Shots:
Pharmanovia has signed an exclusive in-licensing agreement with Radius Health for abaloparatide (US brand name: Tymlos) to treat osteoporosis, expanding its osteoporosis franchise
Pharmanovia will handle clinical, regulatory & commercial responsibilities across APAC region (China, Singapore, Thailand, Indonesia, Vietnam, Taiwan, Hong Kong, Malaysia, Macau & Philippines), while Radius will get an upfront, regulatory…

Shots:
The CHMP has granted a positive opinion to Obodence (60mg pre-filled syringe) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva (denosumab), respectively
Opinion was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males (n=168), in terms of AUC from time zero to infinity &…

Shots:
The EMA has accepted the marketing authorization application of AVT03, a biosimilar version of Prolia & Xgeva (denosumab)
Submission was based on the AVT03-GL-C01 trial among postmenopausal women (n=532) with osteoporosis as well as AVT03-GL-P01 (n=209) & AVT03-GL-P03 (n=208) studies among healthy adults, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs …

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…

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…

Shots:
Laura spoke about the non-drug intervention study to treat osteopenia in postmenopausal women
She also talked about the company’s OsteoBoost technology which is a convenient treatment to improve bone density
The interview provides an understanding of the company’s vision to develop new treatment options for osteoporosis and osteopenia
Smriti: Brief us about the background behind…