Drug Target Review

APRIL 30, 2025

In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. How AI is solving CGTs biggest challenges Cell and gene therapy is inherently complex. The result? Faster time-to-market and reduced costs.

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Drugs Therapies Clinical Trials Trials 90

PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. Accelerate your drug development and clinical trial goals and benefit from our 360° CDMO and CRO solutions and expertise.

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Drug Development Clinical Trials Drugs Small Molecule 97

Drug Target Review

JUNE 6, 2025

At the forefront of this transformation is Dr Ebrahim Delpassand, a nuclear medicine physician and the driving force behind RadioMedix (RMX), a radiopharmaceutical company focused on developing targeted diagnostics and therapies. The SPICA Center was built to address this gap.” GMP compliance is non-negotiable in this field.

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PPD

SEPTEMBER 16, 2024

Real-world data paired with machine learning is a game changer in drug development RWD is becoming increasingly important in influencing the drug development landscape, particularly when used to develop the natural history and patient journey through disease. AI has the potential to disrupt the entire clinical trial process.

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Clinical Development Clinical Trials Clinical Research Drug Development 98

PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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Clinical Development Clinical Trials Therapies Trials 98

SugarCone Biotech

JUNE 19, 2025

They have interesting patterns of expression in different cancer indications; thus, diverse therapies for attacking these targets have been developed. Each target and each therapeutic modality induce varying degrees of clinical efficacy, as well as causing toxicities. months (versus 20% ORR and 8.3

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Therapies Clinical Trials Treatment Clinical Development 78

SugarCone Biotech

MARCH 2, 2025

Bicara has focused ficerafusp alfa clinical development on head and neck squamous cell carcinoma (HNSCC), adding pembrolizumab to separately block the PD-1 pathway. Both EGFR inhibitors like cetuximab and PD-1 pathway inhibitors (pembrolizumab, nivolumab) induce responses in HNSSC.

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Therapies Clinical Trials Trials Clinical Development 67

PPD

OCTOBER 17, 2024

Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.

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Therapies Clinical Trials Clinical Research Trials 97

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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Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

Broad Institute

NOVEMBER 2, 2023

Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.

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Therapies Research Small Molecule Clinical Trials 105

The Pharma Data

JUNE 25, 2025

Novartis Finalizes Acquisition of Regulus Therapeutics, Strengthening Its Renal Disease Portfolio with Promising ADPKD Therapy Novartis AG, a leading global pharmaceutical company, has officially completed its acquisition of Regulus Therapeutics Inc. , a biotechnology firm known for its expertise in microRNA-targeting therapies.

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RNA Clinical Trials Disease Small Molecule 52

Drug Discovery Today

JANUARY 20, 2022

Cambridge and Wetherby, UK, 18 January 2022: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms announces that the next pre|CISION™ drug candidate, AVA3996, has been selected for pre-clinical development (..)

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Clinical Trials Clinical Development Drugs Therapies 113

Drug Target Review

JUNE 11, 2025

Drug development faces significant challenges: long timelines, high costs , complex processes and low probabilities of success (PoS), exacerbated by the shift towards more complex molecules, biologics and cell and gene therapies, hindering patient access to vital treatments. Highlighting data integration.

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Drugs Clinical Trials Drug Development Pharmaceuticals 64

PPD

MARCH 11, 2025

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

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Drug Development Clinical Trials Disease Trials 52

Drug Target Review

MAY 23, 2025

In the ever-evolving landscape of immuno-oncology, managing the side effects of advanced therapies has become just as important as enhancing their efficacy. Our goals are to progress our pipeline and position each asset for clinical and commercial success.

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Immune Response Therapies Treatment Clinical Trials 52

Drug Target Review

FEBRUARY 1, 2024

Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles. This can present challenges when attempting to recruit an enriched patient population for clinical trials. All stakeholders have benefited from these innovations.

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Therapies Drug Development Disease Clinical Development 104

PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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Trials Clinical Trials Clinical Development Clinical Research 98

Conversations in Drug Development Trends

JULY 3, 2025

Approximately two in 10 patients with hematologic malignancies are estimated to be eligible and able to receive cell therapy. The REMS Burden Explained Once deemed necessary for managing the risks associated with CAR T therapies, the REMS requirements imposed significant operational burdens on treatment centers.

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The Pharma Data

JUNE 22, 2025

The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C., The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.,

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Clinical Trials Therapies Treatment Trials 40

Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. Other therapeutic areas include cell and gene therapy. How do they stack up?

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Clinical Trials Trials Clinical Development Clinical Research 52

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

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Clinical Trials Trials Clinical Research Research 52

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Thus, these drugs best complement, rather than replace, healthy lifestyle interventions.

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Treatment Drugs Therapies FDA 130

Alta Sciences

FEBRUARY 19, 2025

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinical development, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.

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Drug Development Clinical Pharmacology Immune Response Drugs 52

The Pharma Data

JUNE 24, 2025

The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.

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Drug Development Clinical Trials Therapies Drugs 40

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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Clinical Development Drug Development Therapies Production 52

Labcorp Drug Development

JANUARY 17, 2023

Approaches to systemic anticancer therapy have shifted in recent decades. The potential of such immunotherapies to address untreatable malignancies … The post 4 emerging trends to watch in immunotherapy clinical trials appeared first on Insights From Our Labs to Yours.

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Clinical Trials Trials Therapies Clinical Development 52

The Pharma Data

JUNE 18, 2025

The investigational ADC is built using Daiichi Sankyo’s proprietary DXd technology and represents one of the newest generation of targeted cancer therapies. Building on Early Clinical Success The Phase 3 IDeate-Prostate01 trial is based on encouraging results from the earlier IDeate-PanTumor01 Phase 1/2 study.

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Trials Therapies Clinical Trials Treatment 40

PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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Clinical Development Clinical Trials Trials Drug Development 52

The Pharma Data

JUNE 22, 2025

Throughout the 26-week study period, the investigational therapy was well-tolerated. Additionally, no participants developed neutralizing antibodies to Mim8—a key concern with biological therapies that could undermine long-term efficacy.

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Pharmacokinetics Therapies Treatment Trials 40

The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

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Clinical Trials Trials Packaging Therapies 52

The Pharma Data

JUNE 25, 2025

Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapy developed by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.

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FDA FDA Approval Therapies Drugs 40

The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days.

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Clinical Development Therapies Clinical Trials Treatment 52

The Pharma Data

JUNE 24, 2025

Royalty Pharma and Revolution Medicines Forge $2 Billion Strategic Funding Pact to Accelerate Global Development of RAS Cancer Therapies Royalty Pharma plc, a prominent funder of innovation in the biopharmaceutical industry, announced a transformative agreement with Revolution Medicines, Inc.,

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Clinical Development Packaging Therapies Treatment 40

The Pharma Data

JULY 2, 2025

The decision follows an analysis of topline data from a Phase 1b clinical study, which demonstrated encouraging safety and efficacy results in patients with DOK7-CMS, one of the more severe and prevalent subtypes of this ultra-rare neuromuscular disorder. Peter Ulrichts, Ph.D., per 1 million. Source link

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Clinical Trials Trials Therapies Disease 40

Cytel

NOVEMBER 10, 2023

Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated sponsor liaisons. Characteristics of cell and gene therapy trials often require slightly different approaches to IDMC conduct in comparison to typical pivotal trials.

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Therapies Trials Clinical Trials Clinical Development 64

DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

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Drug Development Clinical Trials Drugs Therapies 98

The Pharma Data

JUNE 26, 2025

This unmet need has driven the development of alternative pharmacological options, including topical eye drops like MR-141, which aim to improve near vision through non-surgical means. Details of the VEGA-3 Phase 3 Trial The VEGA-3 study is part of Viatris’ broader clinical development program to evaluate MR-141 for presbyopia.

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Trials Clinical Trials Treatment Licensing 40