Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
A recent Nature Review Drug Discovery article caught our attention, a review of TIGIT as an IO target and the failed Phase 3 study of tiragolumab which is the TIGIT inhibitor from Roche.[1] The science writer interviewed a group of insiders that had a lead role in the development of Continue reading The Tiragolumab Saga & Tifacogin Flash-Backs
David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”. He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS
Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to a single-digit factor. In other words, as more data accrue, Continue reading The Letermovir Top-Line Results are Out – Or Are They?