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 and currently in Phase I for Solid Tumor. Roche is headquartered in Basel, Switzerland.

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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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XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Such precise detection is crucial for accurately pinpointing patients most susceptible to developing severe HDFN.

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XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota. This is where collaboration meets innovation, and an effective strategic partnership can truly spark achievement.

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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

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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pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. 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. The FDA’s General Approach to Regulating mHealth Products.

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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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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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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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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. The new mRNA sequence would be based on the B.1.351

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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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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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The Pharma Data

MAY 3, 2021

In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year. . Posted 03 May 2021 | By Michael Mezher .

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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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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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XTalks

APRIL 18, 2024

This test, which is being co-developed with Eli Lilly, has the potential to facilitate earlier and more accurate detection of the disease. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

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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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Drug Discovery World

FEBRUARY 6, 2024

She speaks to Megan Thomas on how genomics can advance drug discovery and development. She speaks to Megan Thomas on how genomics can advance drug discovery and development. In vitro and in silico models are becoming increasingly sophisticated in predicting drug safety profiles and preventing costly and time-consuming clinical trials.

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Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. This has a measurable impact: Those born vaginally are at a lower risk of developing asthma, juvenile arthritis, and immune deficiencies, among other conditions 3.

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The Pharma Data

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days quicker compared to placebo. days; 95% C.I, days; 95% C.I,

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Drug Discovery World

AUGUST 22, 2023

Originator pharma companies are developing ever more complex products, which are transforming the medical landscape, but their cost places an increasing burden on healthcare budgets worldwide. It could also include specialty products that are harder to develop compared to standard generic products. What are complex generics?

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XTalks

FEBRUARY 1, 2023

The researchers found that factors in the blood can potentially predict the risk of developing the disease years before a clinical diagnosis is made. Some Alzheimer’s patients start off by developing mild cognitive impairment (MCI), which is a condition that involves worsening memory or cognitive ability.

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pharmaphorum

FEBRUARY 13, 2022

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process.

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Drug Discovery World

DECEMBER 8, 2023

Investments in AI and related technologies are driving this seismic shift where modest improvements in early-stage drug development success rates enabled by AI and machine learning could lead to an additional 50 novel therapies over 10 year s, a more than $50 billion opportunity.

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pharmaphorum

FEBRUARY 19, 2021

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. The cash will also help develop two other preclinical drugs, EBT-104 for Herpes Simplex Virus and EBT-107 for hepatitis B.

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Drug Discovery World

APRIL 5, 2023

A collaborative network The CBC operates as a collaborative network of 19 Institutes with longstanding drug discovery know-how from target identification through to proof-of-concept clinical trials. The post Only non-US company joins cancer drug discovery consortium appeared first on Drug Discovery World (DDW).

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Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). When an investigational device does not carry this potential for serious risk, the clinical investigation is NSR.

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XTalks

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery disease and the physicians that treat them.” million of that in the third quarter of its 2023 fiscal year.

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FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. §

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Drug Discovery World

JULY 3, 2023

Key updates The findings presented by Dr Christian Klein, Head of Oncology Programs and Department Head of Cancer Immunotherapy Discovery, Roche Innovation Center Zurich, Roche Pharma Research & Early Development, pRED, bear major implications for the development of the next-generation of IL-2 therapies.

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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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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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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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XTalks

APRIL 6, 2022

The personalized ctDNA blood test uses the RaDaR™ assay, a liquid biopsy platform developed by the company Inivata. The personalized blood test uses an assay called RaDaR™ , a next-generation sequencing (NGS) liquid biopsy platform developed by the biotech company Inivata. Photo source: Inivata.

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Drug Discovery World

JUNE 12, 2023

Those are the beginning of additional manufacturing, scale of chemistry pharmacokinetics, pharmacology assays, development bioanalytical assays, and then moving forward toxicology work to start the initial clinical trials. Thomas speaks with Dennis Brown, Chief Scientific Officer at Kintara Therapeutics.

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XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

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