Shots: The P-I study involves assessing pharmacokinetics, safety, and tolerability of DMB-3115 with its reference products (US- and EU-marketed products) in 296 healthy volunteers at a single site in the EU DMB-3115 showed bioequivalence to the reference and was well tolerated. The reported AEs corresponded with the known safety profile of ustekinumab with no new […]Read More
Shots: The P-I study will evaluate the PK and safety profile of R-107 vs PBO in patients with PAH. Earlier, Claritas licensed R-107 from Salzman Group and collaborated with it, under which get an exclusive WW right to develop R-107 for the treatment of PAH CMAX will initiate a P-Ia study for R-107 (IM) and […]Read More
Shots: The P-I trial involves assessing MSB-0221 (ShA9) or vehicle applied topically on forearm skin in 54 adults with staphylococcus aureus-positive AD for 1week The expression of mRNA for psmα was inhibited from S. aureus isolated from all participants while the correlation was observed within 7days b/w improvement in local eczema severity and killing of […]Read More
Shots: The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high […]Read More
Shots: The study involves assessing of JHL1266 vs Prolia sourced from the EU and the US in healthy human subjects evaluating its PK, PD, and immunogenicity The JHL1266 is proved to be a milestone and an initiative in bringing safe, effective, and high-quality biologics JHL1266 is a mAb targeting RANKL works by inhibition of developed […]Read More
Shots: :Stosohth:ththShots: The company reported the dosing of a first healthy volunteer in a P-I study of TD-0903 and anticipates that TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to ARDS Earlier, Theravance has received approval to initiate the P-I study for assessing safety, tolerability and pharmacokinetics of […]Read More
![Daiichi Reports Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in P-I study for HER2 Low Expressing Metastatic Breast Cancer](https://pharmashots.com/wp-content/uploads/2018/12/Daiichi.jpg)
Shots: The P-I study involved assessing of [Fam-] trastuzumab deruxtecan (5.4, 6.4 mg/kg) in 46 patients with heavily pretreated HER2 low expressing metastatic breast cancer P-I study results: ORR (44.2 %, 47.4%); disease control rate (79.1%, 81.6%); mDOR (9.4mos., 11.0 mos.); mPFS (7.6 mos., 7.9 mos.) [Fam-] Trastuzumab deruxtecan (DS-8201) is a HER2 targeting antibody […]Read More
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