Drug Discovery World

JUNE 19, 2024

New research has uncovered how different people respond to sepsis based on their genetics, which could lead to the development of targeted therapies. The team from the Wellcome Sanger Institute, the University of Oxford, and collaborators built on their previous work that identified different subgroups of patients with sepsis. The new study, published in Cell Genomics , details the genetic basis of variability in sepsis response, and the different regulators and cell types involved in the differ

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Genetics Immune Response Genome Genomics 64

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 19, 2024

(Peter Dazeley/The Image Bank/Getty Images) Our body’s circadian clock affects everything from sleepiness to metabolism – and it might also influence how effective certain cancer treatments are, according to recent research.

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Scientist Protein Drugs Research 200

Pharmaceutical Technology

JUNE 19, 2024

IBI-343 is under clinical development by Innovent Biologics and currently in Phase I for Solid Tumor.

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Clinical Development Development 189

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 19, 2024

The Directorate General of Foreign Trade (DGFT), under the Union ministry of commerce & industry, has issued a directive addressing the issuance of Registration-Cum-Membership Certificate (RCMC) for medical devices.

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Clinical Trials Clinical Trials Clinical Research Trials 170

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Clinical Supply

Pharmaceutical Technology

JUNE 19, 2024

Polaroid Therapeutics’ CEO suggests that pharma should partner with medtech to prevent antibiotic resistance in wound management.

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BioSpace

JUNE 19, 2024

PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study.

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pharmaphorum

JUNE 19, 2024

An AI-powered blood test that may be able to predict Parkinson’s years before symptoms develop could allow earlier treatment and guide trials of new treatments

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Trials Development 119

Pharmaceutical Technology

JUNE 19, 2024

Nitronazine is under clinical development by Guangzhou Magpie Pharmaceutical and currently in Phase II for Amyotrophic Lateral Sclerosis.

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Clinical Development Development 130

BioSpace

JUNE 19, 2024

Vaxxinity published data from an early-stage clinical trial showing that its investigative immunotherapy, UB-312, could improve movement in Parkinson’s disease and protect against pathological alpha-synuclein.

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Protein Antibody Clinical Trials Clinical Trials 113

Pharmaceutical Technology

JUNE 19, 2024

Ascidian has entered a research partnership and licensing agreement with Roche to develop RNA therapies for neurological diseases.

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RNA Development Licensing Licensing 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

BioSpace

JUNE 19, 2024

Four executives with collective decades spent at BMS, Roche, Astellas, Eli Lilly and more gave their insights on navigating a biopharma career during a Monday DIA panel in San Diego.

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Pharmaceutical Technology

JUNE 19, 2024

Adakitug is under clinical development by Bristol-Myers Squibb and currently in Phase II for Hormone-Sensitive Prostate Cancer.

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Hormones Clinical Development Development 130

Drug Patent Watch

JUNE 19, 2024

In the ever-evolving pharmaceutical landscape, savvy businesses are constantly on the lookout for untapped markets and lucrative opportunities. One area that has garnered significant attention is the realm of low-competition generic drugs.

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Generic Drugs Drugs Manufacturing Marketing 110

Pharmaceutical Technology

JUNE 19, 2024

AbbVie has received FDA approval for SKYRIZI to treat adult patients with moderately to severely active ulcerative colitis.

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FDA Approval 130

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Clinical Supply

BioSpace

JUNE 19, 2024

A new observational study from the University of Iowa points to the potential of alpha-blocker drugs, commonly used to treat enlarged prostates, as a preventive therapeutic option for dementia with Lewy bodies.

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Drugs 107

Pharmaceutical Technology

JUNE 19, 2024

Abelacimab is under clinical development by Anthos Therapeutics and currently in Phase I for Venous (Vein) Thrombosis.

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Clinical Development Development 130

BioSpace

JUNE 19, 2024

Gilead Sciences reported zero cases of HIV infection occurred in the lenacapavir candidate group, compared to 16 cases in the Truvada arm and 39 incidents for those treated with Descovy, Gilead’s approved daily PrEP pills.

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Trials 106

Pharmaceutical Technology

JUNE 19, 2024

Unither Pharmaceuticals has announced a $106m investment to upgrade its Monroe County facility in New York, US.

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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

XTalks

JUNE 19, 2024

The US Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), has allocated $31.4 million to enhance behavioral health services for racial and ethnic minorities. This significant investment aligns with the government’s commitment to addressing mental health and the overdose crisis.

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Development 104

Pharmaceutical Technology

JUNE 19, 2024

Marea Therapeutics has launched with funding of $190m in a bid to develop cardiometabolic disease treatments.

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Development 130

Outsourcing Pharma

JUNE 19, 2024

During a panel discussion held at DIA Global in San Diego this week, which was moderated by Peter Wahl, industry experts delved into the integration of real-world (RW) data and advanced technologies to accelerate drug development.

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Clinical Trials Clinical Trials Development Drugs 100

Pharmaceutical Technology

JUNE 19, 2024

CEB-01 is under clinical development by Cebiotex and currently in Phase I for Pleomorphic Liposarcoma.

Clinical Development 130

Clinical Development Development 130

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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

BioSpace

JUNE 19, 2024

National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents.

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Drugs Research 99

Pharmaceutical Technology

JUNE 19, 2024

RNS-60 is under clinical development by Revalesio and currently in Phase II for Acute Ischemic Stroke.

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Clinical Development Development 130

Drug Discovery World

JUNE 19, 2024

KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, has been used to treat a 69-year-old patient suffering from treatment-refractory stiff-person syndrome (SPS). The therapy was given as part of a named-patient use in Germany for critically ill individuals who fail conventional therapies. SPS is a rare, progressive neurological autoimmune disorder causing debilitating muscle stiffness in the torso, arms, and legs, impacting the ability to walk or move.

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Production Trials Drugs 98

Pharmaceutical Technology

JUNE 19, 2024

CEB-01 is under clinical development by Cebiotex and currently in Phase I for Soft Tissue Sarcoma.

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Clinical Development Development 130

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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

pharmaphorum

JUNE 19, 2024

Improving maternity care is crucial, and healthtech innovations can play a significant role in enhancing maternal health outcomes. Explore how technology can revolutionise maternal care.

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Pharmaceutical Technology

JUNE 19, 2024

CEB-01 is under clinical development by Cebiotex and currently in Phase I for Nerve Sheath Tumor.

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Clinical Development Development 130

pharmaphorum

JUNE 19, 2024

Discover the importance of data in the process of commercialising drugs for rare diseases and how it plays a critical role in advancing treatment options for patients. Learn more about orphan diseases and drug development.

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Drugs Development 93

Pharmaceutical Technology

JUNE 19, 2024

SGNB-7H4V is under clinical development by Pfizer and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

Clinical Development 100

Clinical Development Development 100

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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