The Pharma Data

JANUARY 24, 2021

25, 2021 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Technologies developed by Therapeutic Solutions International allow for the manufacture of unique dendritic cells from cord blood stem cells, which can be used in a universal donor manner. . OCEANSIDE, Calif., Source link.

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International Laboratories Therapies Treatment 40

Drug Target Review

DECEMBER 28, 2023

In most cancers, the tumour evolves by acquiring mutations that confer growth advantages or resistance to therapies. However, if the therapy targets only the subclonal (branch) mutations, this will result in the mere ‘pruning’ of specific branches rather than elimination of the whole cancer.

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Bioinformatics Immune Response DNA Vaccine 105

The Pharma Data

JANUARY 27, 2021

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). CAMBRIDGE, Mass. ROTTERDAM, Netherlands and SUZHOU, China , Jan. ” he added.

Therapies 40

Therapies Treatment International Licensing 40

Drug Target Review

OCTOBER 1, 2024

Indeed, I’m afraid to say I experienced some biases regarding my lack of experience when I joined my first company, especially from non-medical colleagues who saw me as an internal competitor. That paper, of which I was in the authorship, remains a current point of reference for that therapy usage.

Doctors 97

Doctors Therapies Science Pharma Companies 97

The Pharma Data

JUNE 7, 2023

Bayer strengthens gene therapy portfolio with lipid nanoparticle technology from Acuitas Therapeutics Bayer AG is joining forces with Acuitas Therapeutics, Inc., a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics.

Therapies 40

Therapies RNA Licensing Licensing 40

The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly. About EMPEROR-Preserved.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

LifeSciVC

APRIL 2, 2024

And the experience of those around you, including Board members and internal investors. We are confident that there is room for improvement over existing cystic fibrosis (CF) therapies because we have not yet achieved fully normalized function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Science 67

Science Small Molecule International Clinical Development 67

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease).

Small Molecule 138

Small Molecule Trials Therapies Disease 138

The Pharma Data

MARCH 9, 2021

New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021. vice president of Alzheimer’s disease development unit, Eli Lilly and Company.

Disease 40

Disease International Research Therapies 40

PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. 2) An established FSO arrangement is to be replaced, and the developer needs to transition to FSP without disrupting momentum.

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Clinical Trials Clinical Development Trials International 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

Drug Target Review

APRIL 9, 2024

Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy. These compounds were later licensed to the pharmaceutical industry for clinical development.

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RNA Cell Biology Clinical Development DNA 64

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

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Drug Development Clinical Trials Drugs Clinical Research 98

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. BioInvent International AB (publ).

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

APRIL 27, 2022

“We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”.

Treatment 52

Treatment Clinical Development Therapies Clinical Trials 52

Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

The Pharma Data

JANUARY 20, 2021

Dr. Rouleau has an international reputation in cardiovascular research, particularly in the field of both basic mechanisms and improving the clinical care of patients with heart failure. His publication list includes more than 475 articles and 7 book chapters. About Cardiol Therapeutics. Cardiol Therapeutics Inc. (

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Hospitals Trials International Clinical Trials 52

PPD

OCTOBER 2, 2024

To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

The Pharma Data

SEPTEMBER 6, 2021

Currently, no treatment is approved for the therapy of RCC, and the medical need for new effective treatments is high. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinical development strategy of eliapixant.”.

Trials 52

Trials Clinical Trials Treatment International 52

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g.,

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Production Small Molecule Regulations Trials 114

The Pharma Data

JANUARY 27, 2021

.–( BUSINESS WIRE )– PlateletBio , a pioneering biotechnology company developing next-generation allogeneic cell therapies for treatment of human diseases, has named Steven M. A recognized gene and cell therapy expert, Dr. Altschuler co-founded Spark Therapeutics, taking it from launch to its $4B acquisition by Roche.

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Therapies Clinical Development Engineering Disease 40

The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S.

Disease 52

Disease FDA Treatment Clinical Trials 52

Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Diseased cells are likely to be more fragile or less abundant, making it difficult to obtain enough for therapy.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

The Pharma Data

JANUARY 27, 2021

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. This demands synchronization between sponsor training protocols and internal resource management. Here’s how we do it.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

The Pharma Data

DECEMBER 13, 2020

CEO of EdiGene, “Translating cutting-edge gene editing technologies into innovative solutions for patients requires deep internal R&D expertise as well as strong external partnerships. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. He received his B.S.

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Medical Schools Clinical Development Therapies RNA 40

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. Proposals to the Nomination Committee can be sent to Stefan Ericsson , by mail: BioInvent International AB (publ).), BioInvent International AB (publ).

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Clinical Trials Licensing Licensing International 40

The Pharma Data

JANUARY 19, 2021

The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is based in Suzhou and Shanghai, China.

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Small Molecule Trials Laboratories Immune Response 52

Vial

MARCH 25, 2024

Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members. Other therapeutic areas include cell and gene therapy.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies 52

Therapies Trials Disease Treatment 52

PPD

DECEMBER 14, 2023

In an increasingly competitive clinical trial and post-marketing surveillance sphere, many companies have turned to outsourcing models to rapidly expand their capabilities, more efficiently leverage internal resources and reach a broader population of trial participants and research personnel.

Clinical Development 52

Clinical Development Clinical Trials International Trials 52

The Pharma Data

JANUARY 14, 2021

Nutt stated, “I am pleased with what is an exciting opportunity to conduct regulatory-level trials that I hope will turn our discovery of MDMA as a treatment for alcoholism into a clinical therapy.” Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide.

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Science Treatment Clinical Trials Clinical Development 52

The Pharma Data

JULY 22, 2021

This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company,” said John Houston, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer.

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Targeted Protein Degradation Therapies Clinical Trials Treatment 52

The Pharma Data

OCTOBER 18, 2020

Berk, commented “I am excited to join the Board of Inflection Biosciences as it advances its novel PIM/PI3K inhibitor, IBL-202, towards clinical development for unmet needs in B-cell malignancies and other cancers.”. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies.

Small Molecule 40

Small Molecule Clinical Development Clinical Trials Licensing 40

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. based Rinri Therapeutics.

Small Molecule 52

Small Molecule Clinical Development Engineering Pharmaceuticals 52

Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7 This means study startup times can vary greatly.

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

PPD

MAY 7, 2024

This harmonization aims to enhance the efficient use of resources, reduce duplication in HTA submissions and address inequities in patient access to innovative therapies. Early scientific advice, either formal or informal, can shape pivotal study design early in the development process.

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