Drug Discovery World

MARCH 8, 2024

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target.

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Antibody Trials In-Vitro Clinical Trials 52

Pharmaceutical Technology

APRIL 27, 2023

The treatment is now indicated for CF patients with a minimum of one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, or with a mutation in the CFTR gene that responds to Trikafta based on in vitro data. It was previously approved to treat CF in children aged between six and 11 years.

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FDA Approval In-Vitro Drugs Gene 246

Pharmaceutical Technology

MAY 4, 2023

The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results. This cohort showed a safety profile identical to that found in older children and adults.

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Camargo

NOVEMBER 29, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Small molecules have known structures and are primarily chemically synthesized. ADME and Dosing Regimen.

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Drug Discovery World

JUNE 30, 2023

Research tools, safety testing and regenerative medicines – these endless stem cell applications are powering precision, speed, and new modalities in drug development. Stem cells for use in drug discovery Stem cells are fast becoming an invaluable tool in the drug discovery process.

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Development Drugs In-Vitro Gene Therapy 52

Pharmaceutical Technology

OCTOBER 5, 2022

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial.

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In-Vitro In-Vivo Sales Clinical Trials 279

Pharmaceutical Technology

FEBRUARY 1, 2023

The dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance. Ellipses Pharma stated that the dual FLT3 inhibition and Aurora kinase demonstrated to overcome the acquired resistance to selectively inhibit FLT3 in vitro and in vivo.

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FDA Approval In-Vivo In-Vitro Trials 130

Drug Discovery World

FEBRUARY 22, 2024

Libra Therapeutics is a San Diego-based biotech focused on developing novel disease-modifying therapeutics, which restore the cellular balance that is disrupted in neurodegenerative diseases. This article is sponsored by Collaborative Drug Discovery. Security built in to CDD Vault is critical when working with multiple CROs.

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Clinical Trials Clinical Trials Trials In-Vivo 52

Pharmaceutical Technology

APRIL 12, 2023

FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples. Repotrectinib has been developed to combat cancer resistance to existing therapies and exert consistent anti-tumor activity. The ROS1 gene is altered in approximately in 1-2% of lung cancer patients.

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Genome Genomics In-Vitro Gene 130

Pharmaceutical Technology

MAY 31, 2023

ZNA-1041 is under clinical development by F. 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. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases.

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XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Dr. Dhiman is a scientific expert in molecular infectious disease and women’s health and is actively engaged in multiple clinical trials with a special interest in rapid molecular diagnostics for sepsis.

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Manufacturing Clinical Trials Clinical Trials In-Vitro 108

Pharmaceutical Technology

MAY 16, 2023

The approval also includes clearance for a Phase I clinical trial protocol of NXP900. Nuvectis Pharma chairman and CEO Ron Bentsur stated: “The IND clearance by the FDA is a significant milestone for the NXP900 development programme and for our overall corporate strategy, further demonstrating our ability to execute our business plan.

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Drug Discovery World

MAY 9, 2023

Jantzen Sperry , PhD, Director of Scientific Operations at Certis Oncology looks at how the adoption of orthotopic PDX models can elevate the impact of cancer research and improve translation in oncology drug development. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

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Development Drugs In-Vivo Clinical Trials 52

XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. All drug development processes evaluate a drug’s pharmacokinetics (PK) to gather data about its absorption, distribution, metabolism, and excretion in the body.

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Clinical Trials Clinical Trials Trials Antibody 98

pharmaphorum

SEPTEMBER 29, 2022

Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy. The FDA’s General Approach to Regulating mHealth Products.

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Drug Discovery World

MARCH 8, 2023

BAT8008 was developed by using Bio-Thera Solutions’ ADC linker-payload that includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8008 has a strong cell membrane penetration ability.

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Trials In-Vivo In-Vitro Antibody 52

XTalks

MARCH 1, 2021

NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials. Pfizer Inc.

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pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Clinical Trials Clinical Trials Trials In-Vitro 98

Pharmaceutical Technology

MAY 24, 2023

Our board and management team believe that the combined company will be well-positioned to develop powerful new therapies with the potential to overcome resistance to current immunotherapies, an area of significant unmet need.” Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0,

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Gene Therapy In-Vivo In-Vitro Immune Response 130

Pharmaceutical Technology

MAY 10, 2023

Under the two-year deal, both parties expect to develop new treatment methods for patients’ unmet AML and breast cancer needs at a reasonable price. The research teams will examine the use of CytoMed’s allogeneic gdTc on multiple AML and breast cancer subtypes in vitro and in vivo.

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pharmaphorum

OCTOBER 4, 2022

Such non-device CDS are: (1) not intended to acquire, process, or analyse a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system (Criterion 1); (2) intended for the purpose of displaying, analysing, or printing medical information about a patient or other medical information (e.g.

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Development Regulation Cosmetics Life Science 102

Drug Discovery World

JANUARY 31, 2024

Breye Therapeutics, a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, has started a Phase Ib/IIa clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular oedema (DMO).

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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The Pharma Data

APRIL 22, 2023

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.

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Pharmaceutical Technology

JUNE 5, 2023

Pralsetinib is under clinical development by F. 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. Hoffmann-La Roche and currently in Phase II for Pancreatic Cancer. Buy the report here.

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Bioengineer

JANUARY 16, 2024

Analysis of circulating tumor (ct) DNA at the time of treatment discontinuation or progression showed that 49% of patients in the AURA3 trial lacked the T790M mutation. Often, the loss of T790M is associated with the development of alternative competitive resistance mechanisms. months vs. 15.2 months, p = 0.01). months, 95% CI 1.3,

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Roots Analysis

MAY 21, 2024

In allogeneic cell therapies, the cells are engineered ( to elicit a desired therapeutic response ) and amplified in-vitro. According to the Alliance for Regenerative Medicine, the number of clinical trials being conducted for allogeneic cell-based cancer therapies increased by 30% over the past five years.

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Drug Discovery World

APRIL 8, 2024

Aviv Regev, Head and Executive Vice President of Research and Early Development at Genentech, opened the session with a discussion of how advances in genomic sequencing are fostering the development of data-rich cell atlases and what that data could mean for new insights into cancer biology and novel therapeutics.

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In-Vivo In-Vitro Antibody Protein 52

Drug Discovery World

MARCH 26, 2024

DDW’s Megan Thomas caught up with Oliver Rausch, Chief Scientific Officer at Storm Therapeutics, following the ESMO Targeted Anticancer Therapies Congress 2024, a global meeting focusing on promising new anticancer targets and agents, focusing on those in early phase clinical development. MT: What data did you present at the conference?

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Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 5 clinical trials, which are ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Pharma Mar Overview Pharma Mar discovers, develops and markets marine-derived drugs to treat cancer.

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Hormones In-Vitro Genotype Bacteria 100

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. In 2021 there were an estimated 1.5

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Research In-Vitro Clinical Trials Clinical Trials 52

World of DTC Marketing

JULY 12, 2021

According to a report on CNN.com “Pfizer said it is seeing waning immunity from its coronavirus vaccine and says it is picking up its efforts to develop a booster dose that will protect people from variants.” Pfizer and Moderna both have reported six-month follow up data from their phase 3 trials. ” So who to believe?

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Drug Discovery World

OCTOBER 25, 2023

iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumour survival pathways, has published new research data in the peer-reviewed journal Cancer Research, that supports a strategy of combining autotaxin inhibitor IOA-289 with TGF-β pathway inhibitor IOA-359.

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Roots Analysis

AUGUST 18, 2023

The process of drug development and safety testing is extremely expensive and time-consuming. Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions.

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