Clinical research
The company will continue to analyze data regarding the secondary endpoints.
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
The decision to carry on came after dosing for the Phase III GENERATION HD1 trial was halted following an overall risk/benefit assessment.
The problem Kinaset is trying to solve is that over time, patients receiving asthma therapies – typically inhaled corticosteroids plus bronchodilators – become steroid-refractory.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.
The Danish pharma giant is partnering with EraCal Therapeutics, to develop new obesity-related drug targets.
The approval of Cibinqo was based on data from five clinical trials of more than 1,600 people. Safety and efficacy were studied in three Phase III trials.
Unlike antibody-drug conjugates (ADCs) that focus on antigens, PDCs are able to target the tumor microenvironment that has universal features across solid tumors.
To alleviate the problem of antibiotic-resistant bacteria, or superbugs, several biotechnology companies are developing different strategies to target and kill these microorganisms.
Emergent BioSolutions, Vir Biotechnology and Thermo Fisher, come into 2022 with reports of new opportunities, new vaccines, and partnership expansions.
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