XTalks

NOVEMBER 1, 2023

Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. She also spoke about clinical trials in the space, including Allergan Aesthetics’ commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard.

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Life Science Clinical Trials Clinical Trials Clinical Development 105

Pharma Mirror

JUNE 8, 2022

The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine. According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the.

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Clinical Trials Clinical Trials Trials Clinical Development 130

XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. Integrating DHTs Across Drug Development Phases Dr.

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Clinical Development Development Clinical Trials Clinical Trials 116

XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. Evolution in Oncology Clinical Trial Design Recent discussions at ESMO highlight a shift in how clinical trials are designed and conducted.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

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.”

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Clinical Development Development Clinical Trials Clinical Trials 110

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.

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Antibody Clinical Trials Clinical Trials Clinical Development 140

XTalks

OCTOBER 4, 2024

The push to increase diversity in clinical trials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Pharmaceutical Technology

JUNE 9, 2023

The therapy showed that it can inhibit the production of cytokine from both CD4+ T cells and ILC2, and completely suppressed skin allergic reactions in a monkey model in pre-clinical trials. Upstream Bio CEO Samantha Truex stated: “Our IND has been cleared by the FDA to pursue Phase II programmes in both asthma and CRSwNP.

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Clinical Development Development Life Science Clinical Trials 147

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.

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Genetics Trials Clinical Trials Clinical Trials 189

Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

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Immune Response Clinical Trials Clinical Trials Antibody 273

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?

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Clinical Trials Clinical Trials Trials Clinical Research 97

Outsourcing Pharma

MARCH 13, 2024

In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.

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Clinical Trials Clinical Trials Trials Clinical Development 92

Outsourcing Pharma

JANUARY 9, 2024

has announced a new intelligent automation technology applied across its clinical trials platform it hopes will cut standard trial build timelines by at least half. Medable Inc.

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Clinical Trials Clinical Trials Trials Clinical Development 102

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.

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Clinical Trials Clinical Trials Trials Research 105

Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Development 91

Pharmaceutical Technology

JULY 1, 2022

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. The safety data currently available for the therapy is in line with over 3,500 Paxlovid-treated subjects across the EPIC clinical development programme.

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HR Clinical Development Trials Vaccine 264

Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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Trials Clinical Trials Clinical Trials Clinical Development 189

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

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Clinical Trials Clinical Trials Pharmacy Trials 200

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.

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Clinical Trials Clinical Trials Regulation Trials 89

Pharmaceutical Technology

OCTOBER 14, 2022

It is currently being assessed in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for high-risk melanoma patients in a Phase II clinical trial being conducted by Moderna.

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Vaccination Vaccine Development Immune Response 289

ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.

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Clinical Trials Clinical Trials Trials Life Science 69

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.

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Gene Therapy Gene Trials Clinical Trials 264

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.

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Clinical Trials Clinical Trials Trials Drugs 97

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.

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Clinical Trials Clinical Trials Trials Production 64

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.

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Trials Clinical Trials Clinical Trials Development 242

Worldwide Clinical Trials

NOVEMBER 21, 2023

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. At Worldwide, we deliver full-service clinical development to support drug approval and commercialization.

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Clinical Trials Clinical Trials Clinical Development Drugs 195

Pharmaceutical Technology

NOVEMBER 21, 2022

At present, bomedemstat is being analysed in various Phase II clinical trials to treat myelofibrosis, essential thrombocythemia and polycythemia vera, apart from various other indications. The lead candidate of the company bomedemstat (IMG-7289) is an investigational, orally available inhibitor of lysine-specific demethylase 1 (LSD1).

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Clinical Trials Clinical Trials Clinical Development Sales 246

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.

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Clinical Trials Clinical Trials Clinical Development Drugs 84

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Production Clinical Development Development Regulation 69

Pharmaceutical Technology

NOVEMBER 28, 2022

According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinical trial. . on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.

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Development Gene Expression Licensing Licensing 264

Pharmaceutical Technology

FEBRUARY 22, 2023

Biohaven Clinical Development vice-president Lindsey Lee Lair said: “We are very pleased the FDA granted Fast Track designation for taldefgrobep alfa for the treatment of SMA. Currently, the company is enrolling participants in a Phase III clinical trial of taldefgrobep to treat SMA.

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Clinical Trials Clinical Trials Genetics Protein 246

Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Development 75

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.

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Marketing FDA Approval Clinical Trials Clinical Trials 246

XTalks

SEPTEMBER 25, 2024

Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, Clinical Trial Financial Management Medidata Alicia C.

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Clinical Trials Clinical Trials Trials Clinical Research 75

Pharmaceutical Technology

NOVEMBER 30, 2022

Of the 19 products currently in clinical development for PPMS (Figure 1), there are three novel agents deemed to be in late-stage development (late-stage Phase IIb and Phase III): AB Sciences’ masitinib, Sanofi’s tolebrutinib, and Roche’s fenebrutinib.

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Development Clinical Trials Clinical Trials Trials 246

Pharmaceutical Technology

JANUARY 10, 2023

It is currently in clinical development to treat hypertension and primary aldosteronism. Baxdrostat was found to reduce aldosterone levels significantly without affecting the levels of cortisol, across a broad dose range, in clinical trials.

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Clinical Trials Clinical Trials Clinical Development Development 243