Drug Development

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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.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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The Danish vaccine maker’s respiratory syncytial virus candidate did not meet all primary endpoints in a late-stage study in older adults and the company is discontinuing the program.
Despite the lifting of the FDA’s partial clinical hold, Gilead will discontinue magrolimab’s development in higher-risk myelodysplastic syndromes after a Phase III study met the bar for futility.
The infectious diseases market is expected to reach $150 billion in sales by 2029, with three pharma giants reaping most of its benefits, according to data analytics and consultancy GlobalData.
The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.
CSL’s AEGIS-II trial and cell and gene therapy expansion highlight the significant global expansion within the company over the past five years.
Following seven patient deaths in a Phase II study, ADC Therapeutics is discontinuing the development of its Zynlonta antibody-drug conjugate—combined with Rituxan—for diffuse large B-cell lymphoma.
Even at its highest dose, Vir Biotechnology’s investigational flu shot failed to significantly outperform placebo at preventing influenza A illness in a mid-stage study.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
With Eisai and Biogen’s Leqembi now fully approved, researchers are exploring combinations—including with therapies targeting tau and microglial function—that could increase its effectiveness.
BioSpace rounded up companies with products for Alzheimer’s, ALS, Parkinson’s and Huntington’s in the final stages of clinical testing.