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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Gilead has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
The San Diego-based immunology company is locating and developing molecules where the mechanism of action has either been proven or makes sense.
After decades of treating the big categories of heart disease – hypertension, for example – the ability to address the genetics of heart disease is within sight.
January has been a largely quiet month for PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. There were two dates for the entire month, and one of those has been moved back to April. Here’s a look.
Pazdur, along with the FDA’s R. Angelo de Claro and Gautam Mehta from the Center for Drug Evaluation and Research, penned an opinion piece published Thursday in JAMA Oncology.
Sorrento Therapeutics announced its COVID-19 treatment, Covishield, shows major progress in neutralizing Omicron and Omicron (+R346K) variants of SARS-COV-2.
Visionary tech magnate Elon Musk is taking his neurotech company to the next step toward in-human trials of his implantable brain-machine interface.
Public health officials churn out a lot of statistics related to COVID-19, but it can often be difficult to determine just how accurate they are because there are just so many unreported test results.
The Glycogen Storage Disease Program at Connecticut Children’s and UConn Health reported success in a Phase I/II trial of a gene therapy for GSD-Ia.
The data is coming in right away for Alnylam in one of its primary indications, transthyretin-mediated (ATTR) amyloidosis.