Category - Developments

Developments

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...

January 16, 2020

Developments

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...

January 15, 2020

Developments

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...

January 15, 2020

Developments

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...

January 15, 2020

Developments

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...

January 15, 2020

Developments

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...

January 14, 2020

Developments

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...

January 14, 2020

Developments

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...

January 14, 2020

Developments

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...

January 14, 2020

Developments

IntelGenx updates on cannabis-infused VersaFilm and RIZAPORT programs

IntelGenx (TSXV:IGX; OTCQX:IGXT) has finalized its cannabis-infused VersaFilm product with co-development partner, Tilray (NASDAQ:TLRY), and has completed manufacturing scale-up work. “Because we believe this is an...

January 13, 2020

Category - Developments

Tyme Technologies doses first patient in Phase 2 sarcoma trial

Kala Pharma completes enrollment in Phase 3 dry eye disease trial

Novavax gets fast track designation for NanoFlu in older adults

Mesoblast to complete rolling BLA for Ryoncil this month

IntelGenx gets Health Canada approval to proceed with amended Phase 2a Montelukast VersaFilm trial

Mereo BioPharma reports additional positive Phase 2b setrusumab data

BioLineRx gets EMA orphan drug designation for pancreatic cancer drug

FDA clears Biocardia Morph DNA deflectable guide catheter

Interface Biologics spins-out Ripple Therapeutics to focus on Epidel drug delivery technology

IntelGenx updates on cannabis-infused VersaFilm and RIZAPORT programs

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