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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Burlingame, CA-based Innoviva is buying all of Waltham, MA-based Entasis Therapeutics’ available shares at $2.20 per share. Currently, Innoviva owns about 60% of Entasis’ outstanding shares.
Biohaven Pharma’s NDA for its nasal spray zavegepant was accepted by the FDA, while Phase III results for its drug troriluzole to treat spinocerebellar ataxia were disappointing.
Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
A small research study published in Jama shows people with a lower body mass index (BMI) tended to maintain immunity against COVID-19 longer.
Regeneron Pharmaceuticals shared positive results from its Phase III trial of an evinacumab for children with homozygous familial hypercholesterolemia.
Vir Biotechnology terminated a two-year-old COVID-19-related antibody collaboration with Wuxi Biologics that included sotrovimab, which lost EUA in the U.S. earlier this year.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Elicio Therapeutics published data on the preprint server bioRxiv, describing preclinical research into its cancer vaccine that shows a lot of promise.
Alnylam Pharmaceuticals shared 18-month results from its phase III Helios-A clinical study demonstrating that vutrisiran improves clinical cardiac symptoms in patients with hATTR.
Two experimental drugs from Seres Therapeutics and Vera Therapeutics celebrate clinical trial wins in hard-to-treat disease areas.