Sat.Mar 02, 2024 - Fri.Mar 08, 2024

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog

By Mark A. Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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March 7, 2024: New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials

Rethinking Clinical Trials

Dr. Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.

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FDA doubles down on patient engagement to support rare disease research

Pharmaceutical Technology

For Rare Disease Day, several panels organised by the FDA discussed the importance overcoming accessibility barriers during drug development.

Research 195
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Revolutionizing Rare Disease Treatment: Embracing the Patient-Centric Transformation in Pharmaceutical Customer Engagement

Pharmaceutical Commerce

Navigating the complex landscape of healthcare coverage can be an intimidating task, especially for patients with rare diseases for which treatments often come with a high price tag.

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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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Enhancing Diversity in Clinical Trials: Canada’s Promise

ACRP blog

Canada has promise in supporting clinical trial diversity in local and global studies. Some 23% of its 8.4 million residents were born elsewhere (in countries led by India, China, and the Philippines), according to the 2021 census.{1}This figure is forecast to rise to as much as 30% of Canada’s population by 2036.{2} Canada’s “open-door” immigration policy has also led to the fastest growing population among the G7 countries, which also include France, Germany, Italy, Japan, the Unit

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Oncologists encounter parent reluctance for clinical trials of paediatric cancer cases

AuroBlog - Aurous Healthcare Clinical Trials blog

Oncologists during clinical trials of paediatric cancer cases are seen to encounter parent reluctance. Viewed as a significant challenge, cancer care centres have observed that it comes in because of hesitancy by parents to enroll their children.

More Trending

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Amylyx ALS drug fails crucial study, putting company’s future in doubt

Bio Pharma Dive

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

Drugs 342
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March 6, 2024: In This Week’s PCT Grand Rounds, Public-Private Partnerships in Health AI

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Michael Pencina of Duke University will present “Public-Private Partnerships in the Trustworthy Health AI Ecosystem.” The Grand Rounds session will be held on Friday, March 8, 2024, at 1:00 pm eastern. Pencina is a professor of biostatistics and bioinformatics and the vice dean for data science in the Duke University School of Medicine.

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There’s a Surprisingly Simple Way to Remove Microplastics From Your Drinking Water

AuroBlog - Aurous Healthcare Clinical Trials blog

Tiny fragments of microplastics are making their way deep inside our bodies in concerning quantities, significantly through our food and drink. Scientists have now found a simple and effective means of removing them from water.

Scientist 219
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Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

Medicine 278
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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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FDA delays decision on Lilly’s closely watched Alzheimer’s drug

Bio Pharma Dive

The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.

Drugs 299
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March 5, 2024: Registration Opens for Pragmatic Trials Workshop at SCT 45th Annual Meeting

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will offer a preconference workshop at the 45th Annual Meeting of the Society for Clinical Trials in Boston. Registration for the workshop is now open. The workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on engaging stakeholders and

Trials 152
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Cheap Daily Supplement Seems to Boost Brain Function in Older Adults

AuroBlog - Aurous Healthcare Clinical Trials blog

What’s good for your aging gut may also be good for your aging brain. The first twin study of its kind suggests that taking daily protein and prebiotic supplements can improve scores on memory tests in people over the age of 60.

Protein 197
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AD/PD 2024: TauRx’s HMTM promising despite lacking primary endpoint data

Pharmaceutical Technology

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

Drugs 299
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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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Biden proposes strengthening Medicare’s drug pricing power

Bio Pharma Dive

The administration seeks to significantly increase the number of drugs each year that would be subjected to price negotiations under provisions of the Inflation Reduction Act.

Drugs 284
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Navigating Affordable Mental Health Services: A Guide to Accessing Support

Pharma Mirror

Presented by BetterHelp. Accessing affordable mental health services can significantly impact overall well-being. Learning how to connect with a therapist and access the kind of mental health care that you can afford can pave the way to a more satisfying and successful life. Even the WHO launched an initiative surrounding this issue in 2019. Launched in 2019, the WHO Special Initiative for Mental Health aims to ensure universal health coverage involving access to quality and affordable care for

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CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) and current […]

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The growing uses of medicinal cannabis

Pharmaceutical Technology

Demand for medicinal cannabis is increasing globally to treat a range of illnesses and conditions.

Medicine 340
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Alnylam, Roche blood pressure drug scores in second mid-stage trial

Bio Pharma Dive

The study results further validate Roche’s recent decision to acquire rights to the drug, which is being developed for people with a stubborn form of hypertension.

Drugs 294
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Exploring Online Resources for Health Education

Pharma Mirror

Presented by BetterHelp. With a veritable world of research and information in our pockets, the internet is a vast repository of knowledge. The online medical space offers valuable resources for individuals seeking to improve their health and well-being. From reputable websites to informative articles, online platforms provide accessible health education and empowerment avenues.

Research 130
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SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Johnson & Johnson acquires Ambrx Biopharma for $2bn

Pharmaceutical Technology

Johnson & Johnson (J&J) has concluded the acquisition of Ambrx Biopharma in a transaction valued at approximately $2bn.

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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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Bayer pays $310M to buy into BridgeBio heart drug

Bio Pharma Dive

The deal gives the German pharma partial rights to a closely watched medicine for transthyretin amyloidosis cardiomyopathy that analysts expect to become a multibillion-dollar product.

Drugs 286
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Navigating Mental Wellness: Understanding Neurodiversity and Self-Kindness

Pharma Mirror

Presented by BetterHelp. In the mental wellness space, neurodiversity can sometimes be overlooked. Although neurodivergent diagnoses differ from mental health concerns, there are often aspects of the diagnosis that can present mental health challenges for some people. For anyone diagnosed with a condition or disorder, self-esteem challenges can arise.

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Flashing Lights And a Clicking Sound Cleared Toxic Proteins in Alzheimer’s Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Could Alzheimer’s disease one day be treated by flashes of light and clicks of sound? Scientists have now demonstrated how stimulating high-frequency brain waves in mice can clear out the amyloid protein clumps associated with Alzheimer’s.

Protein 179
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BeiGene secures accelerated FDA approval for follicular lymphoma treatment

Pharmaceutical Technology

The FDA has already granted accelerated approvals to several third-line treatments, with big pharma being prominent in the landscape.

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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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NodThera says inflammation drug has positive effect in Parkinson’s

Bio Pharma Dive

The results from the privately held biotech add to early evidence supporting the potential of an increasingly popular drug target known as NLRP3 inflammasomes.

Drugs 286
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Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Worldwide Clinical Trials

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. One key decision is whether to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) or a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) and respective regulatory agencies of its member states.

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Unveiling the Power of Holistic Wellness: A Path to Better Sleep

Pharma Mirror

Presented by BetterHelp. Wellness is an important focus for most people. The concept of holistic wellness involves taking care of the mind and body. It can include conventional modern medicine, psychotherapy, and various activities to bring calm and balance to one’s life. The term ‘’mind, body, and spirit’’ is sometimes used to illustrate this holistic approach to health.

Medicine 130
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EMA awards double validation for Daiichi Sankyo and AstraZeneca’s cancer ADC

Pharmaceutical Technology

The EMA has validated the jointly developed TROP2-directed therapy for patients with breast or lung cancer following positive Phase III data.

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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.