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Navigating Regulatory Hurdles in Drug Development

DrugBank

Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring. Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review.

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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. Donello was most recently Vice President of External Science & Innovation at Allergan/AbbVie, where he led R&D innovation efforts to develop strategic collaborations, in-license clinical-stage assets and evaluate M&A opportunities.

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AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

The Pharma Data

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S.

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Everest Medicines Announces Amended Agreement with Spero Therapeutics

The Pharma Data

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. SHANGHAI , Jan.

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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). asset has not been de-prioritized due to safety or efficacy)?

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Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

The Pharma Data

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As Cofounder and Chief Scientific Officer of Selva Therapeutics. About Selva Therapeutics.

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NorthSea Therapeutics doses first patient in Phase 1 trial of SEFA-1024 in dyslipidemia and further expands its clinical pipeline

The Pharma Data

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. ‘SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

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