Wed.Nov 15, 2023

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Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

Fierce Pharma

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.

Marketing 352
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Highly Cited Researchers 2023: The evolution of our evaluation and selection policy to support a robust scholarly landscape

Clarivate

Every year, the unveiling of the Highly Cited Researchers list sparks anticipation within the global research community as both researchers and their affiliated institutions or organizations scrutinize the list. Today, we present our 2023 list , recognizing 6,849 individuals from more than 1,300 institutions across 67 countries and regions. These Highly Cited Researchers stand out for their significant and broad influence in various scientific and social science domains, representing a small fra

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Germany considers banning the export of Novo Nordisk's Ozempic

Fierce Pharma

How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? | How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? The craze is such that Germany’s drug regulator is considering banning the export of Ozempic, according to a report in Der Spiegel magazine.

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FDA Approves CorMedix Inc’s Treatment for Bloodstream Infections in Patients Receiving Dialysis

PharmExec

Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.

Patients 119
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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2seventy suffers sales slump on high production charges for BMS-partnered CAR-T med Abecma

Fierce Pharma

If you’re curious about the pitfalls of CAR-T drug commercialization, look no further than Bristol Myers Squibb’s Abecma partner 2seventy bio. | After reporting a sizable revenue decline for its BMS-parntered multiple myeloma cell therapy in 2023’s third quarter, 2seventy stands out as a prime example of the dangers of scaling up a process before suffering lower-than-expected demand, one group of analysts contends.

Sales 260
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Gilead’s $285M Confidence Vote for Next-Gen Cancer Med & New Cell Therapy Tech

MedCity News

Gilead Sciences is increasing its stake in partner Arcellx and expanding the cell therapy alliance the companies started in 2022. The deal expands the lead partnered program to more cancers and gives Gilead a chance at another Arcellx cell therapy candidate made with different technology.

Leads 114

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How to Leverage the Patient Journey for Market Strategy Development

MedCity News

A hearing healthcare veteran consultant, who has significant hearing loss, describes 7 market-tested best practices. Understanding the consumer-patient journey is crucial to developing strategic priorities for companies across hearing healthcare, from hearing aids to cochlear implants to gene/drug therapy.

Marketing 109
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2024 Pipeline Report: First-World Focus

PharmExec

Pharm Exec’s 19th annual report on the trends of the day in drug development examines the surging investment in new treatments and advances for so-called “first-world” conditions, capturing the landscape of five expanding therapeutic areas: weight loss, osteoarthritis, Alzheimer’s disease, COPD, and psychedelics.

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How Do We Know If Digital Mental Health Solutions Are Effective?

MedCity News

There are several ways to know if a digital mental health solution is working, including whether it has proven clinical outcomes or if it’s improving access to care, executives said during a panel discussion.

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CHMP recommends new immunotherapy delivery method

European Pharmaceutical Review

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq ® (atezolizumab). Roche’s monoclonal antibody cancer immunotherapy was recommended for all indications in which Tecentriq intravenous (IV) has been previously approved, including certain lung, liver, bladder and breast cancer types.

Medicine 105
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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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Cytovale Snags $84M To Commercialize Early Sepsis Detection Test

MedCity News

Cytovale, a San Francisco-based medical diagnostics company, raised $84 million in Series C funds to advance the commercialization of its diagnostic test for early sepsis detection. Using standard blood draws, the test provides results in under 10 minutes. It is meant to detect sepsis in patients who present to hospital emergency departments.

Medical 108
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NHS sets sights on ending cervical cancer by 2040 with HPV vaccine drive

Pharmaceutical Technology

Chief executive Amanda Pritchard says vaccination and screening could make eliminating cervical cancer a reality in the next two decades.

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Medtech’s iPhone Moment: Pioneering Patient Experience-Focused Design in Medical Devices

MedCity News

Flexible, portable medical diagnostic devices are the future, augmenting equity and access to quality healthcare. That means designing for patients as well as caregivers, creating devices that are intuitive, easy to use, and easily adaptable to various environments.

Medical 106
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Study shows how congenital heart disease affects blood supply before birth

PharmaTimes

CHD is a common birth defect that affects the development of the heart and brain - News - PharmaTimes

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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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AdventHealth CEO’s 3 Rules For Employee Retention

MedCity News

At a conference last week, AdventHealth CEO Terry Shaw discussed how his organization fosters a culture in which its workers feel heard and supported. Some of his advice included making necessary changes based on employee feedback and providing ample opportunities for career advancement.

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A biotech tackles drug discovery with transcription factor know-how

PharmaVoice

Talus Bio, which developed a platform to map transcription factors, has a lead cancer candidate in the works and consults with other industry players in the complicated biology.

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Funding to Improve Drug Availability

MedCity News

Government funding plays a major role in the advancement of drugs, including monoclonal antibodies, which are extremely expensive to produce and can take months to develop.

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Signal: Pfizer cuts 500 UK jobs in restructuring after posting Q3 loss

Pharmaceutical Technology

The company has struggled this year on the back of reduced Covid-19 medication sales and is now streamlining costs.

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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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FDA Issues Warning Letter to Amazon Over Sale of Unapproved Ophthalmic Products

PharmExec

The eye drops listed in the warning letter are defined as drugs because they are intended to use for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure of any function of the body.

Sales 75
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Sandoz mobilises critical medicine production in Europe

European Pharmaceutical Review

Two new production facilities have opened in Europe, Sandoz announced on 10 November 2023. The €150 million facility in Kundl, Austria will produce the antibiotic penicillin, while the new €25 million facility in Holzkirchen, Germany will be Sandoz’s new Biosimilar Development Center. Launch of these new facilities help to ensure sustainable access to quality antibiotics and spearhead development of biosimilars, Sandoz noted.

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JCVI advises UK government on gonorrhoea and mpox vaccinations

PharmaTimes

Both programmes will be offered to those most at risk of developing STIs - News - PharmaTimes

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Elucid’s $80m round heads latest digital health financings

pharmaphorum

Elucid’s $80m round heads latest digital health financings Phil.

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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 Approves Defencath to Treat Catheter-Related Bloodstream Infections

Pharmaceutical Commerce

Patients with kidney failure administered chronic hemodialysis who received DefenCath showed a statistically significant lower incidence of catheter-related bloodstream infections.

FDA 52
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Bayer pulls Aliqopa from US for follicular lymphoma

pharmaphorum

Bayer pulls Aliqopa from US for follicular lymphoma Phil.

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UK JCVI recommends chickenpox vaccine in early childhood

Pharmaceutical Technology

The UK JCVI has recommended the addition of chickenpox vaccine to the country's routine immunisation programme for children.

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Australian retail pharmacy enters clinical trials market

pharmaphorum

Australian retail pharmacy enters clinical trials market Phil.

Retail 90
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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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Using Predictive Analytics to Accelerate Time to Market in Healthcare

Clarify Health

In the business of healthcare, time is of the essence. Health plans and care delivery organizations face steep competition for customers and patients, so it’s essential to move swiftly to gain customer loyalty and market share when launching a new health plan or service line. But, as the saying goes, only fools rush in. Healthcare leaders need to look at market trends, population health statistics, and other data to make informed growth decisions.

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AI Can Save Pharma Time and Money, But Concerns Persist With Data Security

Pharmaceutical Commerce

Study estimates that up to 20% of the costs for clinical research is associated with the manual transfer and verification of data from the electronic medical record to a data capture system.

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The Future of the Medical Sales Profession: Challenges and Approaches in a Fast-Changing Healthcare Market.

MaBiCo

The Future of the Medical Sales Profession: Challenges and Approaches in a Fast-Changing Healthcare Market. Medical sales representatives are professionals who promote medical and health related products or services to healthcare providers, such as hospitals, clinics, pharmacies, and doctors. These professionals are responsible for educating customers about the features, benefits, and usage of their products, as well as building relationships with them.

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Study Digs into Patient Access to Electronic Health Information

Pharmaceutical Commerce

Findings suggest that participants nationwide who were offered and accessed their online medical record has more than doubled in the past eight years, but racial and ethnic disparities continue.

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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.