Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
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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 FDA has rejected Cambridge, Mass.-based Akebia Therapeutics’ New D2rug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
A meeting with an amyotrophic lateral sclerosis (ALS) patient in Israel who could only speak with the assistance of a computer changed the life and direction of NeuroSense CEO Alon Ben-Noon.
Biogen will await word after submitting the final study protocol for its confirmatory Phase IV ENVISION trial of Aduhelm to the U.S. Food and Drug Administration (FDA).
A team at the University of California, San Diego developed a drug screening method to help determine why Alzheimer’s drugs fail. The system analyzes disease mechanisms in human neurons.
Researchers have developed a new form of UV light that is safe for people but decreased the level of indoor airborne microbes by more than 98% in less than five minutes.
Despite being represented in clinical research, no solutions have been found to circumvent the effects of Alopecia areata. However, there may be hope.
Although it looks that we’re on the downside of the COVID-19 pandemic in the U.S., biopharma companies are still working on developing better treatments and preventions.
Interim data from Genentech’s first randomized study on a candidate treatment for extensive-stage small-cell lung cancer failed to meet its co-primary endpoint.
Data from Clene’s RESCUE-ALS trial showed that treatment with CNM-Au8 significantly slowed progression of ALS and improved quality of life.
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.