GlycoNex Reports the Completion of P-I Study Assessing SPD8 (Biosimilar, Prolia) for Osteoporosis

Shots: GlycoNex, in partnership with Mitsubishi Gas Chemical Company, has concluded the P-I trial assessing SPD8, biosimilar version of Prolia (denosumab), for treating osteoporosis. Both the companies have completed the P-I study across Japan Based on these results, SPD8 will proceed to P-III trial aimed at assessing its efficacy, safety & immunogenicity among larger…

ByDipanshu DixitAugust 19, 2024

News

Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China

Shots: The NMPA approved Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg), an anti-RANKL mAb, to treat unresectable giant cell tumors of the bone or resectable’s which may lead to severe functional impairment Maiweijian vs XGEVA (original product) has shown similarity in PK, PD, clinical efficacy and safety in patients with solid tumor bone metastases The P-I &…

ByDipanshu DixitApril 3, 2024

News

Mabwell Highlights Results from the P-III Study of MW032 (biosimilar, denosumab) for Solid Tumors in JAMA Oncology

Shots: 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…

ByDipanshu DixitFebruary 19, 2024

INSIGHTS+

Disease of the Month- Osteoporosis

To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research Continuing the series for the disease of the month, PharmaShots brings a condensed report on Osteoporosis, a bone and tissue disorder October 20th is observed as…

BySenior EditorOctober 12, 2023

GlycoNex Reports the Completion of P-I Study Assessing SPD8 (Biosimilar, Prolia) for Osteoporosis

Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China

Mabwell Highlights Results from the P-III Study of MW032 (biosimilar, denosumab) for Solid Tumors in JAMA Oncology

Disease of the Month- Osteoporosis

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GlycoNex Reports the Completion of P-I Study Assessing SPD8 (Biosimilar, Prolia) for Osteoporosis

Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China

Mabwell Highlights Results from the P-III Study of MW032 (biosimilar, denosumab) for Solid Tumors in JAMA Oncology

Disease of the Month- Osteoporosis

FOLLW US

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