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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The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
Speculations that Biogen might appeal the decision after reports of the company hiring several lobbyists, including Clyburn Consulting and Federal Street Strategies.
Tarsus announced positive topline data from its Phase III clinical trial of TP-03 Demodex blepharitis, along with the commencement of an underwritten public offering of $50 million of shares of its common stock.
Public health officials are seeing a notable rise in cases and expressing concerns over more subvariants of the SARS-CoV-2 virus. For those stories and more, continue reading.
Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.
Since its $63 billion acquisition of Allergan in 2019, AbbVie has become one of the leading companies developing therapies for migraine.
Shares of Praxis Precision Medicines are falling after the company announced the FDA has placed a clinical hold on the company’s IND Application for its experimental epilepsy drug, Prax-222.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.
A roundup of last week’s top clinical trial updates and news.