Abby Hardy, Author at BioTuesdays

Developments

KA Imaging launches subscription model for portable X-ray device

Closely-held KA Imaging introduced a new hardware subscription model to help U.S. and Canadian hospitals acquire Reveal 35C, the company’s portable X-ray device, during the pandemic. Reveal 35C is a portable, single...

November 24, 2020

Developments

FDA clears Neuronetics TouchStar protocol for major depressive disorder

The FDA cleared Neuronetics’ (NASDQ:STIM) TouchStar protocol for the treatment of major depressive disorder. TouchStar is a three-minute intermittent theta burst protocol administered using the company’s NeuroStar...

November 24, 2020

Developments

Capricor initiates dosing in Phase 2 COVID-19 trial

Capricor Therapeutics (NASDAQ:CAPR) dosed the first two patients in its Phase 2 trial evaluating CAP-1002 for the treatment of severe COVID-19. CAP-1002 is an intravenously delivered allogeneic cardiac cell therapy...

November 24, 2020

Developments

Oramed initiates Phase 3 oral insulin trials

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) began screening patients for its two Phase 3 trials evaluating ORMD-0801 for the treatment of Type 2 diabetes. The trials will enroll a total of 1,125 Type 2 diabetes patients...

November 24, 2020

Developments

PolyPid D-PLEX100 gets FDA breakthrough therapy designation

The FDA granted PolyPid’s (NASDAQ:PYPD) D-PLEX100 breakthrough therapy designation for the prevention of surgical site infections in patients undergoing colorectal surgery. D-PLEX100 is designed to provide prolonged...

November 24, 2020

Feature

Izotropic Breast CT Imaging System targeting earlier cancer detection

Izotropic (CSE:IZO; OTC:IZOZF; FSE:1R3) is developing a dedicated breast imaging system aimed at the better detection – and potentially earlier diagnosis and treatment – of breast cancer.

November 24, 2020

Developments

FDA clears Orchard Therapeutics IND for OTL-200

The FDA cleared Orchard Therapeutics’ (NASDAQ:ORTX) IND for OTL-200, a stem cell-based gene therapy for the treatment of metachromatic leukodystrophy (MLD). MLD is caused by a mutation in the arylsulfatase-A gene, which...

November 23, 2020

Developments

FDA approves Eiger’s Zokinvy for progeria

The FDA approved Eiger BioPharmaceuticals’ (NASDAQ:EIGR) Zokinvy for the treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies. Progeria is an extremely rare and fatal disease caused by a...

November 23, 2020

Developments

Seelos Therapeutics SLS-005 gets FDA orphan drug designation for ALS

Seelos Therapeutics’ (NASDAQ:SEEL) SLS-005 (trehalose) received FDA orphan drug designation for the treatment of amyotrophic lateral sclerosis (ALS). Trehalose is a low molecular weight disaccharide that crosses the...

November 19, 2020

Developments

Kintara Therapeutics reports interim data from two Phase 2 trials of VAL-083

Kintara Therapeutics (NASDAQ:KTRA) reported interim data from two Phase 2 trials evaluating VAL-083 for the treatment of glioblastoma multiforme (GBM). In the first Phase 2 study, newly diagnosed patients receiving VAL...

November 19, 2020

Author - Abby Hardy

KA Imaging launches subscription model for portable X-ray device

FDA clears Neuronetics TouchStar protocol for major depressive disorder

Capricor initiates dosing in Phase 2 COVID-19 trial

Oramed initiates Phase 3 oral insulin trials

PolyPid D-PLEX100 gets FDA breakthrough therapy designation

Izotropic Breast CT Imaging System targeting earlier cancer detection

FDA clears Orchard Therapeutics IND for OTL-200

FDA approves Eiger’s Zokinvy for progeria

Seelos Therapeutics SLS-005 gets FDA orphan drug designation for ALS

Kintara Therapeutics reports interim data from two Phase 2 trials of VAL-083

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