Wed.Dec 11, 2024

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December 11, 2024: Home Blood Pressure Telemonitoring in Black and Hispanic Patients With Stroke, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Gbenga Ogedegbe In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, December 13, 2024, at 1:00 pm eastern.

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ASH 2024 discussions shine spotlight on advances in haemophilia treatments

Pharmaceutical Technology

When a room of physicians at ASH 2024 was asked whether they had prescribed a gene therapy in a commercial context, only a handful said yes.

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CDMO Selection: The Ultimate Checklist

Drug Patent Watch

The biopharmaceutical industry has witnessed a significant surge in the number of therapeutic molecules in development, leading to a corresponding increase in the number of contract development and manufacturing organizations (CDMOs). This growth has created a competitive landscape where pharmaceutical companies must carefully evaluate and select the right CDMO partner to ensure the success of their projects.

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Er-Kim and Ascendis’ endocrine therapy agreement extended in Eurasia

Pharmaceutical Technology

Er-Kim has extended its exclusive agreement with Ascendis Pharma for endocrinology treatments across multiple countries in Eurasia.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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How to Develop a Sustainable Generic Drug Development Strategy

Drug Patent Watch

The pharmaceutical industry, particularly the generic drug sector, faces significant challenges in adopting sustainable practices. As the world grapples with the consequences of climate change, companies must adapt their operations to reduce environmental impacts while maintaining cost-effectiveness and regulatory compliance. This article outlines key considerations and strategies for developing a sustainable generic drug development strategy.

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Opening the Gates to New Study Coordinator Talent and Workforce Mindsets

ACRP blog

Youve probably heard it all before: The clinical research enterprise has a problem with expecting new hires in what are often basically low-paying, entry-level positions to already have two or more years of experience with the positions duties. Its a talent acquisition model that does no one any favors, especially at the study site level where a healthy pipeline of new clinical research coordinators (CRCs) would go a long way to alleviating delays in trial conduct.

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Leriglitazone meets endpoint in trial for cerebral adrenoleukodystrophy

Pharma Times

Promising results set stage for European marketing authorization

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Vifor Pharma offers £23m to NHS to resolve CMA investigation

Pharmaceutical Technology

If accepted, Vifor Pharma's 23m offer will "claw back" money for the NHS and close the CMA's first-ever disparagement case.

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iOnctura achieves new clinical milestones in uveal melanoma therapy

Pharma Times

Successful phase 1 study highlights potential of roginolisib

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Relation-GSK to drive fibrotic and osteoarthritis developments

Pharmaceutical Technology

Relation has announced two strategic collaborations with GSK, focusing on new therapeutics for fibrotic and osteoarthritis.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Innovating Cell-Based Solutions for Type 1 Diabetes ft. Jonathan Rigby, CEO, Sernova

XTalks

In this episode, Ayesha spoke with Jonathan Rigby, MBA, CEO of Sernova , a Canadian biotech company developing innovative cell therapy-based approaches for the management of type 1 diabetes. The companys lead innovation is an implantable bio-hybrid organ pouch, which is currently in an ongoing Phase I/II clinical trial. An estimated 537 million people are currently living with diabetes globally and this number is projected to reach 643 million by 2030, making it a pressing health issue in need o

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ASH 2024: J&J’s Tecvayli shows promise in transplant-eligible NDMM patient

Pharmaceutical Technology

The prevailing treatment paradigm for newly diagnosed multiple myeloma (NDMM) patients who have received autologous stem cell transplantation (SCT) primarily consists of chemotherapy or Johnson & Johnsons (J&J) Darzalex in combination with chemotherapy.

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Patient Engagement Collaborative Announces Eight New Members

CTTI (Clinical Trials Transformation Initiative)

Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 caregivers, patients, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communications, education, and patient engagement related to medical product regulation.

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Lilly’s £279m bet aims to boost UK life sciences sector

Pharmaceutical Technology

Lillys investment and the UK governments strategic support for life sciences and healthcare represent a pivotal moment for the industry.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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#HELICONference : health of children and young adults during the COVID-19 crisis

Sciensano

Event type: webinar Audience: general public health professionals journalist PhD students policy makers representatives of care and professional organisations scientists university staff Description: The COVID -19 pandemic has had a profound impact on the mental and physical health and family dynamics of children and young adults in Belgium. Scientific research shows that they have faced unique challenges ranging from interrupted education and socialization to increased stress and anxiety.

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Better prevention and treatment options needed for genital herpes, WHO says

Pharmaceutical Technology

Updated figures from the WHO show that more than one in five adults aged between 15 and 49 globally have the infection.

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DSCSA Beyond the November Deadline: Operationalize Compliance in the Warehouse

Pharmaceutical Commerce

Compliance with the Drug Supply Chain Security Act (DSCSA) is crucial to ensure a secure and efficient pharmaceutical supply chain. Industry experts share strategies for implementing serialized data tracking, overcoming compliance challenges, and fostering collaboration across the supply chain to maintain operational efficiency and patient safety.

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Dr Myles Greenberg becomes president and CEO of InCarda Therapeutics

Pharmaceutical Technology

InCarda Therapeutics has announced the appointment of Dr Myles Greenberg as its new president and chief executive officer (CEO).

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Siga's smallpox antiviral Tpoxx misses the mark in another mpox study

Fierce Pharma

Its dj vu for Siga Technologies and its smallpox antiviral Tpoxx. At an interim analysis of a second mpox trial, the drug again missed the mark on a key measure of disease resolution. | The antiviral didn't demonstrate efficacy in patients with the clade 2 mpox strain, matching August results in patients with clade 1 mpox.

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Overcoming the first hurdles: Navigating early phase challenges for biotechs

Pharmaceutical Technology

Appropriately planning and conducting early phase clinical trials is critical to setting the stage for successful pivotal studies.

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Trade & Channel Strategies 2024: Protecting the Pharma Supply Chain

Pharmaceutical Commerce

The seminar focuses on US supply chain resiliency, while remaining compliant and preserving patient access.

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The Innovations Shoring Up Clinical Supply Chain Integrity in the Age of Advanced Therapies

Pharmaceutical Technology

Missing and incomplete data can cause headaches for clinical trial operators; new innovations are providing an antidote.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Trade & Channel Strategies 2024: Patient-Centric 3.0 — How Direct-to-Patient is the New Commercialization Model

Pharmaceutical Commerce

Breakout session explores how direct-to-patient models shorten the time to diagnosis and therapy to improve patient outcomes.

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Targeting proteins to bring new medicines to patients with few options

pharmaphorum

In a new pharmaphorum podcast, editor-in-chief Jonah Comstock speaks with Dr Victoria Richon, CEO of Entact Bio, a company focused on the small molecule space, with its team of scientists, entrepreneurs, drug creators, and problem solvers working together to bring new medicines to patients who currently have few options.

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Trade & Channel Strategies 2024: Navigating Pharma and Its Distribution Models

Pharmaceutical Commerce

A case study explores a way to potentially transform commercial organizations, while driving revenue growth.

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AbbVie’s Tavapadon Reduces Motor Impairments in Phase III Parkinson’s Trial

XTalks

AbbVie has announced encouraging topline results from its Phase III TEMPO-2 clinical trial, evaluating tavapadon as a monotherapy for early Parkinsons disease. The trial met its primary and key secondary endpoints, demonstrating significant improvements in motor and daily living functions. These findings underscore tavapadons potential as a first-in-class treatment option, addressing unmet needs with strong efficacy and manageable side effects.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Pharma Pulse 12/11/24: Building and Maintaining Relationships with High-Profile Clients, Nearly Half of Adults With Epilepsy Use CBD Products & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Grand Rounds December 6, 2024: Opportunities and Challenges in the Use of Large Language Models for Post-Marketing Surveillance of Medical Products (Michael E. Matheny, MD, MS, MPH)

Rethinking Clinical Trials

Speaker Michael E. Matheny, MD, MS, MPH Director, Center for Improving the Publics Health Through Informatics Professor of Biomedical Informatics, Biostatistics, and Medicine Vanderbilt University Medical Center Staff Scientist, Geriatrics Research Education and Clinical Care Service Associate Director, VA ORD VINCI Tennessee Valley Healthcare System VA Slides Keywords Artificial Intelligence; Large Language Models; Surveillance; Medical Products Key Points Increasingly

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How to Achieve CDMO Operational Excellence

Drug Patent Watch

Achieving operational excellence in a Contract Development and Manufacturing Organization (CDMO) is crucial to ensure the quality and consistency of products and services. This can be achieved by implementing robust controls, optimizing workflows, and fostering a culture of continuous improvement. Here are some key strategies to achieve operational excellence in a CDMO: Implementing Robust Controls Compliance with Regulatory Guidelines : Ensure compliance with strict regulatory standards set by

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The Heartbeat of EVERSANA INTOUCH: What Makes Us Tick

Intouch Solutions

Great Talent Deserves a Great Workplace! In this season of gratitude, were especially thankful for our global team, whose relentless pursuit of improving healthcare inspires us daily. From identifying undiagnosed patients to introducing new therapies, their innovation is transformative. Recently, we asked our team why they voted us a Great Place To Work and what drives them to excel.

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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