Mon.Feb 19, 2024

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Almirall licenses IL-21 antibody from Novo Nordisk

Pharmaceutical Technology

Almirall has signed a licensing agreement for the acquisition of worldwide rights to Novo Nordisk’s IL21-hindering antibody NN-8828.

Licensing 241
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A Simple Blood Test Could Soon Predict Your Risk of Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

A detailed look at minute differences in the levels of specific proteins in blood has allowed researchers to identify potential early warning signs of dementia.

Protein 237
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Risk adjusted net present value: What is the current valuation of Dyne Therapeutics’s DYNE-251?

Pharmaceutical Technology

DYNE-251 is an antisense oligonucleotide commercialized by Dyne Therapeutics, with a leading Phase II program in Duchenne Muscular Dystrophy.

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Parliamentary Panel recommends increase in budget allocation for health sector

AuroBlog - Aurous Healthcare Clinical Trials blog

Even as the interim budget for the fiscal year 2024-25 has projected an outlay of Rs. 90,171 crore for health sector as against the Budget Estimates of Rs.

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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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February 19, 2024: Virtual Monitoring in Decentralized Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine.

Trials 140
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Pembrolizumab by Merck for Myxoid Liposarcoma: Likelihood of Approval

Pharmaceutical Technology

Pembrolizumab is under clinical development by Merck and currently in Phase II for Myxoid Liposarcoma.

More Trending

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Applied aims for approval post-Phase III win with SORD deficiency drug 

Pharmaceutical Technology

Applied plans to submit a new drug application following the announcement of positive interim data from its Phase III trial.

Drugs 130
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Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

pharmaphorum

AstraZeneca’s Tagrisso is cleared by FDA for use alongside chemotherapy as a frontline therapy for EGFR-positive lung cancer (NSCLC)

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Daiichi Sankyo and AstraZeneca’s lung cancer antibody set for FDA review

Pharmaceutical Technology

An FDA approval in late 2024 would make it the first TROP2-directed therapy for NSCLC antibody drug conjugate patients.

Antibody 130
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Digital CBT reduced distress in patients with long-term physical health conditions

Pharma Times

Participants who received COMPASS showed a clinically significant improvement after 12 weeks

Research 124
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Yet another clinical hold for Gilead’s magrolimab trials

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has requested a partial clinical hold on all solid tumour trials for Gilead's magrolimab.

Trials 130
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Transforming clinical data management systems for biotechnology trials

pharmaphorum

Learn how biotechnology trials are transforming clinical data management systems, leveraging machine learning and advanced protocols to enhance efficiency and accuracy in data collection and analysis.

Trials 124
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FDA approves AstraZeneca’s Tagrisso chemotherapy for NSCLC

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's Tagrisso regimen for EGFRm non-small cell lung cancer (NSCLC) in adults.

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Predict-PD study to identify those at high risk of PD before symptoms appear

Pharma Times

The study aims to improve the representation of ethnic diversity within Parkinson’s research

Research 117
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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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Iovance’s Amtagvi for melanoma treatment gains FDA approval

Pharmaceutical Technology

Iovance Biotherapeutics' Amtagvi has received accelerated US FDA approval for treating adults with metastatic or unresectable melanoma.

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Case Study: MGI and Alacris Theranostics

pharmaphorum

This case study explores the collaborative efforts of MGI and Alacris Theranostics in utilising molecular tumour profiling technology for advanced research. Discover the impact of this innovative approach on personalised medicine and treatment strategies.

Medicine 116
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Tonmya by Tonix Pharmaceuticals Holding for Fibromyalgia (Fibromyalgia Syndrome): Likelihood of Approval

Pharmaceutical Technology

Tonmya is under clinical development by Tonix Pharmaceuticals Holding and currently in Phase III for Fibromyalgia (Fibromyalgia Syndrome).

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At risk patients with rare diseases need a higher level of support - and the process must change

Outsourcing Pharma

February will see the 16th annual Rare Disease Day which raises awareness of the more than 7,000 identified rare diseases worldwide.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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New patent expiration for Sunovion Pharms drug LATUDA

Drug Patent Watch

Annual Drug Patent Expirations for LATUDA Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are nine… The post New patent expiration for Sunovion Pharms drug LATUDA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 102
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Risk adjusted net present value: What is the current valuation of Ikena Oncology’s IK-595?

Pharmaceutical Technology

IK-595 is a small molecule commercialized by Ikena Oncology, with a leading Phase I program in Solid Tumor.

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Silo Pharma's ketamine implant for fibromyalgia shows promise

BioPharma Reporter

Silo Pharmaâs dissolvable ketamine implant, initially targeting fibromyalgia and chronic pain, has seen success in early research.

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Risk adjusted net present value: What is the current valuation of Eli Lilly and Co’s DC-806?

Pharmaceutical Technology

DC-806 is a small molecule commercialized by Eli Lilly and Co, with a leading Phase II program in Plaque Psoriasis (Psoriasis Vulgaris).

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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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How GoodRx Is Making Heart Health Medication Affordable

XTalks

GoodRx , a leading prescription savings platform, has launched a significant initiative to tackle cardiovascular disease in the US. The company now offers 30 key heart health medications for under $30 at more than 70,000 pharmacies nationwide. This effort marks a significant advancement in making healthcare more affordable and accessible, particularly for the nearly half of US adults dealing with conditions like coronary artery disease, high cholesterol and hypertension.

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Risk adjusted net present value: What is the current valuation of Nuvalent’s NVL-655?

Pharmaceutical Technology

NVL-655 is a small molecule commercialized by Nuvalent, with a leading Phase II program in Non-Small Cell Lung Cancer.

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Initiative by Innovative Trials to boost patient retention inspired by boy's love of collecting

BioPharma Reporter

The father of a boy diagnosed with acute lymphoblastic leukemia at the age of nine, inspired by his son's love of collecting, has created patches of positivity for children going through cancer treatment to collect.

Trials 88
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Risk adjusted net present value: What is the current valuation of Nuvalent’s NVL-520?

Pharmaceutical Technology

NVL-520 is a small molecule commercialized by Nuvalent, with a leading Phase II program in Non-Small Cell Lung Cancer.

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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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AstraZeneca’s Tagrisso gets FDA approval, delaying lung disease progression by nine months

Outsourcing Pharma

Patients in the US with epidermal growth factor receptor mutated (EGFRm) advanced lung cancer can now receive an important new treatment option delaying disease progression by nearly nine additional months.

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Risk adjusted net present value: What is the current valuation of RegenxBio’s RGX-202?

Pharmaceutical Technology

RGX-202 is a gene therapy commercialized by RegenxBio, with a leading Phase II program in Duchenne Muscular Dystrophy.

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AZ, Daiichi eye December verdict for TROP2 ADC

pharmaphorum

FDA sets December date for decision on AstraZeneca and Daiichi Sankyo’s TROP2-directed ADC Dato-DXd as a therapy for lung cancer (NSCLC)

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Risk adjusted net present value: What is the current valuation of Praxis Precision Medicines’s PRAX-628?

Pharmaceutical Technology

PRAX-628 is a small molecule commercialized by Praxis Precision Medicines, with a leading Phase II program in Epilepsy.

Medicine 100
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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.