Drug Discovery World

MAY 6, 2024

Even before this, however, Amsterdam was established as an important centre for drug development. A more established Amsterdam-based enterprise is gene therapy company uniQure, developer of etranacogene dezaparvovec, the first gene therapy for haemophilia B, which was approved for use in the US in November 2022 and in the EU in February 2023.

Drugs 147

Drugs Molecular Biology Science Clinical Trials 147

Drug Discovery World

JULY 13, 2022

Novo Nordisk presented interim results from the Phase I & II FRONTIER1 dose-escalation study at International Society of Thrombosis and Haemostasis Annual Congress (ISTH 2022) in London, UK.?? . The study is assessing the safety and clinical use of Mim8 in patients with haemophilia A. Official comments .

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International Clinical Trials Clinical Development Therapies 130

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Therapies FDA Production Regulations 59

Drug Discovery World

SEPTEMBER 14, 2023

Evaluating Immatics’ IMA203 TCR-T therapy, targeting PRAME, in combination with Moderna’s PRAME mRNA-based cancer vaccine. Moderna will lead the clinical development and commercialisation of cancer vaccines and TCER therapeutics resulting from the collaboration.

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Vaccine Bioinformatics Clinical Trials Therapies 130

Drug Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide.

Therapies 130

Therapies Compliance Production International 130

Drug Discovery World

SEPTEMBER 12, 2022

If anything, this period has been a reminder that people are the primary reason we do what we do, and the Patient Access, Healthcare & People track at Advanced Therapies Europe 2022 allowed DDW’s Multimedia Editor Megan Thomas to share several reflections on the topic. .

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Drug Discovery World

MAY 29, 2024

When the science lines up, execution of BD goals can enable time-appropriate returns to investors, lengthen the runway (time to cash out), and expand the reach of core technologies beyond programs that can be carried out internally. For pharmas, new programs and portfolios from biotech companies offer a way to augment internal research.

International 147

International Licensing Licensing Regulations 147

Drug Discovery World

JUNE 15, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. Here, attendees weigh in on future regulatory changes.

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Drug Discovery World

JUNE 29, 2023

David Favre, Chief Development Officer, SpliceBio Dr Favre brings more than 25 years of experience in gene therapy, immunology and drug development throughout academia and the biopharma industry. It’s been another busy month for senior appointments in the drug discovery sector.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

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Drug Discovery World

JULY 2, 2024

An internal study performed recently, highlighted how Basel is outstanding in scientific collaboration with industry, measured via joint publications and at the same time how the local industry excels globally in the number of patents filed.” Three years ago, we started our venture into the radiotherapy space.

Science 147

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Drug Discovery World

OCTOBER 5, 2022

Biotechnology company Complement Therapeutics (CTx) has formed a Clinical & Scientific Advisory Board to help accelerate the development of its pipeline of therapeutics targeting complement-mediated diseases. The company hopes to evaluate CTx001 in other complement-mediated conditions. Official comments.

Clinical Development 130

Clinical Development Hospitals International Therapies 130

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

Drug Discovery World

JUNE 16, 2023

LP-184 is the first of Lantern’s drug candidates to be developed entirely internally, with the assistance of Lantern’s AI and ML platform RADR, to advance to a first-in-human Phase Ia trial.

FDA 130

FDA Clinical Trials Drugs DNA 130

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.

International 52

International Laboratories Therapies Clinical Development 52

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

Drug Discovery World

SEPTEMBER 14, 2023

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “Each of our non-Covid-19 therapy areas saw double-digit revenue growth, with eight medicines delivering more than $1bn of revenue in the first half, demonstrating the strength of our business. As a result of these moves, William Pao, M.D.,

Vaccine 147

Vaccine FDA Approval Drugs Licensing 147

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 52

Therapies Treatment International Licensing 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

The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. A solution could be at hand with Overland Pharmaceuticals.

Therapies 52

Therapies International Disease Research 52

Drug Discovery World

OCTOBER 18, 2022

An international business hub. Established international companies and early innovators alike are increasingly choosing to manage their operations and commercial activities from the city of Basel in north-western Switzerland. and startups to multinational corporations – covering a range of industries. .

International 130

International Engineering Science Pharmaceuticals 130

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

The Pharma Data

MARCH 17, 2022

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. Key studies in earlier stages of NSCLC include KEYNOTE-091, KEYNOTE-671, KEYNOTE-867 and KEYLYNK-012. About ETOP.

Therapies 52

Therapies Clinical Trials Disease Trials 52

Drug Discovery World

FEBRUARY 27, 2024

These immunotypes will be the basis for internal work at Noetik to discover and develop new precision cancer immunotherapies. Ron A : Our mission is to discover and develop new therapeutics to patients with diverse cancers. Reece A: Using this approach how would you like to improve upon current cancer treatments?

Engineering 130

Engineering Therapies Clinical Development Research 130

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.

Bioinformatics 104

Bioinformatics Immune Response DNA Vaccine 104

Drug Discovery World

FEBRUARY 28, 2024

Results from the trial, published in Nature Communications by researchers from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, found that MOv18 IgE was well-tolerated in the majority of patients and was able to shrink the tumour of a patient with ovarian cancer who had not responded to conventional therapy.

Drug Development 162

Drug Development Research Clinical Trials Drugs 162

Conversations in Drug Development Trends

JANUARY 24, 2024

Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. Enrolling adequate populations will be required to advance these programs.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

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

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.

RNA 63

RNA Cell Biology Clinical Development DNA 63

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

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

Drug Target Review

JUNE 3, 2024

Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments? It was published by Pfizer and Sarepta that the T cell component is responsible for toxicity in humans within gene therapy trials.

Disease 49

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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 FDA Therapies 52

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. 7 The current conditional emergency marketing authorisations are in place for situations such as the Covid-19 pandemic, where exceptions were made for the benefit of public health.

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The Pharma Data

JUNE 7, 2023

It is encouraging to see that these real-world data reinforce brexucabtagene autoleucel’s safety and efficacy, and outcomes are consistent regardless of prior course of therapy and suggest its potential benefit when used earlier in lines of treatment for relapsed/refractory patients.”

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Therapies Treatment Clinical Development International 40

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.

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