Drug Development
While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
FEATURED STORIES
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
At Sarepta Therapeutics, we’ve seen it all. Here are the questions I believe we should be asking to move forward in Duchenne muscular dystrophy.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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The pivotal study of zilganersen in Alexander disease missed a secondary endpoint, but analysts expect the FDA to approve the asset given the unmet need and overall data.
The deals keep rolling in, with Lilly penning a $7 billion pact for gene delivery biotech Kelonia Therapeutics and UCB taking over cell therapy-focused Neurona Therapeutics; President Trump signed a new executive order supporting the development of psychedelic therapies, sparking fanfare and concern alike; and the FDA’s recent Replimune decision has triggered broader debate about the agency’s flexibility.
In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
As technology becomes more integrated and personalized, experts say the biggest opportunity in diabetes management is reducing everyday burdens.
With programs from Eisai and Hansoh Pharmaceutical in hand, Tortugas Neuroscience has emerged with hopes of delivering daily oral treatments to patients with central nervous system conditions.
A triplet regimen comprising Merck’s Welireg and PD-1 blockbuster Keytruda and Eisai’s Lenvima flopped in a Phase 3 renal cell carcinoma trial.
Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer.
The Phase 3 failure has prompted Gilead Sciences and Arcus Biosciences to terminate a mid-stage study of their TIGIT asset in lung cancer.
An investigational cocktail was tied to a 0% overall response rate in patients with gastroesophageal cancer, but developers Agenus and MiNK Therapeutics aren’t giving up on the program just yet.
Novo Nordisk’s etavopivat elicited a 27% drop in vaso-occlusive crises and 48.7% hemoglobin response after 24 weeks, creating “separation amongst PK class candidates,” Truist analysts said on Monday. Novo plans to seek FDA approval in the back half of 2026.