Wed.Mar 27, 2024

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Akebia's Vafseo finally gets its shot at US chronic kidney disease market after FDA approval

Fierce Pharma

Akebia never lost confidence in its oral chronic kidney disease (CKD) anemia drug Vafseo, even after the FDA nixed its first approval bid two years ago with a complete response letter.

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Why Mass General Brigham Wants to Move 10% of Patient Care to the Home

MedCity News

At HIMSS24, Heather O’Sullivan, Mass General Brigham’s president of healthcare at home, said that the health system wants to move 10% of all its medical patients to the home. She argued that there is “no greater model of care for being patient-centric,” and highlighted the care modality’s ability to alleviate burnout for some healthcare workers.

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Trending Sources

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Sanofi inks 3 distribution pacts in India and Korea for CNS drugs and vaccines

Fierce Pharma

For various reasons, pharma firms often favor distribution pacts rather than relying on local subsidiaries to market their drugs. | As pharma firms increasingly favor distribution pacts rather than relying on local subsidiaries to market their drugs, French major Sanofi has enlisted local companies to enhance the profile of its medicines across South and East Asia.

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Novocure’s Electrical Cancer Therapy Shows It Can Treat Tumors in the Brain

MedCity News

Novocure said its “Tumor Treating Fields” met the main goal of a pivotal study enrolling non-small cell lung cancer patients with brain metastases. However, results for the electricty-based treatment fell short of statistical significance on several secondary endpoints.

Patients 117
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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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More revamp at Bayer as it axes 90 at its U.S. headquarters in New Jersey

Fierce Pharma

At a recent skull session in a conference room at Bayer’s U.S. | Bayer is laying off 90 of its employees at its United States headquarters in Whippany, New Jersey, part of its ongoing restructure which CEO Bill Anderson has said will cost many their jobs.

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Improving Interoperability and Health Equity With Health Information Exchange Networks [Sponsored]

MedCity News

In a webinar sponsored by DocuSign, scheduled for April 16 at 1 pm ET, DocuSign will discuss the benefits of its collaboration with the Michigan Health Information Exchange Network’s (MHIEN) arm, Velatura and how it can function as a model for interoperability.

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Japan clears first CLDN18.2 drug, Astellas’ Vyloy

pharmaphorum

Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment for stomach cancer. The Ministry of Health, Labour and Welfare (MHLW) has cleared Vyloy (zolbetuximab) for use in combination with chemotherapy for patients with HER2-negative CLDN18.2-positive advanced or recurrent gastric cancer that cannot be treated with surgery.

Patients 109
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Behavioral Healthcare in the Classroom – Understanding How Autism Care Operates Between Systems

MedCity News

Autism and intellectual and developmental disability (IDD) care provides a unique opportunity for our healthcare system and our education system to function together.

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Brainomix AI shows its worth in AZ pulmonary fibrosis trial

pharmaphorum

Brainomix's e-Lung AI can accurately identify idiopathic pulmonary fibrosis patients most likely to progress and could inform the clinical trial design for new therapies

Patients 105
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Leveraging Digital Tools to Optimize Manufacturing Processes

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses how companies can leverage digital tools like artificial intelligence and machine learning to optimize manufacturing processes and ensure efficient production.

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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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Medical Sales Rep Recruitment: Implementing an effective selection process for better results.

MaBiCo

Medical Sales Rep Recruitment: Implementing an effective selection process for better results. For most organizations, recruiting plays a pivotal role in driving sales effectiveness, even though it remains one of the most challenging aspects to execute effectively. Several sales leaders think their companies have mastered recruitment, while others may consider it as less important compared to other SFE (sales force effectiveness) drivers.

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Does the Passing of a No Behavioral Health-Cost Sharing Law Have Any Bearing on Spending?

Pharmaceutical Commerce

A study investigates how a New Mexico law can impact patients’ out-of-pocket costs surrounding mental health and substance use disorder medications.

Medical 105
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Dissatisfaction with NHS ‘at record high’

pharmaphorum

More than half (52%) of people who participated in a major survey of the GB public were dissatisfied with the NHS, as staff shortages, strikes, and record waiting lists take their toll. The results from the annual British Social Attitudes (BSA) survey came from 3,000 people interviewed across England, Scotland, and Wales and showed that less than a quarter (24%) were satisfied with the health service, a 29 percentage drop in three years.

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Strong growth for Sweden’s pharmaceutical exports

European Pharmaceutical Review

According to SwedenBIO, Sweden‘s life sciences industry is witnessing a continued increase in export values. Based on statistics from Statistics Sweden, at SEK 152.5 billion, exports of pharmaceuticals reached a total of 7.3 percent of Sweden’s total export value. SwedenBIO highlighted that this is an almost 10 percent increase since 2022. Value of Swedish pharmaceutical exports Swedish pharmaceuticals exports are currently “significantly larger” than exports of iron and steel.

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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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Teva UK partners Closed Loop on personalised medicine

pharmaphorum

Teva UK has joined forces with techbio company Closed Loop Medicine to develop digital companions for pharma products that could provide personalised medicine

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First-in-class biologic approved for rare lung disease

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). According to Merck (MSD outside of the US and Canada), WINREVAIR is the first activin signalling inhibitor therapy authorised for PAH.

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FOLX Health, Crisis Text Line Partner To Support LGBTQIA+ Community

MedCity News

Through a new partnership, FOLX members can gain access to crisis counselors through Crisis Text Line in addition to their support from the FOLX Health care team.

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

A report by Allied Market Research has predicted that the global pyrogen testing market will value $3.3 billion by 2032. The market is predicted to grow at a CAGR of 8.2 percent from 2023 to 2032, according to the research. Drivers of the pyrogen testing market Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market.

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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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PhaSER Biomedical and the Sanders TDI partner for clinical drug discovery research

PharmaTimes

PhaSER will provide 8HUM mouse models for the TDI to accelerate a pipeline of novel therapeutic targets

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Pharma Pulse 3/27/24: What's the ROI on GenAI? Virtual Second Opinions Save Over $8,700 Per Patient & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 100
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LifeArc provides £750,000 fund for clinical trial to treat neuroferritinopathy

PharmaTimes

The progressive and incurable brain disorder currently affects approximately 100 patients worldwide

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What’s in store for mRNA therapeutics in 2024?

PM360

We’re about to see a seismic shift in mRNA therapeutics as the field erupts with new drugs under investigation. Clinical development projects have grown from just a few dozen before the pandemic to 1,503 programs today, according to clinicaltrials.gov. In 2024, we will start seeing more of these programs hit the market, solidifying the viability of mRNA as a powerful and versatile therapeutic platform.

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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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Challenges in Trial Access and Treatment for Women with Chronic Illnesses

PharmExec

In this Pharmaceutical Executive video interview, Marie Teil, Global Head of UCB’s Women of Childbearing Age Program, discusses the specific challenges women with chronic illnesses face when it comes to accessing and participating in clinical research.

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Oncology in 2024: The clinical trial trends reshaping the role of CROs

Pharmaceutical Technology

CROs are fundamental to the development of cancer treatments but face multiple challenges. We analyze the biggest trends in oncology and the technological solutions available to CROs to optimize efficiencies.

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Artificial Intelligence Blog Series: Metadata Generation for Digital Content

Clarivate

Special collections are often the gem of a library and deserve to be easily accessible to library patrons. At Ex Libris, part of Clarivate, we are prioritizing this vision as we work on metadata enrichment via AI for digital resources. Special collections include unique material in a variety of formats, from rare historical documents to contemporary records and photographs and everything in between, such as books, newspapers and articles.

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Bioanalytical Methods to Optimize Drug Development: Hybrid LC-MS vs LBA

PharmaTech

Drs Dawn Dufield and Dominic Warrino, KCAS Bioanalytical and Biomarker Services, share expertise on using Hybrid LC-MS versus LBA for bioanalytical analysis.

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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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Which drugs are most likely to be approved in Cryopyrin-Associated Periodic Syndromes?

Pharmaceutical Technology

Cryopyrin-Associated Periodic Syndromes disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.

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Navigating the Psychedelic Renaissance: Emerging Mental Health Therapies and the Pharmacist’s Role

Pharmacy Times

Psychedelic medicines such as psilocybin, MDMA, ketamine, and LSD have been shown to have a significant impact on conditions such as major depressive disorder, generalized anxiety disorder, and post-traumatic stress disorder in clinical trials.

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Which drugs are most likely to be approved in Complicated Intra-Abdominal Infections?

Pharmaceutical Technology

Complicated Intra-Abdominal Infections disease is an indication for drug development with over 20 pipeline drugs currently active according to GlobalData.

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Enhance Early Protocol Design with Evidence-Driven Insights

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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.