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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A largely untested and unproven treatment for Alzheimer’s disease, called transcranial pulse stimulation (TPS), is becoming popular around the world, although experts are skeptical.
Eligo Bioscience has thought of a way to solve the dysbiosis between our bodies and our microbiomes – gene editing. BioSpace spoke with Eligo Co-founder and CEOXavier Duportet, Ph.D.
Several new biotech and biopharma companies are sharing their strengths to develop new treatments for high-need diseases diabetes, Alzheimer’s and cancer.
The FDA has issued special designations that could improve the lives of millions with recurrent glioblastoma or hemophilia diagnoses.
Axsome Therapeutics published results of its Phase III trial of AXS-05 that demonstrated rapid, substantial and statistically significant improvement in depressive symptoms.
Bristol Myers Squibb (BMS) has announced late-breaking data showing deucravacitinib significant efficacy at the primary endpoint for the treatment of systemic lupus erythematosus (SLE).
Sage Therapeutics and partner Biogen shared news that their phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD).
The U.S. FDA has requested some additional data from BioMarin Pharmaceuticals for the BLA it filed for the hemophilia A therapy valoctocogene roxaparvovec.
Eledon Pharmaceuticals announced positive topline results from its Phase IIa clinical trial evaluating tegoprubart in patients with amyotrophic lateral sclerosis (ALS).
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.