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 requested additional data analyses from the pediatric studies that Merck stated it has submitted. The final decision is expected on July 1, 2022.
Although the data suggests the vaccines are extremely effective and generally safe, analysis is still coming in about adverse events as well as effectiveness in specific patient populations.
Cerevance reported positive clinical trial results for CVN424, an experimental treatment for Parkinson’s disease.
Origami’s precision technology platform, Oricision™, is focused on diseases that affect the central nervous system rather than oncology.
Vertex Pharmaceuticals has announced meaningful results from two Phase II studies of its therapeutic VX-548. It is a non opioid pain medication that promises results.
Taysha Gene Therapies announced that it will focus its efforts on clinical programs targeting Rett Syndrome and giant axonal neuropathy (GAN), resulting in a 35% reduction in its workforce.
CAR-T cell therapy is still a time-consuming and expensive process. But researchers may have just solved the turnaround-time challenge for CAR-T.
The U.S. FDA placed a partial hold on CytoDyn’s HIV program and a full clinical hold on its COVID-19 program in the U.S.
It’s a promising day for advanced ovarian cancer research as two biopharma companies achieved positive results. Here’s what you need to know about research.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.