Drug Development
With inspections always on the table, LOTTE Biologics is pushing a proactive, quality first culture across its dual hubs in Syracuse and Songdo, backing its new single‑use ADC facility with rigorous training, self‑audits and real‑time regulatory surveillance.
FEATURED STORIES
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Monday, Actinium Pharmaceuticals released promising results Monday from a Phase III trial studying its lead radiotherapy candidate, Iomab-B, for patients with relapsed or refractory AML.
ESSA confirmed that Janssen has stepped away from a prostate cancer collaboration due to “operational recruitment challenges.”
An investigator in the Phase III trial for Biogen and Eisai’s experimental Alzhiemer’s drug, lecanemab, is attributing a patient’s death to the treatment.
Sanofi will drop its IL-2 candidate, citing a lack of efficacy in the early stages of data collection, the company announced in its Q3 report Friday.
Scorpion Therapeutics is on a mission to create a world where many more cancer patients can benefit from precision therapies. Earlier this year, it struck a $75 million alliance with AstraZeneca.
GSK is pulling the plug on an experimental monoclonal antibody therapy for rheumatoid arthritis following a significant miss in one of three Phase III trials.
The FDA has upheld the accelerated approval of Jazz Pharmaceuticals’ Zepzelca (lurbinectedin), even though the drug failed to reach its primary endpoint in the confirmatory Phase III ATLANTIS trial.
Alnylam Pharmaceuticals released its report for Q3, in which the company stated it will no longer initiate a Phase III trial for vutrisiran in Stargardt disease.
Two Phase III trials of Genentech (Roche)'s Vabysmo hit the primary endpoint in macular edema caused by branch and central retinal vein occlusion, showing non-inferiority to Regeneron’s Eylea.
Minneapolis-based DiaMedica Therapeutics plans to conduct additional studies in order to resolve a clinical hold on its DM199 program for the treatment of acute ischemic stroke (AIS).