Drug Development
The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid painkillers, Jefferies analysts suggested.
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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Data presented at the ASCO meeting this weekend show that treatment with Enhertu demonstrated a 49% improvement in median overall survival by more than six months.
The early data demonstrated a favorable safety profile and encouraging indications of clinical activity. BNT122 is being developed in multiple solid tumor indications.
The study revealed that Yescarta was both safe and effective in adult patients regardless of race and ethnicity.
Gilead Sciences shared what seemed to be good news regarding Trodelvy in HR+/HER2- breast cancer at the 2022 American Society of Clinical Oncology’s annual meeting.
Well-known for its neurological drug development programs, Alkermes has firmly planted its flag as an oncology company at ASCO. Alkermes Head of Oncology Jessicca Rege spoke with BioSpace.
Primary seven-year data from Janssen’s (Johnson & Johnson) Phase III trial of Imbruvica (ibrutinib) in lymphoma demonstrated positive survival outcomes.
It was a busy, busy week for clinical trial news and updates, largely driven by the annual ASCO meeting taking place June 3-7 in Chicago.
Amylyx Pharmaceuticals shared news that the FDA has extended the review period for AMX0035, a combination drug treatment with the potential to treat patients with ALS.
The results showed that insulin icodec is as non-inferior to Sanofi’s insulin glargine, Lantus, potentially bringing another major competitor into the insulin space.
The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax’s COVID-19 vaccine.