Drug Discovery World

APRIL 10, 2024

iECURE has been given the go-ahead to begin US trials of its investigational gene editing-based therapy in newborn males with neonatal onset Ornithine Transcarbamylase (OTC) deficiency. Secondary objectives are to assess the pharmacokinetics and efficacy of ECUR-506.

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Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect.

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Drug Discovery World

AUGUST 3, 2023

Dr Sodergren told DDW in an exclusive comment: “I am hopeful that over the next few years we will see further investments by governments and funding bodies to accelerate pre-clinical and clinical research programmes.

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The Anticancer Fund

APRIL 1, 2022

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). Blockade of IL1 signalling prevents iCAF senescence upon irradiation, including through the use of the repurposing candidate anakinra, and improved therapy response.

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Drug Discovery World

APRIL 11, 2024

The Program Committee Chairs commented: “It has been an educational, enlightening, and inspiring week of captivating cancer science and research. The addition of nab-sirolimus to endocrine therapy or PI3K-AKT-mTOR pathway inhibitors may mutually overcome mechanisms of resistance induced by single-agent treatments.

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The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod.

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Drug Discovery World

AUGUST 8, 2022

Zero bleeds were reported in the eight participants treated with the therapy once monthly. . We look forward to moving into phase 3 clinical development, which is due to commence in Q4 2022. RA: Could you discuss how Mim8 works as a therapy and its benefits to patients (less frequent dosing etc.).

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Drug Discovery World

FEBRUARY 20, 2023

Chiara De Biase, Director of Support and Influencing at Prostate Cancer UK, said: “It’s fantastic that thousands of men are being given early access to darolutamide alongside traditional hormone therapy and chemotherapy, which could massively improve their survival.

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Harrison, MD, Director, Summit Clinical Research. Currently no curative or specific therapies are available.

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Alta Sciences

AUGUST 28, 2023

The trial was performed at Altasciences’ clinical facility in Montréal. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. We are proud to support Ischemix in advancing this vital new therapy.”

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The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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The Pharma Data

AUGUST 9, 2021

Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Levi Garraway, M.D., Safety outcomes were consistent with those seen in previous trials. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

DECEMBER 23, 2020

Marketing Authorization was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. Ilya Pharma – Sweden’s Ilya Pharma announced it extended its research collaboration in immunophysiology with Uppsala University.

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Agency IQ

FEBRUARY 2, 2024

Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration granted Breakthrough Therapy designation to France-based Inventiva’s experimental NASH treatment lanifibranor. Lanifibranor is believed to be the first drug candidate to be granted this status for the treatment of NASH since January 2015. Axol Bioscience – Based in the U.K.,

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