Almirall licenses IL-21 antibody from Novo Nordisk
Pharmaceutical Technology
FEBRUARY 19, 2024
Almirall has signed a licensing agreement for the acquisition of worldwide rights to Novo Nordisk’s IL21-hindering antibody NN-8828.
Mon.Feb 19, 2024
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A Simple Blood Test Could Soon Predict Your Risk of Dementia
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 19, 2024
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.
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Risk adjusted net present value: What is the current valuation of Dyne Therapeutics’s DYNE-251?
Pharmaceutical Technology
FEBRUARY 19, 2024
DYNE-251 is an antisense oligonucleotide commercialized by Dyne Therapeutics, with a leading Phase II program in Duchenne Muscular Dystrophy.
February 19, 2024: Virtual Monitoring in Decentralized Trials, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
FEBRUARY 19, 2024
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.
PDS-01ADC by PDS Biotechnology for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
PDS-01ADC is under clinical development by PDS Biotechnology and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma).
Parliamentary Panel recommends increase in budget allocation for health sector
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 19, 2024
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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Roche’s Xolair is first medicine for food allergy in US
pharmaphorum
FEBRUARY 19, 2024
Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.
Yet another clinical hold for Gilead’s magrolimab trials
Pharmaceutical Technology
FEBRUARY 19, 2024
The US Food and Drug Administration (FDA) has requested a partial clinical hold on all solid tumour trials for Gilead's magrolimab.
Transforming clinical data management systems for biotechnology trials
pharmaphorum
FEBRUARY 19, 2024
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.
Celltrion’s Remsima SC for IBD gains approval in Canada
Pharmaceutical Technology
FEBRUARY 19, 2024
Celltrion has announced that its Remsima SC has obtained approval for use as maintenance therapy for inflammatory bowel disease (IBD).
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
AstraZeneca’s Tagrisso gets FDA approval, delaying lung disease progression by nine months
Outsourcing Pharma
FEBRUARY 19, 2024
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.
FDA approves AstraZeneca’s Tagrisso chemotherapy for NSCLC
Pharmaceutical Technology
FEBRUARY 19, 2024
The US FDA has granted approval for AstraZeneca's Tagrisso regimen for EGFRm non-small cell lung cancer (NSCLC) in adults.
Case Study: MGI and Alacris Theranostics
pharmaphorum
FEBRUARY 19, 2024
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.
Applied aims for approval post-Phase III win with SORD deficiency drug
Pharmaceutical Technology
FEBRUARY 19, 2024
Applied plans to submit a new drug application following the announcement of positive interim data from its Phase III trial.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Initiative by Innovative Trials to boost patient retention inspired by boy's love of collecting
BioPharma Reporter
FEBRUARY 19, 2024
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.
Daiichi Sankyo and AstraZeneca’s lung cancer antibody set for FDA review
Pharmaceutical Technology
FEBRUARY 19, 2024
An FDA approval in late 2024 would make it the first TROP2-directed therapy for NSCLC antibody drug conjugate patients.
New patent expiration for Sunovion Pharms drug LATUDA
Drug Patent Watch
FEBRUARY 19, 2024
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.
Pembrolizumab by Merck for Myxoid Liposarcoma: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
Pembrolizumab is under clinical development by Merck and currently in Phase II for Myxoid Liposarcoma.
The New Age of Decentralized Clinical Trials
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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.
Tagrisso-chemo cleared in US as 1st-line lung cancer therapy
pharmaphorum
FEBRUARY 19, 2024
AstraZeneca’s Tagrisso is cleared by FDA for use alongside chemotherapy as a frontline therapy for EGFR-positive lung cancer (NSCLC)
AC-0682 by Accutar Biotechnology for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
AC-0682 is under clinical development by Accutar Biotechnology and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).
How GoodRx Is Making Heart Health Medication Affordable
XTalks
FEBRUARY 19, 2024
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.
Tonmya by Tonix Pharmaceuticals Holding for Fibromyalgia (Fibromyalgia Syndrome): Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
Tonmya is under clinical development by Tonix Pharmaceuticals Holding and currently in Phase III for Fibromyalgia (Fibromyalgia Syndrome).
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
At risk patients with rare diseases need a higher level of support - and the process must change
Outsourcing Pharma
FEBRUARY 19, 2024
February will see the 16th annual Rare Disease Day which raises awareness of the more than 7,000 identified rare diseases worldwide.
AC-0176 by Accutar Biotechnology for Metastatic Castration-Resistant Prostate Cancer (mCRPC): Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
AC-0176 is under clinical development by Accutar Biotechnology and currently in Phase I for Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Silo Pharma's ketamine implant for fibromyalgia shows promise
BioPharma Reporter
FEBRUARY 19, 2024
Silo Pharmaâs dissolvable ketamine implant, initially targeting fibromyalgia and chronic pain, has seen success in early research.
S-365598 by ViiV Healthcare for Human Immunodeficiency Virus (HIV) Infections (AIDS): Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
S-365598 is under clinical development by ViiV Healthcare and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).
How Machine Learning Drives Clinical Trial Efficiency
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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.
Digital CBT reduced distress in patients with long-term physical health conditions
Pharma Times
FEBRUARY 19, 2024
Participants who received COMPASS showed a clinically significant improvement after 12 weeks
DZD-8586 by Dizal Pharmaceutical for Refractory Chronic Lymphocytic Leukemia (CLL): Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
DZD-8586 is under clinical development by Dizal Pharmaceutical and currently in Phase II for Refractory Chronic Lymphocytic Leukemia (CLL).
Predict-PD study to identify those at high risk of PD before symptoms appear
Pharma Times
FEBRUARY 19, 2024
The study aims to improve the representation of ethnic diversity within Parkinson’s research
Not Disclosed Neurodegeneration by Eli Lilly and Co for Neurodegenerative Diseases: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2024
Not Disclosed Neurodegeneration is under clinical development by Eli Lilly and Co and currently in Phase I for Neurodegenerative Diseases.
Accelerating Clinical Supply Through Integrated Drug Development
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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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