Category - Developments

Developments

Palisade Bio gets FDA fast track for return of bowel function after GI surgery

The FDA granted fast tract designation to Palisade Bio’s (NASDAQ:PALI) LB1148 for the acceleration of time to return of bowel function following surgery. By inhibiting the activity of digestive proteases, the company...

November 22, 2022

Developments

IntelGenx receives FDA PDUFA date for RIZAFILM

The FDA accepted for review IntelGenx’s (TSX:IGX; OTCQB:IGXT) Class 2 response to a 2020 complete response letter for the company’s 505(b)(2) NDA for RIZAFILM VersaFilm for the treatment of acute migraine. The FDA has...

November 22, 2022

Developments

Kiora doses first patient in Phase 1b retinitis pigmentosa trial

Kiora Pharmaceuticals (NASDAQ:KPRX) dosed the first patient in a first-in-human open-label clinical trial for KIO-301, intended to restore vision loss in patients with retinitis pigmentosa, a rare, inherited genetic eye...

November 17, 2022

Developments

Azura posts positive Phase 2b results in meibomian gland dysfunction

Azura Ophthalmics reported positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in meibomian gland dysfunction (MGD), a leading cause of dry eye disease and contact lens discomfort...

November 17, 2022

Developments

NeuroSense receives IND clearance for Phase 2b ALS study

The FDA cleared NeuroSense Therapeutics’ (NASDAQ:NRSN) IND for its Phase 2b PARADIGM study with its lead drug candidate, PrimeC, in the treatment of amyotrophic lateral sclerosis (ALS). PARADIGM is currently enrolling...

November 15, 2022

Developments

Raymond James sees high likelihood of CPT-1 reimbursement for Profound’s TULSA-PRO

Analyst Rahul Sarugaser, Ph.D., writes that there is a high likelihood that Profound Medical (NASDAQ:PROF) will receive a category-1 CPT code from the Centers for Medicare and Medical Services when it files an...

November 15, 2022

Developments

TauRx’s announcement of positive Phase 3 LUCIDITY results triggers $119-million (U.S.) in warrant exercises

Closely-held TauRx Therapeutics of the UK received $119-million through an exercise of warrants triggered by the announcement of the Phase 3 LUCIDITY results in October, supporting hydromethylthionine mesylate (HMTM)...

November 15, 2022

Developments

Lanier Biotherapeutics receives U.S. patent for IL-25 binding molecules

Lanier Biotherapeutics announced that the United States Patent and Trademark Office has issued U.S. Patent 11,492,397, entitled, “Neutralizing Monoclonal Antibodies to IL-25 and Uses Thereof.” The patent covers...

November 14, 2022

Developments

Lantheus, POINT Biopharma to commercialize PNT2002 & PNT2003

Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma Global (NASDAQ:PNT) announced a set of strategic collaboration agreements in which Lantheus would license exclusive worldwide rights to POINT’s PNT2002 and PNT2003...

November 14, 2022

Developments

Oramed to commercialize oral insulin in Korea with Medicox

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) signed an exclusive commercial distribution agreement for the Republic of Korea with Medicox, an emerging biotech company with proven partnerships in the Korea. The agreement...

November 14, 2022

Category - Developments

Palisade Bio gets FDA fast track for return of bowel function after GI surgery

IntelGenx receives FDA PDUFA date for RIZAFILM

Kiora doses first patient in Phase 1b retinitis pigmentosa trial

Azura posts positive Phase 2b results in meibomian gland dysfunction

NeuroSense receives IND clearance for Phase 2b ALS study

Raymond James sees high likelihood of CPT-1 reimbursement for Profound’s TULSA-PRO

TauRx’s announcement of positive Phase 3 LUCIDITY results triggers $119-million (U.S.) in warrant exercises

Lanier Biotherapeutics receives U.S. patent for IL-25 binding molecules

Lantheus, POINT Biopharma to commercialize PNT2002 & PNT2003

Oramed to commercialize oral insulin in Korea with Medicox

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