Drug Development
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
FEATURED STORIES
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
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Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy, while VBL received Fast Track designation for an ofra-vec combination in ovarian cancer.
How many boosters are enough to protect against COVID-19 infection? This question has been at the forefront of the minds of everyone as news crops up about yearly boosters.
Gamida Cell reported that the FDA had lifted its clinical hold on its cryopreserved formulation of GDA-201. It expects to launch a Phase I/II drug trial for those indications this year.
The war has shattered plans for a variety of clinical trials, but Roche is particularly concerned about fenebrutinib, a drug it is developing for multiple sclerosis (MS).
Protagonist Therapeutics’ Phase II study of an ulcerative colitis treatment failed to meet its primary endpoint at a higher dosage amount. Even so, the company remains optimistic about the drug’s future.
Nektar Therapeutics outlined a strategic reorganization plan that includes cutting 70% of its workforce. This comes only weeks after BMS abandoned its clinical collaboration program with Nektar.
Pfizer and its partner, Valneva, have announced positive Phase II data from its trial of vaccine candidate VLA15 in a pediatric population. VLA15 is intended to prevent Lyme Disease (LD).
Triebel holds the distinction of having discovered LAG-3 in 1990. Today, the company he founded is leveraging the handy molecule against cancer and autoimmune disease.
The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.
The DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.