FDA still not completely satisfied with Kamada’s inhaled AAT drug
Kamada is stuck again with a new obstacle in its way to bring the first inhaled treatment for alpha-1 antitrypsin (AAT) deficiency in the market as an alternative to currently present intravenous drugs. The company specializes in developing drugs from plasma proteins. FDA is still not completely satisfied with the proposed phase 3 protocol for nebulized AAT. Due to this problem the company won’t likely be able to start the trial before the end of the year as hoped.
FDA Snatches breakthrough designation from Synthetic Biologics after discovering death imbalance in trial data
US based pharmaceutical company, Synthetic Biologics has recently lost its breakthrough designation for drug candidate Ribaxamase. The decision was made after the FDA review that revealed an imbalance in patient deaths in a phase 2b trial of the drug. Now the company is stuck with its breakthrough designation lost, hitting the company real hard.
Psoriasis & other autoimmune disease treatment could be possible through stem cell derived compound
A group of Researchers from Washington University in St. Louis is working on stem cells and found that itaconate, a compound produced by inflammatory cells, relieved psoriasis-like symptoms in mice. The cells targets the IL-17 pathway, which has a key role in autoimmune disease.
Gene editing has shown promising results in combating HIV reservoirs
Researchers around the world are embracing Gene therapy for the treatment of HIV. That’s because of the ability to manipulate genes through this technique and particularly CCR5, which plays key role in HIV resistance and could help combat to a problem that has burdened the field for years. In case of HIV even when patients respond positively to antiretroviral treatments, even in that case they can harbor HIV “reservoirs,” that are dormant stores of virus that can resurge at any time.