Wed.Dec 06, 2023

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FDA endorses Novartis' 'pipeline in a pill,' granting first nod for potential blockbuster Fabhalta

Fierce Pharma

With an FDA approval in PNH, Novartis has gained its first nod for iptacopan, dubbed two months ago “a pipeline in pill," by analysts at ODDO BHF.

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Which Digital Health Startups Shined the Brightest in 2023?

MedCity News

CB Insights released a list of what it deems to be the 50 most promising digital health companies of 2023. The market research firm said that the startups on the list are working to improve four main aspects of healthcare: personalization, efficiency, equity and accessibility.

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Daiichi Sankyo scores $182M from Novartis settlement in long-running patent case

Fierce Pharma

After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. | In 2017, Daiichi's former subsidiary Plexxikon alleged that Novartis stepped on its Zelboraf patents with its GSK-acquired medicine Tafinlar. Many years later, Novartis is settling the case.

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Artificial Intelligence Changing the Landscape for Healthcare Social Media Marketing

PharmExec

Experts from Hootsuite noted that the primary social media ROI concern for healthcare companies is the time and money it takes to maintain a multi-platform presence.

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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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SABCS: Handing Novartis a win, Lilly's Verzenio barely misses overall survival goal in first-line breast cancer

Fierce Pharma

Novartis’ Kisqali is getting a leg up in the CDK4/6 breast cancer realm as another rival failed to significantly extend patients’ lives in a pivotal trial. | Novartis’ Kisqali is getting a leg up in the CDK4/6 breast cancer realm as another rival failed to significantly extend patients’ lives in a pivotal trial.

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Seattle Children’s Hospital launches BrainChild Bio for CNS therapies

Pharmaceutical Technology

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

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Canopy Emerges from Stealth Selling ‘a Wearable Panic Button’ for Healthcare Workers

MedCity News

Canopy has emerged from stealth as a startup focused on protecting healthcare staff from increasing levels of violence. The company’s product, called Canopy Protect, involves wearable monitors that healthcare staff can press when they feel threatened, as well as a system that allows a hospital to monitor all physical areas of the organization.

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Sanofi expands genAI drug discovery pact with Aqemia

pharmaphorum

Sanofi has deepened an existing collaboration with artificial intelligence specialist Aqemia in the latest among a flurry of collaborations between pharma companies and generative AI (genAI) companies. The French pharma group has signed a multi-year agreement with Paris-based Aqemia, focused on the discovery of small-molecule drug candidates across multiple therapeutic categories, through the application of genAI and deep physics algorithms that can model molecular interactions.

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Paving the Way to Trust in Healthcare AI

MedCity News

Through rigorous validation processes, unwavering transparency, gradual implementation, and a steadfast commitment to preserving the human touch, healthcare IT providers can unequivocally demonstrate that AI is a reliable and trustworthy ally in the intricate and evolving landscape of healthcare.

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Reviewing the FDA’s Regulatory Approach to Dietary Supplements

PharmExec

National Library of Medicine study emphasizes inadequacies in ensuring the safety and efficacy of over-the-counter dietary supplements.

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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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Novartis Nabs FDA Nod for Rare Disease Drug Rival to AstraZeneca Meds

MedCity News

FDA approval of Novartis’s Fabhalta makes the drug the first approved oral therapy for rare blood disorder paroxysmal nocturnal hemoglobinuria. With clinical data showing superiority versus two infused AstraZeneca drugs, Novartis’s pill is well-positioned to take market share from those blockbuster products.

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Novartis secures first-of-a-kind haematology approval

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Novartis’ Factor B inhibitor, Fabhalta ® (iptacopan) provides comprehensive control of red blood cell (RBC) destruction, according to the company. Novartis releases data for potentially “practice-changing” PNH medicine Key Phase III data for iptacopan “In clinical studies, iptacopan was superior to anti-C5s in haemoglobin improv

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What Excites One Mayo Clinic Radiologist About AI in Her Field

MedCity News

Dr. Wendaline VanBuren, a radiology chair at Mayo Clinic, thinks that AI is in the beginning stages of improving radiologists’ workflows. Some of the most developed radiology AI research projects at Mayo center on image segmentation and 3D printing, she said. In the future, she’s excited to see more tools that aid radiologists in triage and lesion measurement.

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Study reveals motor neuron region is affected in ALS

PharmaTimes

The neurological condition currently affects one in 300 people in the UK - News - PharmaTimes

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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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The Last Mile: How Hospitals Can Use Data For Better Care Orchestration and Patient Flow

MedCity News

Too often, executives look to data retrospectively to understand what has happened, rather than using data prescriptively to understand what is likely to happen and, in turn, how to best respond.

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IGM jettisons workforce and blood cancer programme to refocus pipeline

Pharmaceutical Technology

IGM will lay off 22% of its staff and suspend four clinical activities to advance autoimmune diseases and colorectal cancer programmes.

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Elevating Patient Engagement to Increase Retention

MedCity News

Recognizing and responding to this new emphasis on patient engagement isn’t easy. It requires providers to abandon a long-held model of healthcare with clinicians squarely at the center in favor of one in which the patients are in charge – and easily lost – if their wishes are not met.

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Embracing automation in sterile manufacturing

European Pharmaceutical Review

In the interview, conducted at CPHI Barcelona, Krishna Venkatesh, Global Head, Sterile Manufacturing Operations at Dr Reddy’s Laboratories explores industry’s growing focus on achieving end-to-end connectivity, as well as the potential of automation and track and trace solutions. Venkatesh, who is responsible for sterile injectable manufacturing and operations within Dr Reddy’s global organisation, also emphasises the role of data analytics, artificial intelligence, and low-cost automation

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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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A Modern Approach to Aging: Medicine for a Broken System

MedCity News

Our current system is broken. It only allows for the evaluation of symptoms and the treatment of disease. We need to adapt to the reality of an aging population and encourage everyone to age well.

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4 historic FDA approvals from 2023

PharmaVoice

This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.

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Female Incontinence: A Public Health Crisis?

MedCity News

UI affects 78 million women in the U.S. while fecal incontinence affects 12 million. Prevalence is rising. Age and obesity are associated with increased risk of UI, and both contribute to its increased incidence. Globally, hundreds of millions of women are affected.

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Secretary of state sets out priorities for UK health and social care systems

PharmaTimes

The commitments will make health systems faster, simpler and fairer for patients - News - PharmaTimes

Patients 102
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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.

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Managing Creditor Relationships During Cash-Flow Hardships

MedCity News

Many new to financing negotiations try to paint a rosy picture and offer unrealistic terms or revenue expectations to improve a soured relationship. This will quickly backfire and result in defaults, which not only incurs additional costs, but can rupture trust and spoil relationships.

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Top Health Trends On the Horizon in 2024

PharmExec

An overview of the nine biggest developments to expect across the healthcare industry in the year ahead.

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Daiichi Sankyo unit claims $182m in Novartis patent dispute

pharmaphorum

Daiichi Sankyo unit claims $182m in Novartis patent dispute Phil.

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An Outlook on Data-Powered Patient Support

Pharmaceutical Commerce

Matt Wolf, president of biopharma services, Cencora, discusses the importance of partnership in helping to combat prescription drug abandonment and non-adherence.

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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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Merck pummelled as MS hope fenebrutinib dies in phase 3

pharmaphorum

Merck pummelled as MS hope fenebrutinib dies in phase 3 Phil.

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Change on the horizon: The evolving IP legal profession

Clarivate

By the year 2030, it is likely the legal space will look and operate differently to today, resulting in reshaping the way IP professionals at law firms and in-house councils work. What could this mean for the future of the IP legal profession? Today’s global workforce is experiencing significant, swift and continuous shifts. Customer needs are evolving.

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Taisho says $5bn management buyout will rev up business

pharmaphorum

Taisho says $5bn management buyout will rev up business Phil.

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Who Moved My Prescription?

Pharmaceutical Commerce

While new forms of pharmacy continue to surface beyond brick-and-mortar retail, a look at what is driving this shift in perspective—and "pharmacies of the future"—is warranted.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.