Sumitomo Pharma America, Inc.

Global Clinical Trials for Myelodysplastic Syndrome Show Significant Industry Investment in 2025

3 months ago

• A comprehensive review of global Myelodysplastic Syndrome clinical trials reveals extensive research activity across G7 and E7 countries, with major pharmaceutical companies leading development efforts. • The analysis highlights significant participation from industry leaders including Bristol-Myers Squibb, Novartis, and Sanofi, demonstrating strong commercial interest in MDS therapeutics. • The report indicates evolving clinical trial landscapes across multiple regions, with detailed tracking of trial phases, enrollment trends, and success rates over the past five years.

FDA Approves Gemtesa (Vibegron) for Overactive Bladder in Men with BPH

5 months ago

• The FDA has approved Gemtesa (vibegron) for men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). • Gemtesa is the first and only beta-3 adrenergic receptor agonist approved for OAB in men being treated for BPH, addressing a significant unmet need. • Approval was based on a Phase 3 trial demonstrating significant reductions in micturition and urgency episodes compared to placebo. • Common adverse reactions in the trial included hypertension and urinary tract infections, with a similar rate of serious adverse events to placebo.

Lupin Gains FDA Approvals for HIV, Cystic Fibrosis, and Heart Failure Generics

6 months ago

• Lupin receives FDA approval for generic Sacubitril/Valsartan tablets, a heart failure therapy, targeting a $6.06 billion market. • Tentative FDA approval granted to Lupin for generic Abacavir/Dolutegravir/Lamivudine tablets, an HIV treatment for pediatric patients. • Lupin's Ivacaftor oral granules, a generic for cystic fibrosis, also receive tentative FDA approval with potential for 180-day exclusivity.

FDA Accepts Sumitomo Pharma's sNDA for Vibegron in Men with OAB and BPH

a year ago

• The FDA has accepted Sumitomo Pharma's sNDA for vibegron (GEMTESA) to treat OAB symptoms in men receiving BPH pharmacological therapy. • The sNDA is based on Phase 3 trial results showing statistically significant reductions in daily micturition and urgency episodes with vibegron. • If approved, vibegron will be the first beta-3 agonist for OAB in men undergoing BPH treatment, addressing a significant unmet need. • The FDA's target action date for the decision on vibegron's approval is set for Q3 of FY2024 under the PDUFA.