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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BioNTech announced an expansion on its collaboration with Regeneron to continue advancing mRNA technology and develop novel treatments for a variety of cancers.
The XTEND-1 study showed that efanesoctocog alfa met its primary endpoint of clinically meaningful bleed prevention in people ages 12 years and older with severe hemophilia.
From artificial intelligence breakthroughs to at-home genetic testing, here are some ways COVID-19 has changed the biopharma industry and what we may see in the near future.
The single-shot chikungunya vaccine was shown to be safe and effective against mosquito-transmitted chikungunya disease in a published analysis of Phase III results.
Potential outbreaks in Ukraine, genetic variants cause worsened symptoms, new long-term effects discovered and Florida political representatives advise against vaccines for kids.
Currently, women with breast and ovarian cancers have limited treatment options. Anixa Biosciences, ImmunoGen and IMV are working to change that.
The trial’s primary endpoint was to assess endometrial health, with additional goals of evaluating the safety and tolerability of the drug.
Agenus and Targovax partner on a KRAS cancer vaccine, Elixirgen and Taisho target aging and Tonix and Mass General team up again to fight kidney transplant rejection.
Gilead Sciences posted some good news: a late-stage study of its antibody-drug conjugate Trodelvy shows promise in slowing the progression of the most common forms of breast cancer.
The FDA clinical hold comes after Alpine reported a patient died during the NEON-2 trial.