Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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XTalks

FEBRUARY 9, 2023

Leading clinical trials technology platform provider Medable announced a new partnership with Nova Scotia Health Innovation Hub for a two-year pilot study to improve oncology trial access for patients in rural Nova Scotia through Medable’s decentralized clinical trial (DCT) platform.

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pharmaphorum

JANUARY 14, 2022

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.

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pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. How the NIHR’s Patient Engagement in Clinical Development service can help.

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Outsourcing Pharma

JANUARY 30, 2023

Canadian CRO Nutrasource Pharmaceutical and Nutraceutical Services Inc has rebranded its clinical trial site as Apex Trials to expand its focus beyond food & natural health product trials.

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Worldwide Clinical Trials

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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VirTrial

DECEMBER 8, 2023

If you missed Signant’s November 15 webinar about utilizing EDC for modern clinical trials, there is still time. Webinar Takeaways  With increasing decentralization in several aspects of trial , conduct, and management, are EDC systems still relevant? You can watch the  recorded webinar here  and below.

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XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Data security: The clinical trial data is backed-up and secure.

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BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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BioPharma Reporter

MARCH 17, 2021

Autolus Therapeutics is seeking a partner for clinical development of an ACE2 fusion soluble receptor decoy designed to work against SARS-CoV-2 and its variants.

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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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XTalks

OCTOBER 12, 2022

Magnetic resonance imaging (MRI) has had a part in clinical trials for more than three decades now. However, the role of MRI in new drug clinical trials can involve diagnosis of lesions and determination of their severity, early identification of therapeutic responders to drug treatment and treatment monitoring and follow-up.

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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.

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Outsourcing Pharma

AUGUST 13, 2020

The cloud-based study technology firm has secured Series B funding to help develop and promote products like its clinical trial platform, StudyTeam.

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Drug Discovery World

SEPTEMBER 12, 2022

We are hopefully nearing the tail-end of a pandemic that made the whole world become participants in that deep learning experience of what clinical development is. I think never before did we have families sit on the couch and talk about Phase I, II and III clinical trials. appeared first on Drug Discovery World (DDW).

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

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WCG Clinical

SEPTEMBER 11, 2023

Listen and Subscribe: Apple PodCASTs Spotify Google PoDCASTS About this episode: In episode three of WCG Talks Trials , two WCG experts discuss key findings from the 2023 Avoca State of the Industry Report , which provides a 360-degree view on motivators and deterrents to clinical trial participation.

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XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Pharmaceutical Technology

MAY 31, 2023

Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Outsourcing Pharma

MARCH 18, 2024

On Friday (March 15) leading pharma Auxilius Pharma announced promising results from the first-in-human clinical trial of its originative product-in-development, AUX-001.

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Cloudbyz

APRIL 12, 2022

Cloudbyz , makers of digital clinical research management solutions natively built and run on the Salesforce platform is headquartered in Naperville, Illinois. ClinChoice is committed to providing deep domain experience through reliable partnerships in support of clinical research trials around the world.

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The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. More information at www.algotx.com. View source version on businesswire.com: [link].

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Pharmaceutical Technology

AUGUST 26, 2022

PathAI has expanded a multi-year partnership agreement with Bristol Myers Squibb (BMS) to leverage artificial intelligence (AI)-powered pathology in translational research and clinical trials. The post PathAI expands AI-driven partnership with BMS appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

JUNE 2, 2023

China’s National Medical Products Administration (NMPA) has granted regulatory approval to Amarin’s commercial partner EddingPharm (EDDING) for Vascepa (icosapent ethyl). The agreement obligates Amarin to provide developmental support and supply the finished bulk product.

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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.

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Outsourcing Pharma

OCTOBER 8, 2020

eClinical, a provider of clinical data service solutions, has seen an increase in interest in clinical data platform and other digital products.

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Pharmaceutical Technology

MAY 31, 2023

BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. Disc focuses on discovering and developing new therapies for patients with serious haematologic ailments. Last year, Disc in-licensed bitopertin from Roche.

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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. In the U.S., 1 in 3 adults is at risk for the disease.

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Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

MAY 19, 2023

Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. The financing will help to fast-track the development of other in vivo programming candidates into clinical trials.

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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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Cloudbyz

MAY 4, 2022

NAPERVILLE, Ill. , May 4, 2022 /PRNewswire/– Cloudbyz , a fast-growing integrated clinical research and development solution provider with integrated capabilities, today announced that it has partnered with Tech Mahindra to provide integrated Clinical Trial Management Solutions. Media Contact: Grace Anderson Sr.

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Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. Roche and Poseida will also partner in a research programme for creating and developing next-generation features and enhancements for allogeneic CAR-T therapies.

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pharmaphorum

DECEMBER 7, 2020

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

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