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San Diego-based Otonomy Inc.'s launch of the phase I/II trial for OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss brought renewed investor attention to the company, consigned to the back burner after a late-stage failure.
LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder.
Two phase II stumbles for startup Cyclerion Therapeutics Inc., an Ironwood Pharmaceuticals Inc. spinout, crushed the stock (NADAQ:CYCN), which closed down a steep 79.5% on Wednesday.
Navidea Biopharmaceuticals Inc. disclosed positive results from the first interim analysis of its ongoing NAV3-31 phase IIb study. Analysis shows the data support Navidea's hypothesis that Tc 99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA).
BEIJING – Shanghai-based Visen Pharmaceuticals is pushing its long-acting growth hormone therapy, which is also the first of its kind in China, one step closer to the NDA-stage after receiving clearance from Chinese regulators this week to start a phase III trial.
An already validated approach with Navidea Biopharmaceuticals Inc.'s radioimaging agent for rheumatoid arthritis (RA) might have presaged the victory, but that didn't stop Wall Street from rewarding the shares handsomely, and the stock (NYSE:NAVB) closed Tuesday at $1.10, up 32 cents or almost 41.5%, having traded as high as $1.36.
A JAMA Open Network study found that RNA testing determined whether 88% of variants of uncertain significance found in DNA testing for hereditary cancer genes were pathogenic or benign.
BEIJING – Shanghai-based Visen Pharmaceuticals is pushing its long-acting growth hormone therapy, which is also the first of its kind in China, one step closer to the NDA-stage after receiving clearance from Chinese regulators this week to start a phase III trial.
HONG KONG – South Korean biopharma Virocure Inc., based in Seoul, recently founded a local corporation in Brisbane, Australia. The new company, Virocure Australia Pty Ltd., will facilitate a phase I trial of cancer drug RC-402 in Australia.
BOSTON – Researchers from Memorial Sloan-Kettering Cancer Center presented encouraging, though very early, data on Merus NV's bispecific antibody MCLA-128 for the treatment of patients with NRG-1 gene fusions at the AACR-NCI-EORTC Molecular Targets meeting on Sunday.
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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