Drug Development
Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.
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The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
Recent breakthroughs and three decades of progress in treating Huntington’s disease
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GSK will help commercialize Brexafemme (ibrexafungerp), currently approved to treat vaginal yeast infections and vulvovaginal candidiasis (VVC).
BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
The RSV race has lost one high-profile contender as Janssen announced it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.
Tuesday, Viking Therapeutics released Phase I results for its weight-loss candidate VK2735, which demonstrated a good safety and tolerability profile and resulted in significant weight reductions.
Intra-Cellular Therapies’ Caplyta met its primary endpoint in the Phase III Study 403 trial, easing the burden of depressive episodes in patients with major depressive disorder or bipolar depression.
Bicycle Therapeutics and Novartis announced Tuesday they have inked a deal worth up to $1.7 billion to discover and develop targeted radioligand therapies in oncology.
Monopar Therapeutics is dropping its lead candidate, Validive, after it failed to meet efficacy markers in Phase IIb/III trials for severe oral mucositis.
Merck’s Keytruda appeared to outperform GSK’s Jemperli in a key endometrial cancer patient subgroup, based on late-stage data revealed Monday during the Society of Gynecologic Oncology 2023 Annual Meeting.
Despite a tough financing market, ArriVent Biopharma closed a $155 million Series B to fund a pivotal Phase III trial of its non-small cell lung cancer asset.
UNITY Biotechnology’s lead asset, UBX1325, failed to show non-inferiority to Regeneron’s blockbuster Eylea in a Phase II wet age-related macular degeneration trial.