23bn a year

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This pharma ‘fixer’ is now leading the charge in the Gates foundation’s tuberculosis battle

PharmaVoice

After getting her start as a nurse, Debra Weiss worked her way up the corporate ladder and is now COO of Gates MRI, which just launched its first phase 3 trial for tuberculosis.

Leads 52
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Four international teams awarded £4.7m to investigate heart and circulatory diseases

PharmaTimes

These types of conditions are responsible for 25% of all UK deaths and affect 7.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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How healthcare providers can address challenges with hospital price transparency data

Clarify Health

While healthcare price transparency regulations aim to empower patients and promote competition in the market, providers face significant challenges in implementing and complying with these requirements effectively. Implementing price transparency requires a robust technology infrastructure to collect, store, update, and disseminate pricing information effectively.

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The Value of AI, The Value of People: Charting New Waters for Consultancy

PM360

The effective ongoing incorporation of Artificial Intelligence (AI) has emerged as a pivotal force within the pharmaceutical sector, reshaping the traditional paradigms of drug discovery, development, and commercialization. However, it’s also charting new waters for consultancies supporting the sector. How do AI and strategy consultants fit together?

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Addressing Unmet Needs in Schizophrenia, Pulmonary Arterial Hypertension & NASH

PharmExec

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses the three drugs featured in their Drug Pipeline Insights Report for 2024 and which unmet needs they address.

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Revolutionizing Rare Disease Research: Unleashing the Power of Patient Advocacy and Artificial Intelligence

PM360

Exploring the role of patient advocacy groups and clinical trials while discussing the challenges faced, and how artificial intelligence and modern methods revolutionize the landscape. Despite the unique traits exhibited by approximately 11,000 rare diseases (RD), patients commonly face challenges due to the diseases’ low prevalence, including feelings of isolation and navigating overwhelming information about their condition 1.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Vanda Pharmaceuticals files patent for treatment of psychiatric disorders with r-p88 once per day

Pharmaceutical Technology

Discover how Vanda Pharmaceuticals' patent for R-P88 offers a groundbreaking treatment for psychiatric disorders, simplifying dosing and administration for patients and healthcare providers.

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HealthcareWATCH

PM360

DISCOVERIES & INNOVATION CAR T Cells May Be the Answer to a Longer Life CAR (chimeric antigen receptor) T cells just might be the secret weapon against aging. Cold Spring Harbor Laboratory (CSHL) Assistant Professor Corina Amor Vegas and colleagues have discovered that T cells are white blood cells that can attack another group known as senescent cells.

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FDA Approves Italfarmaco SpA’s Duvyzat for Duchenne Muscular Dystrophy

PharmExec

Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.

FDA 52
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It’s Time We Got the Most Out of Medical Affairs Data

PM360

Field Medical Affairs exists as a trusted relationship-builder within the medical industry and turns to advance science to help the discussions between MSLs and HCPs on treatment possibilites and scientific concerns. Field Medical Affairs is an essential bridge between pharmaceutical clinical development and commercial delivery. Without the imperative of immediate commercial outcomes, Field Medical Affairs also exists as a trusted relationship-builder in which medical science liaisons (MSLs) and

Medical 52
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.