Global pharmaceutical and healthcare corporation formed through the 2020 merger of Mylan and Pfizer's Upjohn division; produces medicines, generic drugs, biosimilars, and active pharmaceutical ingredients across multiple therapeutic areas.
Clinical Trials
6
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2020
Completed
1
16.7%
Not yet recruiting
2
33.3%
Recruiting
3
50.0%
No approval data available
- VR-205 achieved a 33.75% reduction in geometric mean urine protein-to-creatinine ratio at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001], meeting the primary endpoint. - The targeted-release budesonide formulation was well tolerated in Japanese patients, with a safety profile consistent with global Phase 3 studies. - No study participants progressed to dialysis, kidney transplant, or severe renal impairment by the end of the 9-month treatment period. - Viatris plans to submit a New Drug Application in Japan by the end of 2026, where IgAN incidence is the highest globally at 39–45 cases per million per year.
- Viatris Inc. has initiated a nationwide recall of Xanax XR 3mg extended-release tablets after the medication failed dissolution specifications during quality control testing. - The recall affects lot #8177156 with expiration date 02/28/2027, distributed to patients between August 27, 2024, and May 29, 2025. - The FDA classified this as a Class II recall, indicating potential temporary or medically reversible adverse health consequences. - Patients prescribed the affected 60-tablet bottles should stop taking the medication immediately and dispose of it safely.
- Heron Therapeutics has reached a settlement agreement with Mylan Pharmaceuticals to resolve ongoing patent litigations related to CINVANTI and APONVIE injectable emulsions. - Under the settlement terms, Heron grants Mylan a license to market generic versions of both aprepitant products in the United States beginning June 1, 2032, approximately three years before patent expiration. - The agreement concludes litigation initiated by Heron in response to Mylan's abbreviated new drug applications seeking FDA approval for generic versions prior to the 2035 patent expiration.
- An FDA advisory committee voted against approving Lexicon's Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). - The committee cited that the benefits of Zynquista do not outweigh the risks for the proposed patient population. - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 20 for the final decision on Zynquista. - Sotagliflozin, branded as Inpefa, was approved in May 2023 for heart failure patients, and Viatris Inc. recently obtained exclusive rights to commercialize it outside the U.S. and Europe.
