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Health Canada has approved the Jubbonti subcutaneous injection to treat osteoporosis and increase bone mass. The approval is based on the results of Phase I and Phase III clinical studies results that show Jubbonti has the same safety and risk as the reference medicine (Prolia)
This human mAb and ligand inhibitor (bone metabolism regulator)…
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The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma
Patients in the trial have previously received 1-3 prior lines of therapy,…
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The results from the P-III trial comparing MW032’s (SC, Q4W, until wk. 49) safety, efficacy & PK vs reference drug (denosumab) to treat patients (n=708), randomized 1:1, with solid tumors having bone metastasis are published in JAMA Oncology
The 1EP includes percentage change in natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr) from baseline to…
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The approval was based on the study evaluating the efficacy of Aurlumyn for treating patients (n=47) with severe frostbite, all received aspirin & SoC. Patients were divided into 3 treatment arms receiving Aurlumyn (IV, 6hrs., daily for up to 8 days) alone in arm 1 & unapproved medications with/without Aurlumyn in arms 2 &…
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The approval was based on the results from 2 trials (Study 1) & (Study 2) evaluating the safety & efficacy of Eohilia (2mg, BID) vs PBO in patients (aged 11-56yrs. & 11-42yrs.) with EoE. The efficacy endpoints of the trials were histologic remission & change from baseline in patient reported DSQ post 12wks of…
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Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications
Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia…
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The P-I clinical trial evaluates the safety & efficacy of RT-111 in delivering CT-P43 (biosimilar, ustekinumab) in patients with moderate to severe plaque psoriasis, active psoriatic arthritis & IBD
As per the results, RT-111 delivered CT-P43 in a dose proportional manner with high bioavailability & depicted a higher Cmax & shorter Tmax vs ustekinumab…
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Sandoz has introduced Tyruko (natalizumab), biosimilar of Tysabri for the treatment of r/r multiple sclerosis (RRMS), in Germany which will be available from Feb 1
Polpharma Biologics is responsible for the development, manufacturing and supply of Tyruko while Sandoz holds its commercialization rights in all markets as per a global commercialization agreement signed…
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The (AVT03-GL-P01) study assessing safety, PK and tolerability of AVT03 (denosumab) vs Prolia in healthy adult individuals met the 1EPs
The confirmatory study of AVT03 in patients and a trial to evaluate PK of AVT03 vs Xgeva in healthy adult individuals is ongoing
AVT03, a mAb, targets RANK ligand to reduce the numbers…
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The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety
The results depicted that the study met its…

