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Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Bioversity plans address two key pain points in the industry: the current system cannot produce enough talent to keep up with demand, and the workforce as a whole lacks diversity.
The regulator says drug compounders are selling products that falsely claim to contain the same active ingredient, semaglutide, as the blockbuster diabetes and obesity drugs.
Despite oft-reported news of layoffs, the life sciences industry continues to have golden spots of expansions in terms of jobs, year-on-year revenue and in building new facilities and programs.
Abrysvo’s approval in adults aged 60 years and above comes ahead of an expected August decision in the pediatric setting.
The company’s blockbuster JAK inhibitor, alone or as a combination therapy, showed durable improvements in systemic lupus erythematosus disease activity at 48 weeks.
Following a partial hold on another lead candidate last year, Sanofi is reinvigorating its MS pipeline with a Phase II win for its investigational anti-CD40L antibody frexalimab.
The regulator will provide PepGen with a letter within 30 days explaining why a clinical hold was placed on the company’s Phase 1 study of patients with myotonic dystrophy Type 1.
The company’s oral gut-targeting polymer, GLY-200, demonstrated promising safety and efficacy in patients with Type 2 diabetes, assessing the candidate as an adjunct treatment to diet and exercise.
Efforts are underway to fast-track approval for costly gene therapies and make them affordable to a wider patient group via reimbursement through Medicare and Medicaid.
Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.