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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What the appearance of yet another variant shows is the “unpredictability of the emergence of SARS-CoV-2 variants,” according to the researchers who discovered IHU.
GeneTx Biotherapeutics and Ultragenyx Pharmaceutical’s jointly prepared treatment for Angelman syndrome have been provided a green single by DSMB recently.
The NASH trial achieved the primary endpoint of proton density fat fraction and the secondary endpoint of cT1.
An improvement in cUHDRS was observed in more than half of all evaluable patients and was specifically seen in 75% of the evaluable population who showed excess complement activity at baseline.
A bispecific antibody discovered by Twist Bioscience and licensed to Revelar Biotherapeutics neutralizes both the Omicron and Delta variants of SARS-CoV-2 in studies with the live virus.
FDA
Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
More than 103,000 people in the U.S. were hospitalized on January 3, 2022, for COVID-19—the highest daily figure of hospitalizations since last summer when the Delta variant emerged.
AVROBIO is switching priorities in 2022 away from its Fabry disease program and into its other more lucrative clinical-stage projects.
While women are more statistically susceptible to autoimmune diseases, the research found that men with at least a mild COVID-19 infection had far more autoantibody (AAB) reactivity.
The FDA decided to lift the hold for its Phase IIa trial of SPR720 after Spero submitted a comprehensive analysis from the NHP toxicology study.