Abby Hardy, Author at BioTuesdays

Developments

Ovid Therapeutics’ OV101 fails Phase 3 Angelman syndrome trial

Ovid Therapeutics (NASDAQ: OVID) reported that its Phase 3 NEPTUNE trial evaluating OV101 for the treatment of Angelman syndrome failed to meet its primary endpoint. Angelman syndrome is a rare genetic disorder that...

December 1, 2020

Developments

Profound Medical gets FDA humanitarian device exemption approval for Sonalleve

Profound Medical’s (NASDAQ:PROF; TSX:PRN) Sonalleve received FDA humanitarian device exemption (HDE) approval for the treatment of osteoid osteoma. Osteoid osteoma is a non-cancerous bone tumor that occurs most often in...

November 30, 2020

Executive Moves

Profound Medical appoints accomplished financial executive, Murielle Lortie, to board

Murielle Lortie Profound Medical (NASDAQ:PROF; TSX:PRN) appointed financial executive, Murielle Lortie, as a director, effective immediately. Ms. Lortie is the CFO of Liminal Biosciences, a Nasdaq-listed, clinical-stage...

November 30, 2020

Developments

Urovant Sciences vibegron fails Phase 2a IBS trial

Urovant Sciences (NASDAQ:UROV) reported disappointing topline results from its Phase 2b trial of vibegron for the treatment of abdominal pain due to irritable bowel syndrome (IBS) in women. The study failed to meet its...

November 25, 2020

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

Author - Abby Hardy

Ovid Therapeutics’ OV101 fails Phase 3 Angelman syndrome trial

Profound Medical gets FDA humanitarian device exemption approval for Sonalleve

Profound Medical appoints accomplished financial executive, Murielle Lortie, to board

Urovant Sciences vibegron fails Phase 2a IBS trial

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

Subscribe