Cytel

JANUARY 15, 2024

After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen challenging market dynamics and a drop-off in activity. Every one of us working in clinical development has felt this slowdown, but as we begin 2024, there is reason for optimism.

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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

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

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations.

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Drug Discovery World

MARCH 15, 2024

“We are excited to begin the next phase of development with the initiation of two 28-day patient studies, the first studies of ALX-001 in people living with Alzheimer’s and Parkinson’s disease,” commented Tim Siegert, Chief Operating Officer and Co-Founder of Allyx Therapeutics. “We

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Drug Discovery World

MAY 17, 2023

Leveraging historical trial databases has become commonplace in assessing the feasibility of trials in therapeutic areas with a large breadth of clinical development history. EHR data also has a key role to play in designing future clinical trials.

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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 30, 2023

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. It is important to advance safe and effective treatments through clinical development, given the limited therapeutic options for scleroderma patients.

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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

JANUARY 17, 2023

In this latest episode, DDW’s Megan Thomas is in conversation with two experts when it comes to clinical trials. Walz was recently selected in the 2022 PharmaVoice 100 for the company’s innovative work in the space, and speaks about how real world data can help to boost diversity rates in clinical trials.

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Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. Chief Investigator Dr Bristi Basu, University of Cambridge, and Co-Chief Investigator Dr Debashis Sarker, King’s College London, are leading the trial.

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Drug Discovery World

JANUARY 17, 2023

In this latest episode, DDW’s Megan Thomas is in conversation with two experts when it comes to clinical trials. Walz was recently selected in the 2022 PharmaVoice 100 for the company’s innovative work in the space, and speaks about how real world data can help to boost diversity rates in clinical trials.

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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

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

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 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

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

JULY 27, 2023

Immuno-oncology company Crescendo Biologics has revealed plans to augment the ongoing Phase Ib clinical trial of CB307 through the addition of a new pembrolizumab (anti-PD-1) combination expansion cohort. CB307, Crescendo’s lead proprietary programme, is now entering the cohort expansion part of the ongoing Phase Ib clinical trial.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Drug Discovery World

MARCH 13, 2023

LEO Pharma and ICON have formed a strategic partnership that will enable LEO to offer clinical trials within medical dermatology that are patient-centric and cost effective. The partnership will operate under the acronym of PACE, reflecting the requirement to move quickly to address today’s clinical development challenges.

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Cytel

AUGUST 28, 2023

A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drug development and helps ensure that new therapies are safe, effective, and of high quality.

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Cytel

MARCH 11, 2024

In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising non-oncology rare diseases. Clinical development in rare diseases has specific challenges. Effective clinical development strategy for rare diseases requires agility to adapt to accumulating learning.

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Drug Discovery World

MARCH 24, 2023

This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month 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).

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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

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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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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Drug Discovery World

OCTOBER 18, 2022

A working group has been created to measure and compare the carbon footprint of centralised (traditional site-based) and decentralised clinical trials. The Clinical Trials Environmental Impact Community of Interest (CoI) was started by Pistoia Alliance member, Syneos Health. Growing pressure on life sciences.

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Drug Discovery World

JULY 6, 2023

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are excited that Bayer is moving ahead with the Phase I clinical development of an asset from our multi-target research alliance in kidney diseases. The post First patient dosed in trial of antibody for kidney disease appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JANUARY 30, 2023

Dominic Elliston , Managing Director of Evoke Galliard and Evoke Incisive Health, shares his take on how effective clinical trial communications is the key to expediting the delivery of new and extraordinary treatments. What’s that got to do with clinical trials? Tell us about yourself, Dominic.

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Drug Discovery World

JANUARY 6, 2023

Cancer Focus Fund is committed to using its investments to support the clinical development of truly innovative cancer therapies,” said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. A total of 90 patients will be enrolled in the trial. .

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Drug Discovery World

SEPTEMBER 12, 2022

We are hopefully nearing the tail-end of a pandemic that made the whole world become participants in that deep learning experience of what clinical development is. I think never before did we have families sit on the couch and talk about Phase I, II and III clinical trials. appeared first on Drug Discovery World (DDW).

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Cytel

JANUARY 13, 2023

Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase clinical trials. Yet there are also many strategic uses of Bayesian methods in late-phase clinical trial design, which can help generate more effective, efficient, and ethical clinical trials.

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Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. February 2022.

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Cytel

NOVEMBER 8, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director, Blackstone Life Sciences When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities.

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Cytel

JANUARY 17, 2024

Despite accumulating learnings from early phases, several uncertainties remain to be addressed when designing pivotal trials. Adaptive trials can help mitigate uncertainties; however, the trade-offs and their impact differ in the confirmatory setting. Quantitative strategies can help inform decisions and optimize choices.

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Drug Discovery World

MARCH 10, 2023

Cancer Research UK and UCB have agreed a clinical development collaboration to advance two of UCB’s investigational oncology antibody candidates through clinical trials. If successful in clinical trials the investigational candidates may have the potential to offer cancer patients access to new targeted treatment options.

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