Drug Discovery World

JANUARY 23, 2024

Breast cancer was the most studied disease in 2023 for the third consecutive year, followed by solid tumours, stroke, Covid-19 and prostate cancer. The positive news is there has been an increase in trial recruitment across all the top five indications in 2023. Read the full report.

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Drug Discovery World

MARCH 15, 2024

Exploristics and Exonate have announced the completion of a successful collaboration to optimise the study design for Exonate’s upcoming Phase IIb study for diabetic eye disease. The collaboration has supported ongoing development of Exonate’s lead candidate, EXN407, following a recent successful Phase Ib/IIa study in November.

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Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment.

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Drug Discovery World

NOVEMBER 30, 2023

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. This suggests that FT011 may have a positive effect for scleroderma patients by reducing the inflammation and fibrosis associated with the disease.

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Drug Discovery World

FEBRUARY 10, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, despite a drop in activity, according to analysis from analytics company Phesi. However, the reduction in breast cancer trials is unexpected, with 113 fewer recruiting trials in 2022 compared with 2021.

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Drug Discovery World

OCTOBER 20, 2023

A new free service will offer insights in under ten days to sponsors conducting clinical trials, identifying potential ‘zombie trials’ and providing actionable recommendations for failing trials. The Health Check and Trial Rescue Service is an initiative of data software and services company Phesi.

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Drug Discovery World

OCTOBER 3, 2023

The US Food and Drug Administration (FDA) has announced a pilot programme with the aim of accelerating the development of novel drug and biological products for rare diseases. The post FDA pilot programme to boost rare disease therapies appeared first on Drug Discovery World (DDW).

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Drug Discovery World

AUGUST 22, 2023

Bloom Science has announced positive topline data from a Phase I clinical trial of BL-001 , a potential first-in-class therapeutic the company is developing for Dravet syndrome and amyotrophic lateral sclerosis (ALS). BL-001 shows promise as a novel treatment option that can change lives.

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Drug Discovery World

MARCH 8, 2024

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP).

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Drug Discovery World

NOVEMBER 23, 2023

Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. This will push the Phase III CALYX trial forward and bring leriglitazone to patients as quickly as possible,” said Sílvia Pascual, VP Clinical Development, Minoryx. “In

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Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. at 16 weeks and 76.2% at 52 weeks). .”

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Drug Discovery World

DECEMBER 22, 2022

Shelley McLendon , SVP of Vaccine and Infectious Diseases Program Management at ICON, attended the World Vaccine Congress Europe from 16-19 October 2022 in Barcelona, Spain. Disease surveillance and reporting . Disease surveillance is the collection and monitoring of data on disease within a population.

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Drug Discovery World

JULY 3, 2023

Janssen has announced positive results from the proof-of-concept Phase II UNITY trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN). The post Janssen reveals positive trial data for nipocalimab appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). month median overall survival (mOS) improvement, statistically significant mOS improvements between 4.2

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Drug Discovery World

JULY 12, 2024

Covid-19 is no longer in the top five most studied indications, replaced by type 2 diabetes, according to Phesi’s mid-year analysis of clinical trials. The analysis of 66,935 clinical trials reveals that the top five most studied diseases are now breast cancer, solid tumours, stroke, prostate cancer and type 2 diabetes.

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Drug Discovery World

JUNE 21, 2023

The company has stated its intention to schedule an end of Phase II meeting with the US Food and Drug Administration (FDA) to begin planning the next steps in the regulatory and clinical development programme for CITI-002. For the trial, Citius developed a PRO instrument to assess the efficacy of treatments in this disease.

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Drug Target Review

AUGUST 28, 2024

What are the main challenges currently faced in the treatment of chronic liver diseases, and how does Resolution Therapeutics aim to address these challenges? Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years.

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Drug Discovery World

SEPTEMBER 4, 2023

A new whitepaper has introduced the concept of ‘cross-over’ options in cancer clinical trials, as a way to make trials more patient-centric in design. It also encourages sponsors, investigators and regulators to advance patient-centric trial designs.

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Drug Discovery World

DECEMBER 7, 2022

Data analytics company Phesi analysed 2,358 clinical trials involving collagen. In the first 10 months of 2022, there were more than 225 new trials, compared with 125 in 2012. Phesi’s analysis shows that just 27% of trials received industry funding. In 2021, the global collagen market was valued at $9.75 billion by 2028.

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Cytel

MAY 14, 2024

Written by Angela Vinken and Patti Arsenault Key Opinion Leaders (KOLs) — i.e., trusted, well-respected experts — are crucial in clinical research, especially in rare diseases. Here, we discuss how KOLs can shape clinical trials, best practices for working with KOLs, and key considerations and potential challenges.

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Drug Discovery World

JULY 12, 2024

The US Food and Drug Administration (FDA) has granted Fast Track Designation for Asklepios BioPharmaceutical’s (AskBio) AB-1005 which is being developed for moderate Parkinson’s disease. AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy.

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Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Conversations in Drug Development Trends

MAY 14, 2024

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Common goals empower change.

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Drug Discovery World

JANUARY 6, 2023

ISA103 was developed using the company’s Synthetic Long Peptide (SLP) technology, designed to fully harness and direct the body’s defense mechanisms towards fighting the disease. In the two-part, open label Phase Ib/II trial, ISA103 will be tested in combination with standard of care checkpoint blocker immunotherapies.

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Drug Discovery World

OCTOBER 4, 2022

William Erhardt , President, Head of Development & Operations of biotech Oligomerix, tells Lu Rahman about the company’s differentiated approach to developing disease-modifying therapeutics for neurodegenerative diseases. . With its recent award of $3.35 Overcoming sector challenges .

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Drug Discovery World

FEBRUARY 27, 2024

The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease. VXX-401 is currently in a Phase I clinical trial for safety and tolerability, with topline data expected in mid-2024.

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Drug Discovery World

AUGUST 28, 2023

DDW’s Diana Spencer speaks to Peter Hamley , Chief Scientific Officer of Samsara Therapeutics, to understand the role autophagy plays in neurodegenerative diseases and how boosting this process could increase healthspan. DS: Samsara’s autophagy inducing candidate SAM001 will be the first agent of its class to enter clinical trials.

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Drug Discovery World

JUNE 26, 2024

Biotechnology company EG 427 has revealed plans to start a Phase Ib/IIa clinical study in neurogenic detrusor overactivity (NDO), following Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA). It is a step forward in bringing the potential benefits of gene therapy to large disease populations in neurology.

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Labcorp Drug Development

MARCH 7, 2023

The field of nephrology clinical research has been steadily adding new interventional trials over the last five years at an average pace of 176 trials per year. This activity reflects the … The post Enabling better access to kidney disease trials appeared first on Insights From Our Labs to Yours.

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Cytel

FEBRUARY 26, 2024

Adler, MPA, Director, Global Product Engagement, and Valeria Mazzanti, MPH, Associate Director, Customer Success In our previous post , we provided an overview of some of the challenges in studying rare disease therapies, as well as some of the statistical methods and design types that can be deployed to mitigate these challenges.

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Labcorp Drug Development

FEBRUARY 3, 2023

Welcome to the February 2023 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day?

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Drug Target Review

OCTOBER 11, 2023

Almost every one of us will know someone with a neurodegenerative disease such as Alzheimer’s or Parkinson’s. It is less common to know someone with a rare genetic disease; but while individually rare, collectively they have an enormous impact. This will, in turn, slow the progression of, or even halt, the disease.

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Drug Target Review

MAY 7, 2024

Why are biomarkers particularly critical in the context of rare diseases? Developing novel therapeutic approaches for rare diseases poses inherent challenges due to the limited populations available for testing. How do AI-enhanced approaches accelerate the drug development process for rare diseases?

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FDA Law Blog: Drug Discovery

JUNE 12, 2024

Sasinowski — Hyman, Phelps & McNamara (HPM) would like to congratulate the 7 rare disease programs selected for the inaugural class of the FDA’s “Support for clinical Trials Advancing Rare disease Treatment” (START) pilot program. HPM is proud to aid 5 of the 7 selected participants for the START pilot program.

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Drug Discovery World

JULY 21, 2023

Analysts Phesi revealed that a third of clinical development programmes are cancelled during Phase II, and there were significant trial results for drugs for head and neck cancer and Alzheimer’s disease. The most impactful drug discovery news this week is all linked with scientific research data.

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Conversations in Drug Development Trends

MAY 14, 2024

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Common goals empower change.

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