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4 Unique Challenges of Oncology Trials

Advarra

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 This means study startup times can vary greatly.

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Novo Nordisk: positivity for haemophilia treatment  

Drug Discovery World

The company has been investigating Mim8 in its Phase I & II FRONTIER1 study and recently reported positive interim results from the study at the International Society of Thrombosis and Haemostasis Annual Congress (ISTH 2022) in London, UK. . Abstract presented at International Society of Thrombosis and Haemostasis (ISTH) 2022.

Treatment 130
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Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

The Pharma Data

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. The Phase 2b trial is expected to begin during the second half of 2021.

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Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

The Pharma Data

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Author: Minton. Presentation Number: P1133.

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Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Agency IQ

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

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