Fri.Jun 16, 2023

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Eli Lilly's Mounjaro is primed to surpass Novo Nordisk's popular diabetes and obesity duo: report

Fierce Pharma

In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide. | In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData.

Leads 319
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Digital Health’s ROI Reckoning: How To Uncover New Value From Old Investments

MedCity News

To increase your return on technology investment, start with an audit of existing technology. Where is it falling short? Do problems stem from lack of functionality or troubles with adoption? What do all users think?

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Trending Sources

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Merck's Keytruda aims for updated stomach cancer label with positive data

Fierce Pharma

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study. | After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors.

Patients 293
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Pharma Injecting Life into Digital Health Amidst Funding Downturn

MedCity News

The consensus is 2022 was a challenging year for digital health companies. Venture capital and other startup investment in the U.S. digital health sector plummeted to $15 billion from more than $29 billion in 2021, according to Rock Health. Market analysts CB Insights similarly tracked private investment last year in U.S. digital health at $17.7 billion in 2022 — down 56% from $40.2 billion in 2021.

Pharma 108
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Game on, AbbVie. Roche's Columvi nabs FDA nod as 2nd bispecific for large B-cell lymphoma

Fierce Pharma

Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma. | Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label.

FDA 280
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FDA Approves Roche Lymphoma Drug, Bringing Competition to New AbbVie Med

MedCity News

The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.

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Recent Trends Impacting Funding and Access to Rare Disease Therapies

PM360

Funding and access are not new topics of conversation in the rare disease space. Genzyme made headlines in the ’90s when it launched the enzyme replacement therapy Cerezyme for a then-unprecedented $300,000 per year. In 2007, Alexion set a new pricing milestone of $500,000 annually for Soliris , a treatment for an ultra-rare blood disorder. As prices continued to rise, industry analysts began to publish top 10 lists cataloging extremely expensive rare disease brands.

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Survey: 58% Of Americans Had at Least 1 Issue With Health Coverage In the Last Year

MedCity News

Many insured Americans reported challenges with their insurance coverage in the last year, especially those in poorer health and those with mental health conditions, a KFF survey found.

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Working with Rare Disease Communities and Advocacy Groups

PM360

While all patient communities and advocacy groups offer patients, their families, and their caregivers support, advice, and information, rare disease patient groups can be especially tight-knit. With such limited information out there for some rare diseases, these groups are often the only resource for people looking for answers. Furthermore, these patients are typically the ones raising money for research into potential treatments and cures, as well as banding together to try to change governme

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Providence Scales Back Services in Oregon to Prep for Nurses’ Strike

MedCity News

Providence is cutting back on services at three of its Oregon facilities to brace for an upcoming nurses’ union strike. The Oregon Nurses Association has planned a five-day strike to fight for better staffing levels and working conditions.

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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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Improving Rare Disease Clinical Trial Design

PM360

According to the National Organization for Rare Disorders (NORD) , there are over 7,000 known rare diseases, with 90% having no effective treatment method or cure. 1 When an individual is diagnosed with a rare disease, they often experience fear, uncertainty, and anxiety. Obtaining a diagnosis is only the first step, leaving many without the direction or resources to find the additional medical care they need.

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How can AI be best harnessed for pharmacovigilance data?

European Pharmaceutical Review

According to a recent review funded by GSK Biologicals, artificial intelligence (AI) and machine learning (ML) seems intuitively, to be well suited to perform pharmacovigilance (PV) tasks given the large volume of data, high degree of uncertainty and need to learn from data. However, the paper highlighted the challenges these technologies hold for analytics.

Safety 91
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Here Are ChatGPT’s Limitations Compared to Specialized AI Chatbots in Symptom Assessment

MedCity News

When using ChatGPT, it’s crucial to consider the potential risks of the “hallucination effect.” This phenomenon refers to the model’s tendency to express responses with unwarranted confidence, even when the information is uncertain or inaccurate.

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Shaking up pharma: Change that leaders would like to see

PharmaVoice

Industry execs give voice to the “game changers” they believe would have the greatest impact on the healthcare ecosystem for all.

Pharma 98
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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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Illinois Tackles Library Book Bans

Copyright Clearance Center

“The hope is the risk of losing critical state funds will dissuade cities and towns from the kind of bans we’ve seen,” says PW’s Andrew Albanese.

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FDA approves off-the-shelf bispecific antibody cancer therapy

European Pharmaceutical Review

The first and only CD20xCD3 T-cell engaging bispecific antibody ( BsAb ) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) that is given for a defined period of time has been approved by the US Food and Drug Administration (FDA). Genentech’s Columvi ® (glofitamab-gxbm) is indicated for adult DLBCL patients not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

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Rosemont acquires Lucis Pharma to boost portfolio

PharmaTimes

Company will gain access to a considerable pipeline of liquid products covering various disease areas - News - PharmaTimes

Pharma 92
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Flamingo gets grant from VLAIO to accelerate RNA-focused oncology portfolio

Pharmaceutical Technology

Flamingo Therapeutics has received a research grant of €1.7m from Flanders Innovation & Entrepreneurship (VLAIO) to further advance its oncology portfolio targeting RNA. The grant will help Flamingo to support its translational research in a Phase II study of its lead clinical programme, danvatirsen, to treat head and neck squamous cell carcinoma.

Leads 69
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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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genedrive awarded test kit grant

PharmaTimes

DEVOTE grant will allow acute care patient access and a supporting infrastructure for the company - News - PharmaTimes

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Let’s Admit We All Have Bias

PM360

Let’s just say it: Everyone is biased. Yes, even in healthcare marketing. As two people who have experienced bias due to race, gender, and/or sexual identity, we can safely say that no one is capable of avoiding bias at all times, knowingly or unknowingly, even when focused on getting patients and HCPs help and information they need. In healthcare marketing, bias may be introduced at any point, starting from the clinical research stage through to creative concepting.

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FDA clears Genentech’s Columvi for adults with R/R DLBCL

Pharmaceutical Technology

Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Columvi (glofitamab-gxbm) to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The approval has been granted for patients with R/R DLBCL not otherwise specified or large B-cell lymphoma (LBCL) caused by follicular lymphoma, after two or more systemic therapy lines.

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Add Relevance to Your Marketing Plan: The Value of Personalization and Localization

PM360

It’s more challenging than ever to be a pharma marketer. Rapid changes in the market resulting from COVID-19. The shift from private practice to health system-employed clinicians. Tighter budgets. Smaller field forces. These factors, and more, make it increasingly difficult to engage hard-to-reach audiences and drive strong brand performance. Furthermore, demand for digital solutions has triggered a transition to omnichannel communications.

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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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20 Common Interview Mistakes You Should Avoid

Rep-Lite

In the competitive landscape of today’s job market, interviews play a pivotal role in the hiring process. They provide an opportunity for employers to assess candidates beyond their resumes and qualifications. However, a single mistake during a job interview can significantly impact your chances of securing the job you desire. At Rep-Lite, we understand the importance of interviews and have developed a process for helping you land your dream job in medical sales, clinical, and service team

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An Authentic Approach to LGBTQ+ Marketing Could Save Lives

PM360

Last year, 56% of the LGBTQ+ population reported discrimination when seeking medical care, 1 more than half the country offered no protection for LGBTQ+ people seeking medical care, 2 and the majority of trans individuals encountered a significant lack of medical knowledge relevant to their needs. 3 When you consider the impact of living with this situation, it’s not hard to see why one LGBTQ+ person attempts suicide every 45 seconds in the U.S.—4x the national average. 4 As members of the healt

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Employee Spotlight: Mili Bhatia

InCrowd

Mili is the SVP of Client Services at Survey Healthcare Global, the client research side of OpinionSite. Get to know more about her below! What do you love about working in the life science industry? I love that part of what we do impacts healthcare, with the ultimate goal to improve patient care. You work as the SVP of Client Services at Survey Healthcare Global , what’s the best part of your job?

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Shining a Spotlight on Rare Diseases

PM360

Don’t let the rare in rare disease fool you. While the definition of a rare disease may be a condition that impacts fewer than 200,000 people in the U.S., the fact is about 30 million people in the U.S. have a rare disease—and 300 million worldwide. That is 300 million people who had to spend an average of five years just to arrive at a diagnosis. That is 300 million people who had to visit doctor after doctor after doctor while they suffered with little relief and probably dwindling hope.

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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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ANeuroTech shares plans for major depressive disorder pivotal programme

Pharmaceutical Technology

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology.

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Elevating Caregiver Voices: Driving More Inclusive Partnership in Rare Disease

PM360

Rare disease caregivers play a unique role in the patient journey and experience. The nuances of rare diseases require caregivers to become advocates, educators, and warriors, fighting for their loved one who may not be fully supported by existing healthcare services. From tireless research into their condition, to daily up-close experience with its manifestations, caregivers are a critical part of a patient’s journey and an invaluable source of real-world data that can help healthcare professio

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Verix boosts life science AI capabilities with start-up.ai acquisition

Pharmaceutical Technology

Artificial intelligence (AI)-driven commercial optimisation platform provider Verix has purchased start-up.ai for an undisclosed sum, boosting its life science AI capabilities. start-up.ai is a group of AI specialists that helps enterprises improve their processes through AI and machine learning. The company will be merged with Verix’s AI lab, and start-up.ai co-founder and CEO Shahar Cohen will become Verix’s CTO.

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Data-Driven Connections: Linking Rare Disease Patients to Clinical Trials, Experts, and Resources

PM360

In rare disease, every challenge is magnified, beginning with the first. Simply put, identifying a disorder and receiving a formal diagnosis is at the root of myriad difficulties—from connecting a patient to a community to generating an appropriate care and treatment plan that ideally goes beyond managing symptoms to connecting a patient to clinical trials.

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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.