article thumbnail

The Composition and Value of a Portfolio Analysis

Camargo

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Biowaiver Eligibility. Nonclinical Requirements.

article thumbnail

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck. About Molnupiravir. About Ridgeback Biotherapeutics.

Trials 69
article thumbnail

Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

Pharmaceutical Technology

As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. . Important considerations for drug substance development. Polymorphic form issues.