The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF).

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

New Drug Approvals

MAY 22, 2025

4] The co-packaged combination sulbactam/durlobactam was approved for medical use in the United States in May 2023. [5] Fischer J, Ganellin CR (2006). “Pharmacokinetics and Pharmacodynamics of -Lactamase Inhibitors” Pharmacotherapy. 46 (31): 89808987. doi : 10.1021/bi7006146. . 46 (31): 89808987. PMC 2596720.

Pharmacokinetics 62

Pharmacokinetics FDA Production FDA Approval 62

New Drug Approvals

APRIL 27, 2025

9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed. Fischer J, Ganellin CR (2006). “Clinical pharmacokinetics of trospium chloride” Clin Pharmacokinet. 3] Its parasympatholytic action relaxes the smooth muscle in the bladder. [4] 4 (6): 43640. PMID 14622495.

FDA Approval 57

FDA Approval FDA Pharmacokinetics Licensing 57

Codon

FEBRUARY 23, 2025

Pharmaceutical developers often avoid fluorine because the element can alter pharmacokinetics, making it hard to predict how a drug will be absorbed, metabolized, and excreted. However, the element also improves lenacapavir’s stability and slows down enzymatic oxidation, allowing the molecules to survive longer in the body.

Clinical Trials 82

Clinical Trials Virus Vaccine DNA 82