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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Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scientists are conducting research into the possibility of creating a vaccine that activates T cells that targets not just SARS-CoV-2 but also its variations, even the ones that cause common colds.
As the capabilities have been proven, AI is establishing a firm foothold in the key areas of R&D, drug development, clinical trials, and, to some extent, patient-facing products.
Eisai and Biogen announced positive updates on the Phase IIB 201 and open-label extension studies they are conducting on the use of lecanemab to treat early Alzheimer’s Disease.
Between January 4, 2020 and October 30, 2021, COVID-19 accounted for 576 deaths among children 17 and younger, compared to 189 from influenza, according to the CDC.
AC Immune’s Phase II Lauriet study of investigational anti-Tau monoclonal antibody, semorinemab, in mild-to-moderate Alzheimer’s disease (AD), only met one endpoint.
The company is investigating the death of a 75-year-old woman who died of ARIA while receiving Aduhelm.
A research team at the University of North Carolina – Chapel Hill (UNC) and Duke University, in Durham, NC identified an antibody that attacks SARS-CoV-2 and its variants and other types of coronaviruses.
Exavir Therapeutics announced that it was able to eliminate HIV from human cells with lipid nanoparticle (LNP)-delivered Tat-targeted CRISPR-Cas9.
FDA
Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.