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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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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.
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FDA
The company added an indication to Lynparza’s label for the treatment of adults with metastatic castration-resistant prostate cancer, while cutting an antibody for Crohn’s disease and ulcerative colitis.
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.
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.