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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In its financial results for 2021, Takeda announced that it has decided to discontinue the development of TAK-609, a therapeutic for Hunter Syndrome.
The FDA has given approval for the commercialization of Eli Lilly and Company and Incyte’s Olumiant, setting a precedent for upcoming COVID-19 treatments.
Jacqueline Shea will take over as the new CEO and announced plans to discontinue its Phase III Innovate trial to prioritize its heterologous booster strategy for COVID-19.
AstraZeneca and Sanofi’s Phase-III and Phase-IIb clinical trials investigating the efficacy of nirsevimab shows 79.5% efficacy in the prevention of lower respiratory tract infections.
Genentech (Roche) reported Wednesday that its Phase III SKYSCRAPER-01 trial failed to meet its co-primary endpoint of progression-free survival (PFS).
ICER recommended two out of three outpatient treatments for COVID-19 in today’s market, singling out molnupiravir as having inadequate evidence that it is better than symptomatic care.
Cortexyme has entered into a deal to acquire Novosteo. Once the deal is finalized, the companies will enter the rare disease space and operate under the name Quince Therapeutics.
Current COVID-19 booster shots have a problem: they last only about four months and appear to have limited efficacy in a vaccinated population. Clearly, a more durable approach is needed.
Despite posting its first profitable quarter as a commercial stage company, shares of Novavax plunged 20% in Tuesday trading due to the slower-than-expected rollout of its COVID-19 vaccine.
Idorsia is no longer continuing research into the use of ACT-539313 to treat binge eating disorders after failing to meet the primary endpoint in its latest trial.