Drug Discovery World

APRIL 25, 2023

University of California researchers have dosed the second participant in their clinical trial to identify a potential cure for HIV utilising CAR-T cell therapy. The trial is the first-in-human clinical study investigating the duo CAR-T cell therapy for the treatment of HIV. “We

Research 130

Research Clinical Trials Therapies Clinical Development 130

Drug Discovery World

JULY 13, 2022

Novo Nordisk has announced positive interim results for its Mim8 antibody which is being as a treatment for haemophilia A. . 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.?? .

International 130

International Clinical Trials Clinical Development 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

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 It finalized a draft guidance published in 2022.

Therapies 59

Therapies FDA Production Regulations 59

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

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.

Regulations 130

Regulations Therapies Production Clinical Trials 130

Drug Discovery World

FEBRUARY 28, 2024

According to the American Association of Cancer Research (AACR) 2 , research-driven advances in treatments have resulted in the decline in death rates for melanoma, leukaemia, and kidney cancer. The drug, MOv18 IgE (an anti-folate receptor alpha IgE antibody), was developed by researchers at King’s College London. expressing cancers.

Drug Development 162

Drug Development Research Clinical Trials Drugs 162

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.

Clinical Development 40

Clinical Development Disease Clinical Trials Pharmaceutical Companies 40

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 Treatment 52

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

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.”. About 108,000 people of more than 140 nationalities work at Novartis around the world.

Treatment 52

Treatment Clinical Development FDA Therapies 52

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

Science Drugs Clinical Trials Licensing 147

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. The university aims to identify treatments for life-threatening anti-microbial diseases and metabolic disorders.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

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

Conversations in Drug Development Trends

JANUARY 24, 2024

Many parents are hesitant to pursue testing since it will not affect the patient’s care management, as several of these diseases have no approved treatments, such as Fragile X, a syndromic form of autism. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

The Pharma Data

MARCH 17, 2022

Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. About EORTC.

Therapies 52

Therapies Clinical Trials Disease Trials 52

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

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 64

Doctors Therapies Science Pharma Companies 64

The Pharma Data

OCTOBER 14, 2020

a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. SAN CARLOS, Calif. , 15, 2020 /PRNewswire/ — Apexigen, Inc. ,

Treatment 40

Treatment Immune Response Clinical Trials Clinical Development 40

The Pharma Data

JANUARY 14, 2021

PRA Health Sciences selected for the study which will position Awakn at the Forefront of Psychedelic Research for Addiction Treatment. While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high. To learn more about PRA, please visit www.prahs.com.

Science 52

Science Treatment Clinical Trials Clinical Development 52

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

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

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. Mevidalen/D1PAMs.

Disease 40

Disease International Research Therapies 40

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

FEBRUARY 27, 2024

This radically changed how we think about both cancer biology and also the treatment landscape because we could develop medicines targeting these specific genotypes and pathways, giving rise to precision therapeutics. Reece A: Using this approach how would you like to improve upon current cancer treatments? Ron A : Absolutely.

Therapies 130

Therapies Engineering Clinical Development Research 130

Drug Discovery World

JUNE 5, 2023

New approaches to partnering In this event in the Biotech track, Clive Cookson, Science Editor at the Financial Times, interviewed John McDonald, Corporate Vice President, Global R&D Business Development, Novo Nordisk. How best to communicate this strategy to both internal and external stakeholders? How to improve its pipeline?

Small Molecule 130

Small Molecule Treatment Science Disease 130

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

JUNE 7, 2023

Higher CR was seen when Tecartus was given as second-and-third-line compared to later lines of treatment. The data are being presented orally today at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO) (Abstract #7507).

Therapies 40

Therapies Treatment Clinical Development International 40

The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). LogicBio is also developing a Next Generation Capsid platform for use in gene editing and gene therapies. Commenting on the announcement, Daniel Gruskin, M.D.,

FDA 52

FDA Treatment Clinical Trials Clinical Development 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. UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

The Pharma Data

SEPTEMBER 6, 2021

The primary efficacy outcome was met showing a statistically significant reduction in the 24-hour cough count (average hourly cough frequency based on 24-hour sound recordings) of up to 27% for eliapixant 75 mg twice daily over placebo after 12 weeks of treatment. About the Phase IIb Study. About the Phase IIb Study.

Trials 52

Trials Clinical Trials International Treatment 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

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 52

Drug Discovery World

JULY 17, 2024

Imperial College spinout NK:IO was awarded a £1.6m ($2m) Innovate UK New Cancer Therapeutics grant in 2023 to develop a pioneering NK cell therapy. DS: How can NK cell therapy tackle the limitations of cancer immunotherapy? How soon can we expect a therapy to reach the clinical development phase?

Therapies 130

Therapies Engineering Small Molecule Clinical Development 130

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. LUND, Sweden , Nov. About BioInvent.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

Drug Target Review

JUNE 3, 2024

In preclinical studies to date, treatment with CNP-103 in the NOD mouse model of diabetes has shown the ability to significantly increase the regulatory T cell phenotypes of both antigen-specific Tregs and TR1 cells. This allows us to compress preclinical development and go directly into proof-of-concept Phase 2 studies.

Disease 49

Disease Pharmaceuticals Therapies Production 49

The Pharma Data

MARCH 23, 2023

The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

Trials 40

Trials Therapies Treatment Disease 40

The Pharma Data

JUNE 7, 2023

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN). 6 There are currently no TROP2 directed ADCs approved for the treatment of lung cancer. Rahway, NJ, USA), an anti-PD-1 therapy.

Trials 40

Trials Protein Expression Therapies Treatment 40