Cinclus Pharma has been granted exemption by the EMA and FDA from the requirement for pediatric studies for linaprazan glurate in the treatment of H. pyloriinfection. This simplifies development and strengthens the ability to reach the market efficiently. The drug, which potentially requires only a narrow-spectrum antibiotic, could reduce antibiotic resistance and offer a new standard of care. The exemption also extends data exclusivity to 10 years in the US and 11 years in Europe.
Cinclus Pharma skips pediatric studies for linaprazan glurate
Notes
OncoZenge receives investment proceeds from Yangtian Bio-Pharmaceutical
Xspray Pharma confirms bioequivalence for XS003
Evaxion converts debt of EUR 3,5 million
Episurf improves results and focuses on the US
Dynavox Group acquires RehaMedia for EUR 5,8 million
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