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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BioSpace spoke with Janssen’s Fiona Elwood about the company’s myasthenia gravis candidate nipocalimab, which is currently recruiting for two Phase III trials.
Olema president and CEO Sean Bohen spoke with BioSpace about why he believes his company’s approach with a SERD and ER antagonist can successfully treat an advanced form of breast cancer.
VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.
BMS, TG Therapeutics, Spero and Merck are all preparing for PDUFA dates over the next couple of weeks. Here’s a closer look.
Friday morning, the FDA granted Emergency Use Authorization to both Moderna’s and Pfizer-BioNTech’s COVID-19 vaccines for use in children ages 6 months to 4 years old.
The World Trade Organization approved vaccine patent waivers to increase the availability of COVID-19 vaccines to lower-income countries.
Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant due to patient recruiting, staffing and pandemic-related issues.
Genmab and AbbVie announce positive data in large b-cell lymphoma, Intra-Cellular’s bipolar depression candidate hits the endpoint in Phase III and more.
Atreca announced that Stephen Gould, Ph.D., will be the company’s next chief scientific officer. Most recently, Gould was executive director, of Translational Oncology at Genentech.
Bavarian Nordic announced that the upcoming Phase III trial for its COVID-19 booster candidate has been redesigned to compete against licensed mRNA-based vaccines.