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Follow news from the American Society of Clinical Oncology 2023 annual meeting—BioSpace will be tracking key updates here throughout the conference.
The Swiss pharma’s CDK4/6 inhibitor reduced risk for recurrence by 25% when added to the standard-of-care endocrine therapy, inviting comparisons to Lilly’s Verzenio.
The company’s Humira biosimilar Yusimry will launch in July with a $995 list price. Mark Cuban’s online pharmacy will sell it at a list price of $569.27 plus fees.
The company’s aztreonam-avibactam matched the cure rate of a meropenem-based regimen in patients with drug-resistant infections.
The recent approval of Biogen’s Qalsody in SOD1–ALS highlighted the potential of ASOs in CNS diseases, while recent failures make it clear there is still work to be done.
ADCs from BioNTech, Daiichi Sankyo and Merck are the subject of high-profile abstracts featured at the oncology meeting, along with Merck’s late-breaking Phase III non-small cell lung cancer data.
Drugs that act on the CFTR protein only work in patients who produce the protein in the first place. That leaves 6% of patients hanging.
The FDA has three high-profile events this week, including one target action date and two advisory committee meetings—one to discuss potential traditional approval for Alzheimer’s drug Leqembi.
Roger Perlmutter’s company announced the addition Thursday of myriad early- to mid-stage assets in the cancer and neurodegenerative disease spaces.
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.
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.