Drug Development
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
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Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
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Servier Pharmaceuticals’ Vorasidenib, acquired from Agios in a $1.8 billion deal, slowed the growth of a certain type of low-grade glioma by 61% in a Phase III trial.
Combined with chemotherapy, Keytruda in KEYSTONE-671 significantly improved EFS and reduced the risk of disease recurrence, progression or death by 42%, beating Imfinzi’s EFS in the AEGEAN trial.
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 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.
The company’s blockbuster JAK inhibitor, alone or as a combination therapy, showed durable improvements in systemic lupus erythematosus disease activity at 48 weeks.