Ivacaftor Safe in CF Infants Aged 1 to 4 Months
A phase 3 clinical trial, ivacaftor (Kalydeco, Vertex Pharma) was generally safe to administer to infants aged 1-month to <4-months old, according to research published in Journal of Cystic Fibrosis.
A phase 3 clinical trial, ivacaftor (Kalydeco, Vertex Pharma) was generally safe to administer to infants aged 1-month to <4-months old, according to research published in Journal of Cystic Fibrosis.
The Cystic Fibrosis Foundation is investing up to $9 million in additional funds in Arcturus Therapeutics to test ARCT-032, an inhaled messenger RNA therapeutic candidate that could treat the underlying cause of cystic fibrosis in all people living with the disease.
The phase 2 clinical trial is expected to be a multi-center, randomized, double-blind, placebo-controlled study assessing the drug’s safety and effectiveness in treating approximately 90 pulmonary sarcoidosis patients.
The phase 1 trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.
Read MoreA phase 1 clinical trial will test an experimental mRNA universal influenza vaccine known as H1ssF-3928 mRNA-LNP.
Read MoreThe oral, direct-acting antiviral drug candidate is being evaluated in the global phase 3 SUNRISE-3 registrational trial for the treatment of COVID-19 in outpatients at high risk for disease progression regardless of vaccination status.
Read MoreIn a phase 1 clinical trial, the vaccine developed by NIAID’s Vaccine Research Center was safe, well-tolerated, and induced broad antibody responses that target the hemagglutinin stem.
Read MoreThe National Cancer Institute has helped launch the phase 3 Pragmatica-Lung Study to assess a two-drug combination to treat patients with advanced non-small cell lung cancer (NSCLC).
Read MoreJanssen had been enrolling participants in a phase 3 trial to demonstrate the efficacy of its RSV vaccine candidate in adults age 60 and older.
Read MoreIn preclinical mouse studies, CLB073 significantly enhanced the efficacy of Nix-TB drug regimen, the current standard of care for drug-resistant tuberculosis.
Read MoreThe trial evaluated the safety and immunogenicity of AAHI’s vaccine candidate compared to the previous iteration of the vaccine—a two-vial presentation that had demonstrated promising safety and immunogenicity in Phase 2 clinical testing.
Read MoreThe expansion of the clinical trial follows the clearance of an Investigational New Drug application by the US Food and Drug Administration, announced earlier this year.
Read MoreThe US Food and Drug Administration has accepted Merck’s new supplemental Biologics License Application based on data from the trial.
Read MoreA multisite clinical trial will evaluate an investigational COVID-19 antiviral known as the Shionogi antiviral (S-217622) or ensitrelvir fumaric acid.
Read MoreBiomX has announced positive data from a study assessing the safety and tolerability of BX004 in nine cystic patients.
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