Tom Isett, Strategic Advisor and Board Member iBio (NYSE American:IBIO) is continuing its transition from a licensing business to a manufacturing services provider and developer of proprietary biologics. Central to the...
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Tyme Technologies doses first patient in Phase 2 sarcoma trial
Tyme Technologies (NASDAQ:TYME) dosed the first patient in its HopES Phase 2 trial evaluating SM-88 for the treatment of high-risk sarcomas. SM-88, or racemetyrosine, is a modified tyrosine derivative designed to...
Kala Pharma completes enrollment in Phase 3 dry eye disease trial
Kala Pharmaceuticals (NASDAQ:KALA) completed enrollment in its STRIDE 3 Phase 3 clinical trial of EYSUVIS for the short-term treatment of dry eye disease. The trial’s inclusion/exclusion criteria have been modified from...
Novavax gets fast track designation for NanoFlu in older adults
The FDA granted fast track designation for Novavax’s (NASDAQ:NVAX) NanoFlu, a seasonal influenza vaccine candidate, in adults 65 years of age and older. “We believe that NanoFlu will offer an innovative improvement...
Mesoblast to complete rolling BLA for Ryoncil this month
Mesoblast (NASDAQ:MESO; ASX:MSB) plans to file the final module of the rolling biologics license application for Ryoncil with the FDA in January and then request a priority review of the BLA under the product...
IntelGenx gets Health Canada approval to proceed with amended Phase 2a Montelukast VersaFilm trial
Health Canada has issued a no objection letter in response to IntelGenx’s (TSXV:IGX; OTCQX:IGXT) amended clinical trial application for the ongoing Montelukast VersaFilm Phase 2a (BUENA) clinical trial in patients with...
Mereo BioPharma reports additional positive Phase 2b setrusumab data
Mereo BioPharma (NASDAQ:MREO) reported additional data from its Phase 2b ASTEROID clinical study of setrusumab in adults with Type 1, 3, and 4 osteogenesis imperfecta (OI). OI, also known as brittle bone disease, is...
BioLineRx gets EMA orphan drug designation for pancreatic cancer drug
BioLineRx (NASDAQ:BLRX) received European Medicines Agency orphan drug designation (ODD) for motixafortide for the treatment of pancreatic cancer. Motixafortide is a short synthetic peptide designed to target CXCR4, a...
FDA clears Biocardia Morph DNA deflectable guide catheter
The FDA has granted 510(k) clearance for Biocardia’s (OTCQB:BCDA) Morph DNA deflectable guide catheter. The catheter is designed to enhance procedural control of therapeutic catheters, particularly Biocardia’s Helix...
Interface Biologics spins-out Ripple Therapeutics to focus on Epidel drug delivery technology
Closely-held Interface Biologics launched Ripple Therapeutics, a privately held, clinical stage developer of novel drugs. The launch comes four months after Interface sold its Endexo surface modification business to...
Just a few of the companies we’ve highlighted along the way
