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The rising impact of biomarkers in early clinical development

Drug Target Review

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Biomarkers can play a crucial role throughout clinical development, especially in early phases. 21(10):3517.

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Novo Nordisk: Phase 3 Data Shows Mim8 Well-Tolerated After Switch from Emicizumab in Hemophilia A

The Pharma Data

The study marks a significant step forward in the treatment landscape for haemophilia A, demonstrating not only clinical safety and pharmacokinetic stability, but also strong patient preference for the Mim8 pen-injector delivery system. The clinical development of Mim8 comes at a time of significant innovation in haemophilia care.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

One of the most significant challenges in drug development is global regulatory variability. While international agencies strive for harmonization through organizations such as the International Council for Harmonisation (ICH), regulatory frameworks differ significantly across regions.

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The future of mental health treatment: Zelquistinel’s role

Drug Target Review

The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. He is the inventor of more than 130 granted US patents and has overseen the discovery, IND filing and clinical development of over 12 clinical candidates in pain, cognition, depression and a range of ophthalmic and dermatologic diseases.

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Merck Announces Presentation of New Data from Broad HIV Program at IAS 2021

The Pharma Data

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. Abstract 1914.

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Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

LifeSciVC

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).

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RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 8] , [9] , [10] , [11] , [12]. **In