News

The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
FEATURED STORIES
Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
THE LATEST
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.
FDA
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.
FDA
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.
Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.
Marstacimab decreased bleeding rates by 92% in patients with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.