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). In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target.

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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

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

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. In 2021, the global collagen market was valued at $9.75 Phesi’s analysis shows that just 27% of trials received industry funding.

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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). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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Drug Discovery World

JULY 6, 2023

The first patient has been dosed in the clinical Phase I evaluation of the Sema3A monoclonal antibody, part of the Evotec-Bayer multi-target research collaboration in kidney diseases. Sema3A is upregulated in injured human kidneys and implicated in the development and progression of acute and chronic kidney diseases.

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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

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

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. Official comments .

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Drug Discovery World

JANUARY 23, 2024

The analysis of 65,749 recruiting clinical trials was conducted by data analytics company Phesi, as part of an annual global analysis of clinical trials using data from its Trial Accelerator platform. The positive news is there has been an increase in trial recruitment across all the top five indications in 2023.

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Drug Discovery World

JULY 12, 2024

Earlier this year, AskBio presented the 18-month Phase Ib clinical trial results for AB-1005 , which met its primary objective of evaluating the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.

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Cytel

APRIL 5, 2024

Written by Sydney Ringold, Customer Success Manager, and Kevin Trimm, Chief Product Officer In an ever-changing clinical development environment, sponsors face many challenges when designing clinical trials. Both options can be utilized to effectively design a trial, but which approach is best?

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PPD

JULY 6, 2023

It’s estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform. Surveys show that CROs improve trial efficiency and increase productivity.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

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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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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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H1 Blog

JUNE 7, 2023

Clinical trial success is a key factor for pharma companies when designing and recruiting patients into trials. This data can also provide guidance in terms of diversifying clinical trials to include different types of population demographics such as age, gender, race, ethnicity, or geographic location.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Drug Discovery World

MARCH 25, 2024

“By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development,” said Martin Holst Lange, Executive Vice President for Development at Novo Nordisk. “We

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Drug Discovery World

FEBRUARY 10, 2023

Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.

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Alta Sciences

MARCH 21, 2024

Top 5 Scientific Resources in CNS Clinical Trials blussier Thu, 03/21/2024 - 18:09 HTML CNS Center of Excellence Resource Library Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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Drug Discovery World

FEBRUARY 12, 2024

“In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. Without fixing the current, broken PV models, the continuous cycle of more complexity in the market, which then pushes organisations to incorporate automation into insufficient processes, will massively hinder PV operations.

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Drug Discovery World

APRIL 13, 2023

In 2018, the US Food and Drug Administration (FDA) introduced a policy for accepting real-world data (RWD) and real-world evidence (RWE) in addition to traditional clinical trial data in new drug applications. With RWD, fewer patients require direct enrolment in randomised clinical trials.

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Cytel

JANUARY 23, 2023

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

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Drug Discovery World

MARCH 7, 2024

The combined entity will operate as Akari Therapeutics, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX. Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages.

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Drug Discovery World

JUNE 16, 2023

The first-in-human Phase Ia trial for LP-184 is anticipated to launch and dose its first patient during the current quarter. LP-184 is the first of Lantern’s drug candidates to be developed entirely internally, with the assistance of Lantern’s AI and ML platform RADR, to advance to a first-in-human Phase Ia trial.

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Drug Discovery World

OCTOBER 3, 2023

The agency is inviting a limited number of sponsors to participate in the programme, which allows for more frequent communication with FDA staff to address clinical development issues. “We

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Drug Discovery World

JANUARY 25, 2024

Orphan Drug Designation is granted to medicines that treat or prevent life-threatening or chronically debilitating rare disease, and with either no currently approved method of prevention or treatment or with significant clinical benefit when compared with existing treatments. cases per 100,000 population, Globocan).

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The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. ” About Ascletis.

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Drug Discovery World

MAY 16, 2023

What opportunities and challenges are emerging and can therapies get to market faster? Moreover, he says that global supply chain pressures will continue into 2023, combined with instability in the financial markets that will make cost of goods high on his watchlist of risks to manage. DDW’s Megan Thomas finds out. The solution?

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Drug Discovery World

DECEMBER 20, 2022

The CHMP has recommended conditional marketing authorisation of CSL’s (etranacogene dezaparvovec), a one-time gene therapy for the treatment of appropriate adults with the disease. . The therapy was also recently approved by the FDA for patients in the US. . World’s most expensive drug.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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