Santhera

Buoyed by new data, Santhera preps filing for DMD drug vamorolone

A year ago, Swiss biotech Santhera was slashing staff to cut costs after it abandoned lead Duchenne muscular dystrophy (DMD) therapy idebenone. Now, it’s ready to file replacement drug vamorolone, armed with new data from a pivotal trial, in what looks like a reversal of its fortunes. With prospects for idebenone looking shaky, Santhera snapped …

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PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: …

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Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy

Shots: The P-IIb VISION-DMD study involves assessing the efficacy & safety of vamorolone (2&6 mg/kg/day) vs PBO and prednisone (0.75 mg/kg/day) in 121 ambulant boys aged 4 to <7 years with DMD for 48 wks. The study met its 1EP i.e improvement in TTSTAND velocity, following the 1st period @24 wks. The 2 EPs include …

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Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the …

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Santhera Halts P-III SIDEROS Study Evaluating Puldysa in Patients with DMD

Shot:     Santhera has discontinued the development of Puldysa (idebenone) in patients with DMD who are in respiratory decline and receive concomitant glucocorticoid treatment. The DSMB has recommended the discontinuation of the SIDEROS study due to futility as it fails to meet its 1EPs i.e. the change of FVC%p from baseline to 18mos. of treatment Following …

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