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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Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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pharmaphorum

OCTOBER 19, 2022

Yesterday, global provider of patient-centric data analytics, Phesi launched its AI-driven Trial Accelerator Platform, an integrated SaaS solution designed to enable clinical development personnel to leverage study and control arm data, so as to accelerate product development.

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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

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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ACRP blog

JULY 26, 2022

“Everything we do in clinical trials is based on statistical principles, and you have to be comfortable with” them to flourish as a clinical trial professional, says Joy Frestedt, PhD, RAC, FRAPS, CPI, FACRP, president and CEO of Frestedt Incorporated and Alimentix, the Minnesota Diet Research Center.

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Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.

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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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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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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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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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Pharmaceutical Technology

MAY 9, 2023

FOR46 is currently being investigated in a Phase I trial as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC). The trial is also studying the capability of FOR46 for use in other CD46-expressing cancers. FOR46 is a natural fit with our research and development capabilities and expertise.

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Pharmaceutical Technology

APRIL 3, 2023

The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China. It is based on RayzeBio’s specialisation in targeted radiotherapy (TRT) discovery and Ablaze’s know-how in therapeutic product clinical development, as well as on the radiopharmaceutical infrastructure in China.

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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

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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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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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.

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Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. Chief Investigator Dr Bristi Basu, University of Cambridge, and Co-Chief Investigator Dr Debashis Sarker, King’s College London, are leading the trial.

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XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

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Pharmaceutical Technology

FEBRUARY 8, 2023

Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science. Since 2016, the facility has been manufacturing lentiviral vectors (LVV) and drug product for the ongoing programmes of Genenta.

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Pharmaceutical Technology

JUNE 13, 2023

ViXome is an acellular product derived from amniotic fluid. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects. The company stated that the Phase I/IIa trial will thoroughly evaluate the therapy’s clinical efficacy and safety.

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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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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

DECEMBER 17, 2020

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

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The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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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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pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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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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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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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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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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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

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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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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Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Outsourcing Pharma

JUNE 8, 2023

A cannabinoid receptor, that has shown potential as an effective treatment for chemotherapy induced peripheral neuropathy (CIPN) has been given approval for a phase 1 clinical trial by the Medicines and Healthcare Products Regulatory Agency (MRHA) and The Wales Research Ethics Committee 2 (REC 2).

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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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