Phase III
Novartis is not resting on the laurels of having the first-ever-approval for a CAR-T cancer drug, Kymriah.
Investors in beleaguered Argos are smiling this morning after the company announced some positive interim data for its Phase III kidney cancer drug, Rocapuldencel-T - a trial that some said should have been scrapped months ago.
The RESULT study allows for more frequent and higher dose adjustments based upon clinical signs and symptoms than the previous Phase 3 SOLUTION study.
The company plans to meet with FDA to discuss results and clinical requirements for registration.
The positive results support the company’s planned regulatory submissions.
Bristol-Myers is initiating a Phase III clinical trial of BMS-986205 with nivolumab in patients with advanced melanoma.
Alnylam and Sanofi Genzyme presented positive Phase III results of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy at a conference in France.
For most biopharma sponsors, the crux of their challenge is how to identify an adequate number of evaluable patients to sufficiently power their late phase clinical research.
Astra and its MedImmune division announced that two Phase III clinical trials of tralokinumab for severe, uncontrolled asthma failed to meet their primary endpoints.
The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend Indivior’s RBP-6000 to treat opioid use disorder.
PRESS RELEASES