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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Aldeyra Therapeutics will announce three clinical trials involving ADX-629, its first-in-class oral RASP modulator, at its 2022 Research & Development Day.
Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
A new study shows that a second COVID booster is highly effective in preventing death in older adults.
Four companies, Pipeline Therapeutics, Prothena, Neuroplast, and Taysha Gene Therapies, announced launches of clinical trials in the CNS space.
Pfizer stated that etrasimod patients achieved statistically significant improvements in primary endpoints of clinical remission and attained all secondary endpoints vs. placebo.
When ImmunoGen announced top-line results from the Phase III SORAYA trial in November 2021, the primary endpoint - confirmed objective response rate - was met at 32.4%.
Typically occurring after sufferers regain their total smell loss from anosmia, parosmia is an olfactory disorder that causes smell distortions.
The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
AstraZeneca will showcase its early oncology portfolio at the American Association for Cancer Research set to begin on April 8.