Category - Developments

Developments

Health Canada approves Spartan Bioscience rapid COVID-19 test

Health Canada approved Spartan Bioscience’s DNA analyzer, the Spartan Cube, as a rapid, accurate and portable COVID-19 test. Closely-held Spartan plans to immediately begin shipping the test to its federal and...

April 13, 2020

Developments

Bellerophon submits IND for INOpulse inhaled nitric oxide for COVID-19

Bellerophon Therapeutics (NASDAQ:BLPH) submitted an IND to the FDA to study INOpulse, a pulsed nitric oxide (NO) system, for the treatment of patients with COVID-19. The IND follows the FDA’s allowance of treatment with...

April 9, 2020

Developments

Novavax sets first-in-human trial for coronavirus vaccine candidate in mid-May

Novavax (NASDAQ:NVAX) identified a coronavirus vaccine candidate, NVX-CoV2373, using its nanoparticle technology, and will initiate a first-in-human trial in mid-May. Novavax’s Matrix-M adjuvant will be incorporated...

April 8, 2020

Developments

FDA clears Mesoblast IND for remestemcel-L in ARDS caused by COVID-19

Mesoblast (NASDAQ:MESO; ASX:MSB) received clearance from the FDA for an IND application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with intravenous infusions of its allogeneic...

April 6, 2020

Developments

IntelGenx adjusts VersaFilm business strategy

IntelGenx Technologies (TSXV:IGX; OTCQX:IGXT) unveiled a series of initiatives aimed at helping the company address, and satisfactorily respond to, the complete response letter that it recently received from the FDA...

April 6, 2020

Developments

Profound Medical launches TULSA patient website in U.S.

Profound Medical (NASDAQ:PROF; TSX:PRN) launched a newly designed TULSA Procedure website, for residents of the U.S. suffering from a prostate condition. “This new site aims to be credible and focused on providing clear...

April 3, 2020

Developments

Ennaid Therapeutics developing antiviral for COVID-19

Closely held Ennaid Therapeutics is advancing development of ENU200 as a therapeutic to treat the up to 80% of asymptomatic, mild-to-moderate cases of COVID-19 viral infections. ENU200 is a repurposed, patent-pending...

April 2, 2020

Developments

FDA accepts Mesoblast BLA for RYONCIL; agrees to priority review

The FDA accepted for priority review Mesoblast’s (NASDAQ:MESO; ASX:MSB) biologics license application filing for RYONCIL, its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft...

April 1, 2020

Developments

MEI Pharma gets FDA fast track designation for follicular lymphoma

MEI Pharma’s (NASDAQ:MEIP) ME-401 received FDA fast track designation for the treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies. The company is...

March 31, 2020

Developments

Zucara Therapeutics in $21-million Series A funding led by Perceptive Xontogeny

Closely held Zucara Therapeutics closed a $21-million Series A financing led by the Perceptive Xontogeny Venture (PXV) Fund. Proceeds will be used for Phase 1 and Phase 2 clinical trials of ZT-01, Zucara’s first-in...

March 31, 2020

Category - Developments

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