Designation

Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Shots: OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at a precise, individually calibrated frequency, encouraging the body to reduce bone resorption & potentially create new bone An initial study showed that just one 30min treatment with OsteoBoost …

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ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020) Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing …

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Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Shots: The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a reduction in huntingtin mRNA in SMA patients Novartis expects to initiate the P-IIb study for branaplam in HD patients in 2021 Branaplam (qw, PO) is …

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