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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Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential approval.
As Omicron dominates the COVID-19 landscape, scientists are urging the FDA to reconsider how the agency defines immune responses.
Faron Pharmaceuticals announced a new analysis that estimates 100% overall survival at 12-months for patients who experienced clinical benefit following treatment with bexmarilimab.
Bayer has lured another top oncology expert from GlaxoSmithKline. Tara Frenkl is joining the Germany-based life sciences giant as the new head of oncology development.
Long COVID is loosely defined as COVID-19 symptoms that persist for longer than four weeks from an initial diagnosis. Here’s a look at the latest in long COVID research.
The WHO has indicated support for Pfizer’s Paxlovid and reversing a previous decision on using antiviral remdesivir, now recommending it in cases of mild to moderate COVID-19.
Servier is poised to go to market soon after the Phase III trial of its proposed drug for leukemia closed with positive results.
Orasis Pharmaceuticals announced that its eye drop candidate CSF-1 met all primary and key secondary endpoints in Phase III clinical trials. CSF-1 is intended to treat presbyopia.
Clinical results announced this week could expand COVID-19 prevention options for the immunocompromised and vaccine ineligible, as well as those that have already contracted COVID.
Moderna is poised to seek the regulatory authorization of its COVID-19 vaccine in children between six months and 5 years.