AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 6, 2023

Ever feel like everything hurts after not getting enough sleep? A new study reveals a neurotransmitter involved in the pain that sleep deprivation causes, indicating a potential new target for treatment. In sleep-deprived mouse models, the neurotransmitter N-arachidonoyl dopamine (NADA), an endocannabinoid, was reduced in one brain region linked to sensory processing and arousal.

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Clinical Trials Clinical Trials Trials 218

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in rAAV production technology for the pharmaceutical industry.

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Gene Therapy Production Gene 223

Bio Pharma Dive

NOVEMBER 6, 2023

Industry-leading cold storage manufacturers are engineering new solutions that can reliably meet performance benchmarks while consuming far less energy than yesterday’s ULT and laboratory-grade freezers.

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Engineer Manufacturing 139

Pharmaceutical Technology

NOVEMBER 6, 2023

Krazati received conditional marketing authorisation as a second-line treatment of KRAS-G12C mutated locally advanced or metastatic NSCLC.

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Marketing 162

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Clinical Supply

Bio Pharma Dive

NOVEMBER 6, 2023

A deal with Orum Therapeutics gives the large pharma access to an experimental blood and bone marrow cancer drug that's ready to enter clinical testing.

Drugs 148

Drugs 148

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 6, 2023

India’s smart doctor promoters are seeking help of professional healthcare management companies to introduce best healthcare management practices in their establishments, said Raj Sehgal associate director, TR Lifesciences. This is because these clinics encounter challenges even as there are growth prospects.

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Doctors Doctor Clinical Trials Clinical Trials 149

Pharmaceutical Technology

NOVEMBER 6, 2023

At AAO 2023, results were presented from the Phase III GALE trial, evaluating Apellis Pharmaceuticals’s Syfovre to treat geographic atrophy (GA).

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Trials 147

Bio Pharma Dive

NOVEMBER 6, 2023

Developing holistic treatment approaches that address patient needs today and in the future.

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Development 139

Pharmaceutical Technology

NOVEMBER 6, 2023

Trading under the ticker symbol ‘KRRO’, the new business’s initial focus is advancing an Alpha-1 antitrypsin deficiency candidate into trials.

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Trials 130

Rethinking Clinical Trials

NOVEMBER 6, 2023

Speaker Jonathan C. Moyer, PhD Statistician, NIH Office of Disease Prevention Moderator: Andrea J. Cook, PhD Senior Biostatistics Investigator, Kaiser Permanente Washington Health Research Institute Slides Keywords Individually randomized group treatments; Intervention; Randomization; Clinical trials Key Points In individually randomized trials (IRTs), individuals are randomized to either control or intervention arms.

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Trials Clinical Trials Clinical Trials Contamination 130

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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

Clinical Trials

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in microencapsulated peptide vaccines for the pharmaceutical industry.

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Vaccination Vaccine 130

Pharma Times

NOVEMBER 6, 2023

The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes

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Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in intracellular receptor modulators for the pharmaceutical industry.

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BioPharma Reporter

NOVEMBER 6, 2023

The UK has unveiled Â34.5 million ($42.8 million) in funding for four hubs dedicated to the development of vaccines for diseases with epidemic potential in low- and middle-income countries (LMICs).

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Vaccination Vaccine Development Regulation 111

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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

Clinical Research

Pharmaceutical Technology

NOVEMBER 6, 2023

Orum’s drug has an FDA clearance for the therapy to enter Phase I testing in AML and myelodysplastic syndromes.

Drugs 130

Drugs 130

Drug Patent Watch

NOVEMBER 6, 2023

A paper titled “Analysis of Strategy for Extending Patent Protection of Rucaparib” by Zhifeng Wang. discusses the strategies employed by pharmaceutical companies to extend the patent protection period of the… The post Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in pancreatic cell transplantation for the pharmaceutical industry.

Gene Therapy 130

Gene Therapy Gene 130

FDA Law Blog

NOVEMBER 6, 2023

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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Manufacturing Compliance Drugs Clinical Trials 105

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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.

Clinical Trials

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in personalized cancer vaccines for the pharmaceutical industry.

Vaccination 130

Vaccination Vaccine Medicine 130

BioSpace

NOVEMBER 6, 2023

For $80 million upfront and the promise of more than $1.2 billion in milestones, Novartis has bought the global rights to develop an oral HDAC6 inhibitor from Chong Kun Dang Pharmaceutical.

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Development 104

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in influenza vaccine vectors for the pharmaceutical industry.

Vaccination 130

Vaccination Vaccine 130

Fierce Pharma

NOVEMBER 6, 2023

History may repeat for Vertex Pharmaceuticals in the U.K., where a new decision by the country’s cost-effectiveness gatekeeper threatens to spark another dispute over the cost of lifesaving cystic | Last week, the U.K.'s National Institute for Health and Care Excellence unveiled draft guidance that acknowledged the effectiveness of Vertex’s cystic fibrosis drugs Trikafta, Symkevi and Orkambi.

Medicine 101

Medicine Drugs 101

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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.

Clinical Supply

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in synthetic COVID vaccines for the pharmaceutical industry.

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Vaccination Vaccine 130

Pharma Times

NOVEMBER 6, 2023

The image helps researchers understand how heart muscles operate in disease - News - PharmaTimes

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Research 128

Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in bacteriophage therapy for the pharmaceutical industry.

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130

Fierce Pharma

NOVEMBER 6, 2023

At the start of its first-ever conference call to present its quarterly numbers, Krystal Biotech CEO Krish Krishnan was quick to point out that the company’s positive earnings for the third quarter | Krystal Biotech's launch of Vyjuvek, the world's first topical gene therapy, has been so promising that analysts with Evercore ISI increased their 2024 sales projection to $273 million.

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Gene Therapy Sales Gene FDA Approval 97

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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.

Clinical Trials

Pharmaceutical Technology

NOVEMBER 6, 2023

AWT-020 is under clinical development by Anwita Biosciences and currently in Phase I for Lymphoma.

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Clinical Development Development 130

BioSpace

NOVEMBER 6, 2023

A combination of Gilead Sciences’ domvanalimab and Arcus Biosciences’ zimberelimab, along with chemo, has shown an “encouraging” overall response rate in a mid-stage study.

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Pharmaceutical Technology

NOVEMBER 6, 2023

GlobalData uncovers the leading innovators in oncolytic viruses for the pharmaceutical industry.

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130

Outsourcing Pharma

NOVEMBER 6, 2023

Life sciences investment group and part of global investment firm Carlyle, Abingworth announced last week it had exceeded its $300 million target by $56 million.

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Life Science Regulation Marketing 100

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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.

Clinical Supply