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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Pennsylvania-based Ocugen has submitted an Investigational New Drug (IND) to the FDA to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.
The clinical study on ANG-3777 demonstrated a modest but not clinically significant difference in the placebo group’s estimated glomerular filtration rate.
On Tuesday morning, Provention Bio announced positive interim results from its Phase I PROVENT study of PRV-101.
In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.
BioNTech plans to increase its manufacturing capacity in Africa over time through the supplementation of new manufacturing lines and construction of additional manufacturing sites.
Mammoth Biosciences just announced a collaboration with Vertex to develop in vivo gene-editing therapeutics for patients with either of two serious, but not-yet-disclosed diseases.
Axcella announced it is initiating a new clinical program to study AXA1125 in patients with Long Covid. The trial will be conducted at the Oxford Centre for Clinical Magnetic Resonance Research.
Nuravax is developing an Alzheimer’s vaccine to induce therapeutically potent concentrations of antibodies against pathological proteins. Know more here.
If the panel votes in favor of the vaccine for children, it will move to the U.S. CDC. If both agencies support the data, children this age would be likely to receive their first shots in early November.
Initial results showed a strong neutralizing antibody response and favorable safety profile among the participants.