Published on Saturday August 05, 2023
Smooth Drug Development July 2023 News Release
We are working on the following new projects:
- We were awarded with 6 bioequivalence trials with Gliclazide, Liraglutide, Vildagliptin, Dolutegravir and Empagliflozin 10 mg and 25 mg.
- We were awarded with a Phase III study in pain with a cream based on bioactive concentrate.
- Smooth is preparing a contract for medical writing and data management services with Nebivolol.
We are happy to reach the following milestones in our projects:
- A safety report was prepared for 50 patients in India in the international phase III clinical trial of the original drug for patients with chronic myeloid leukemia. We are waiting for a regulatory decision. DSMB was performed and decision is to continue the trial.
- We prepared CTA submission documents for the Bedaquiline trial.
- All patients were randomized in the trial in adhesions during surgeries.
- 800 subjects are enrolled in the observational program of multivitamins in pregnant and childbearing women.