Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Worldwide Clinical Trials

OCTOBER 19, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. But patient safety doesn’t stop being the priority when the session — or even the trial — ends.

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Drug Discovery World

NOVEMBER 24, 2023

The pivotal proof-of-concept testing clears the way to progress the Clamp2 technology in a range of research programmes. Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s widespread support for the project. “We

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pharmaphorum

MAY 26, 2022

Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.

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Clinical Trials Clinical Trials Trials Medicine 122

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

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Pharmaceutical Technology

APRIL 25, 2023

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinical trial.

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Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

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Clinical Trials Clinical Trials Trials Compliance 85

XTalks

JULY 6, 2022

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Rachel Colite, VP Decentralized Clinical Trials, Cogstate.

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Clinical Trials Clinical Trials Trials Licensing 98

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

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Pharmaceutical Technology

JULY 28, 2022

According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology. At the time points mentioned in the deal, the NDA will be transferred to Melinta. “We

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Pharmaceutical Technology

OCTOBER 4, 2022

In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology.

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Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

BioTech 365

JANUARY 10, 2022

Cellectis’ Licensed Partner, Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials Cellectis’ Licensed Partner, Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials • Allogene reported that Chromosomal Abnormality Was Not the Result of TALEN® … Continue reading →

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Clinical Trials Clinical Trials Licensing Licensing 40

Drug Discovery World

JANUARY 16, 2024

The Jenner Institute at the University of Oxford is conducting the study using Bacille Calmette-Guérin (BCG), the current licensed vaccine against TB. The post Clinical trial will test novel inhaled TB vaccine appeared first on Drug Discovery World (DDW).

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Clinical Trials Clinical Trials Vaccination Vaccine 59

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 78

Worldwide Clinical Trials

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities.

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Trials Clinical Trials Clinical Trials Licensing 243

XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g.

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Clinical Trials Clinical Trials Production Trials 104

XTalks

MAY 2, 2022

The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). A disease simulation model was created based on the results of the clinical trial and published literature to understand the long-term benefits of lecanemab use.

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Clinical Trials Clinical Trials Antibody Trials 98

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. •

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Clinical Trials Clinical Trials Trials Regulation 52

Cloudbyz

MAY 1, 2023

Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and account for all possible costs, including hidden ones, to ensure that the trial runs smoothly and within budget.

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Clinical Trials Clinical Trials Trials Packaging 52

BioTech 365

JANUARY 27, 2022

Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing (..)

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Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and (..)

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Drug Discovery World

JANUARY 31, 2024

Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress.

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Clinical Trials Clinical Trials Antibody Trials 52

BioTech 365

JANUARY 27, 2022

Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-Specific Revenue Forecasts – ResearchAndMarkets.com Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, (..)

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Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, (..)

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Clinical Trials Clinical Trials Licensing Licensing 40

pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.

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Gene Therapy Gene Licensing Licensing 106

Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Clinical Trials Clinical Trials Trials Licensing 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

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Velocity Clinical Research

AUGUST 18, 2023

She decided to focus on patient recruitment to promote diversity in clinical trial populations. Today, she’s Head of GP Engagement and Patient Recruitment for Velocity Clinical Research in the U.K. Through it all, her commitment to and belief in clinical research never wavered. Amira said, “ I have been in the U.K.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 17, 2021

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases.

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Clinical Trials Clinical Trials Trials Clinical Research 69

pharmaphorum

JANUARY 9, 2023

Swiss biotech Stalicla has continued to diversify its pipeline from a focus on autism therapies with a deal to license Novartis’ mavoglurant, in clinical trials for cocaine use disorder (CUD) as well as neurodevelopmental disorders (NDD). STP-2 was licensed from Evgen Pharma in October last year.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 30, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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Drug Discovery World

OCTOBER 11, 2023

Boehringer Ingelheim and CDR-Life entered a licensing agreement in May 2020 and announced the selection of an antibody fragment-based therapeutic candidate in September 2021.

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Clinical Trials Clinical Trials Antibody Trials 52

BioTech 365

JUNE 9, 2021

World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, Licensing and Acquisition, Revenue – ResearchAndMarkets.com World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, (..)

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