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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Incyte Corporation reported that the FDA has pushed back the review of the company’s supplemental New Drug Application (sNDA) for Opzelura (ruxolitinib cream) for vitiligo.
In the latest results shared by the company, treatment with nusinersen for a median of 4.9 years helped participants maintain and make progressive gains in motor function.
Shares of Sanofi took a hit in premarket trading after it announced its Phase II breast cancer study assessing an experimental oral SERD failed to hit the mark.
Pfizer will cease operations within Russia and proceeds from its subsidiary in that country will be donated to provide direct humanitarian support to the people of Ukraine.
A new study out of Duke University added weight to the determination that asthma in children did not increase infection risk, children slow to get COVID vaccine and more COVID-19 news.
The U.S. FDA has approved Lynparza for the adjuvant treatment of patients diagnosed with germline BRCA-mutated HER2-negative high-risk early breast cancer.
Novartis released new data Monday from its Phase III SPR1NT trial that reinforces the benefits of Zolgensma.
This week is starting off strong with some positive clinical news from Ascendis Pharma, Can-Fite and BridgeBio.
AstraZeneca’s Fasenra hit a roadblock after the FDA issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
Bristol Myers Squibb and Nektar Therapeutics said their joint Phase III PIVOT IO-001 study did not meet two endpoints: progression-free survival and objective response rate.