XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Production 64

Worldwide Clinical Trials

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. Rigorous procedures to ensure that drugs are effective and safe.

Clinical Trials 195

Clinical Trials Clinical Trials Drugs Trials 195

Worldwide Clinical Trials

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. ADRX-070 is the company’s lead candidate and is anticipated to enter a first-in-human Phase I clinical trial in the second half of 2023.

Clinical Development 147

Clinical Development Development Clinical Trials Clinical Trials 147

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2024

A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials.

Clinical Trials 81

Clinical Trials Clinical Trials Trials Production 81

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. These daunting figures highlight the necessity for innovative solutions that can accelerate the journey of new drugs from the lab to patients. Moreover, Dr. Clay mentions the economic benefits of digital measures.

Clinical Development 116

Clinical Development Development Clinical Trials Clinical Trials 116

Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. It’s very positive and it’s going to help move forward the pathway for new drugs.”

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

pharmaphorum

AUGUST 24, 2022

Diversity in clinical trials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinical trial participation for underserved groups is an essential part of addressing health inequalities. Clinical trial participation, she went on, was vital.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Development 111

BioPharma Reporter

DECEMBER 13, 2021

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

Antibody 143

Antibody Clinical Trials Clinical Trials Clinical Development 143

XTalks

MAY 19, 2023

Clinical trials play a vital role in advancing patient treatment and medical care. This article delves into ten trends and statistics in the world of clinical trials for 2023. Increasing Number of Registered Clinical Trials As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

Outsourcing Pharma

OCTOBER 10, 2024

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

Clinical Trials 90

Clinical Trials Clinical Trials Clinical Development Drugs 90

Pharmaceutical Technology

JULY 1, 2022

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally.

HR 264

HR Clinical Development Trials Vaccine 264

Worldwide Clinical Trials

JANUARY 24, 2024

Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. In my capstone, I focused on how, if, and when genetic counselors discuss clinical trials with their patients in the context of a counseling session.

Genetics 189

Genetics Trials Clinical Trials Clinical Trials 189

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 95

Clinical Trials Clinical Trials Regulation Trials 95

Worldwide Clinical Trials

NOVEMBER 21, 2023

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis.

Clinical Trials 195

Clinical Trials Clinical Trials Clinical Development Drugs 195

XTalks

DECEMBER 10, 2024

By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production. In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo.

Trials 104

Trials Protein Clinical Development Drugs 104

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

XTalks

JULY 29, 2024

Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history. Read on to learn key lessons in rare disease drug development.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Research 105

Pharmaceutical Technology

NOVEMBER 30, 2022

The latest development is based on data obtained from an open-label clinical trial of Biktarvy. According to the trial findings, the treatment was demonstrated to be effective and well-tolerated through 24 weeks in adolescents who are virologically suppressed and children with HIV infection.

Marketing 246

Marketing FDA Approval Clinical Trials Clinical Trials 246

XTalks

FEBRUARY 5, 2025

In this episode, Ayesha spoke with Mario Marcondes, MD, PhD, VP Head of Clinical Development at Nektar Therapeutics , a company focused on the discovery and development of novel therapies for autoimmune disorders and cancer. Dr. Marcondes is a licensed and trained physician, specializing in oncology and immune oncology.

Clinical Development 59

Clinical Development Development Life Science Clinical Trials 59

Worldwide Clinical Trials

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. An illustrative example of harmonization between agencies exists via the European Medicines Agency (EMA) and U.S.

Clinical Research 173

Clinical Research Trials Research Clinical Trials 173

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. At Worldwide, our early phase team has conducted these studies for over 20 years, gaining invaluable experience and insights into best practices for an AME study.

Clinical Trials 200

Clinical Trials Clinical Trials Pharmacy Trials 200

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

Pharmaceutical Technology

FEBRUARY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). Previously, the US FDA granted orphan drug designation to taldefgrobep to treat SMA, a rare and progressively debilitating motor neuron disease.

Clinical Trials 246

Clinical Trials Clinical Trials Genetics Protein 246

Outsourcing Pharma

OCTOBER 20, 2023

Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.

Clinical Trials 102

Clinical Trials Clinical Trials Trials Drugs 102

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

Antibody 130

Antibody Drugs Clinical Development Licensing 130

Pharmaceutical Technology

JANUARY 10, 2023

The transaction also includes a non-tradable contingent value right of $10 per share in cash which will be paid after a specified regulatory submission of CinCor’s lead drug candidate, baxdrostat (CIN-107). CinCor Pharma is focused on developing new treatments for chronic kidney disease and resistant and uncontrolled hypertension.

Clinical Trials 243

Clinical Trials Clinical Trials Clinical Development Development 243

XTalks

NOVEMBER 21, 2024

The drug also alleviated heart failure symptoms and improved patients’ physical limitations compared with placebo. Based on this data, Lilly said it plans a data submission to the US Food and Drug Administration (FDA) and other regulatory bodies before the end of the year. In contrast, only 29.7 billion.

Sales 105

Sales Insulin Drugs Trials 105

Pharmaceutical Technology

MAY 2, 2023

Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned.

Production 130

Production Drugs Clinical Trials Clinical Trials 130

Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

Clinical Trials 87

Clinical Trials Clinical Trials Trials Clinical Development 87

Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Worldwide Clinical Trials

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.

Trials 208

Trials Clinical Trials Clinical Trials Drugs 208

Pharmaceutical Technology

AUGUST 30, 2022

Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.

Development 130

Development Drugs Bioavailability Production 130