Imugene and City of Hope announced this week that the first patient has begun treatment in a revolutionary Phase I clinical trial, investigating the safety and efficacy of CF33-hNIS (Vaxinia), a cancer-killing virus, in adults with metastatic or advanced tumors.
Nearly one third of patients with ulcerative colitis who received an experimental Pfizer Inc. medicine in a clinical trial were in remission after a year of treatment, the drugmaker said on Tuesday.
Regeneron Pharmaceuticals shared positive results from the company’s Phase III trial of a candidate drug for children with homozygous familial hypercholesterolemia (HoFH), a rare, life-threatening condition characterized by elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD.
Biohaven Pharmaceutical said on May 23 the company’s experimental drug for patients with spinocerebellar ataxia, a genetic disease that affects the nervous system, failed to meet the main goal of a late-stage study.
Drugmakers Pfizer Inc and BioNTech SE said on May 23 that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.
Ocugen Inc. said on May 23 the U.S. drug regulator has lifted the clinical hold on a mid-to-late stage trial of the COVID-19 vaccine being developed by the company’s Indian partner Bharat Biotech.
AbbVie submitted a New Drug Application to the U.S. Food and Drug Administration for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.
The U.S. Food and Drug Administration issued a partial clinical hold for Foghorn Therapeutics’ Phase I clinical study, investigating the safety and efficacy of FHD-286 in patients with relapsed and/or refractory acute myelodysplastic leukemia (AML) and myelodysplastic syndromes (MDS). The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.
With increasing concerns about COVID-19 reinfection, Pfizer and the National Institutes of Health are discussing potential studies regarding a longer treatment period with the antiviral medication Paxlovid.
Reportedly, Pfizer is holding the company’s COVID-19 antiviral therapy Paxlovid under tight control. This is a disappointment to numerous investigators who want to test the antiviral combination therapy with other drugs in case the virus develops resistance to the combo.
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