Drug Discovery World

AUGUST 8, 2022

Earlier this year, pharmaceutical company Novo Nordisk announced positive results from Phase I & II clinical trials investigating its antibody treatment for haemophilia A. . We look forward to moving into phase 3 clinical development, which is due to commence in Q4 2022. Could you elaborate on this?

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Treatment Clinical Trials International Disease 130

The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). of participants in the trial, respectively.

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Clinical Trials Treatment Trials Disease 52

The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy. Haematologica 2010;95(4):567–573.

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Treatment Disease Small Molecule Production 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.

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Pharmacokinetics Clinical Trials Trials Treatment 52

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). Human and mouse genetics can inform not only efficacy but also safety.

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Production Small Molecule Regulations Trials 115

The Pharma Data

MARCH 17, 2021

This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. Gallen International Breast Cancer Conference. Gallen International Breast Cancer Conference Poster Awards 2021. The abstracts presented at St.

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Trials Therapies Treatment Pharmacokinetics 52

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

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Science FDA Production Trials 40

The Pharma Data

OCTOBER 18, 2020

“We diligently and thoughtfully prepared for this trial,” said William G. CG-806 is an oral, first-in-class FLT3 and BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of lymphoid and myeloid hematologic malignancies. Rice, Ph.D., Forward Looking Statements.

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Small Molecule Clinical Trials Trials Therapies 40

The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. The secondary outcome involves pharmacokinetic endpoints. Small Molecule Inhibitors.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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Vaccine Therapies Trials Clinical Trials 52

Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. These assessments should be performed prior to any type of manufacturing change regardless of the stage of product development (i.e., including well before and after product approval).

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Biosimilars Science FDA Licensing 40

Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. These issues are especially apparent in treatments that are intended for chronic use.

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FDA Science Clinical Trials Trials 40

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” The Phase III clinical development program consists of three studies, the BRIDGE study, the BALANCE study and the BRIGHT study. CARMIEL, Israel and BOSTON , Dec. Galactosidase-A enzyme.

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Clinical Trials Disease Treatment Trials 52

The Pharma Data

SEPTEMBER 27, 2020

Roche’s Chief Medical Officer and Head of Global Product Development. These results build on the efficacy and safety demonstrated by Evrysdi in pivotal trials, and we look forward to continued assessments of both survival and motor function during long-term follow up for this first-of-its-kind treatment.”. months and the oldest was 45.1

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Pharmacokinetics FDA Approval Treatment Clinical Trials 52