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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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. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

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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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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. Bio-Thera will handle BAT2206’s global development and commercial supply out of its manufacturing plants in Guangzhou, China.

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Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

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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 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. This post covers the key cost drivers for medical device clinical trials.

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pharmaphorum

JANUARY 18, 2022

Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. Vaccitech and the Ludwig Institute are providing the drug while the Centre manages the trial and provides funding.

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Pharmaceutical Technology

JULY 28, 2022

Rezafungin is a new, once-weekly echinocandin antifungal being developed by Cidara to treat and prevent serious fungal infections such as candidemia and invasive candidiasis in adults. It is also being developed for invasive fungal infection prophylaxis in adults who undergo allogeneic blood and marrow transplantation.

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Drug Discovery World

OCTOBER 11, 2023

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA).

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Pharmaceutical Technology

OCTOBER 4, 2022

Developed under joint research between Shionogi and Hokkaido University, the antiviral averts SARS-CoV-2 replication by hindering 3CL protease. In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease.

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Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials.

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Rethinking Clinical Trials

JULY 6, 2023

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

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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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Camargo

OCTOBER 15, 2020

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. If a single-arm trial was conducted as the pivotal trial for regulatory approval of those existing products, the sponsor will certainly want to do the same.

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Drug Discovery World

FEBRUARY 1, 2023

But more robust studies are needed across the board to help with the discovery and development of cannabis-based pharmaceuticals. Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace.

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Pharmaceutical Technology

APRIL 12, 2023

Panbela Therapeutics has regained the global rights for the development and commercialisation of Flynpovi (a combination of CPP-1X [eflornithine] and sulindac) to treat familial adenomatous polyposis (FAP) patients. The trial will also be designed to show the potential efficacy and safety of Flynpovi in the treatment of patients with FAP.

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Pharmaceutical Technology

AUGUST 4, 2022

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. 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.

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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

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

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pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. physIQ has a portfolio of FDA-cleared digital biomarkers and a medical-grade platform that can transform raw sensor data into clinical insight.

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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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WCG Clinical

JULY 11, 2023

Risk-based quality management (RBQM) isn’t something you merely add to an existing clinical trial. The basement is risk assessment, the ground floor is protocol development, and the top floor is the monitoring and quality assurance (QA) plan. That is what we really should be basing the foundation of all our clinical trials on.”

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Drug Discovery World

DECEMBER 7, 2023

A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. The post Potentially game-changing schizophrenia drug enters Phase I trials appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

JANUARY 9, 2023

Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials. The regulatory approval is based on the data obtained from the Phase II trial. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial.

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Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Eisai intends to conduct a Phase II clinical trial for BB-1701 in breast cancer.

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Delveinsight

SEPTEMBER 28, 2021

Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast , a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China. The drug was initially developed by LEO Pharma and acquired by UNION in 2020.

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XTalks

FEBRUARY 19, 2024

The study compared the immune responses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. However, the development of an effective vaccine that can target CMV infection has been extremely challenging.

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Camargo

MAY 10, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The members of the ODAC voted to continue the use of four of the six drugs it discussed during the meeting, despite failed clinical trials.

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STAT News

OCTOBER 12, 2022

Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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Pharmaceutical Technology

DECEMBER 2, 2022

The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC), supported Bharat Biotech in developing the new intranasal vaccine for Covid-19. Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinical trials of the vaccine.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.

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pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

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