Abby Hardy, Author at BioTuesdays

Developments

Helius’ PoNS treatment gets FDA breakthrough designation for MS

Helius Medical Technologies’ (NASDAQ:HSDT; TSX:HSM) portable neuromodulation stimulator (PoNS) received FDA breakthrough designation for the treatment of gait deficit due to symptoms of multiple sclerosis (MS). The non...

May 12, 2020

Developments

Imagin Medical supports Bladder Cancer Awareness Month

This month, Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) will be undertaking a number of efforts and activities to help raise awareness about bladder cancer. Imagin has created and will...

May 12, 2020

Developments

Kane Biotech posts positive results from anti-biofilm shampoo consumer product test

Kane Biotech (TSX-V:KNE) reported positive results from its consumer product test evaluating the efficacy of its new shampoo on dermatitis and dandruff. The shampoo was developed based on research indicating that...

May 12, 2020

Developments

Kiniksa Pharma updates data from COVID-19, chronic pruritis studies

Kiniksa Pharmaceuticals (NASDAQ:KNSA) reported updated data from its open-label study of mavrilimab for the treatment of COVID-19-related pneumonia, as well as its Phase 2 trial for vixarelimab for the treatment of...

May 11, 2020

Developments

Strongbridge Biopharma completes enrollment in Phase 3 Cushing’s syndrome trial

Strongbridge Biopharma (NASDAQ:SBBP) completed enrollment in its Phase 3 trial of RECORLEV for the treatment of endogenous Cushing’s syndrome, an endocrine disease caused by chronic elevated cortisol exposure. A...

May 11, 2020

Developments

FDA clears Pluristem IND for PLX-PAD in COVID-19-related ARDS

Pluristem Therapeutics (NASDAQ:PSTI) received FDA clearance for an IND application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with intramuscular injections of PLX-PAD. ...

May 8, 2020

Developments

Cytokinetics gets FDA fast track designation for chronic heart failure drug candidate

Cytokinetics (NASDAQ:CYTK) omecamtiv mecarbil received FDA fast track designation for the treatment of chronic heart failure with reduced ejection fraction (HFrEF). Omecamtiv mecarbil is a novel selective cardiac myosin...

May 8, 2020

Developments

Ovid Therapeutics reports positive topline results from Phase 2 Fragile X syndrome study

Ovid Therapeutics (NASDAQ:OVID) reported positive topline results from its Phase 2 trial of OV101 in males with Fragile X syndrome. A total of 23 participants were randomized to receive either 5 mg of OV101 either...

May 7, 2020

Developments

Puma Biotech anti-HER2 breast cancer drug approved in China

Puma Biotech (NASDAQ:PBYI) received approval to market neratinib in China via its licensing partner, CANbridge Pharmaceuticals. Neratinib, marketed as NERLYNX, is an extended adjuvant treatment for early stage HER2...

May 7, 2020

Developments

SetPoint Medical gets FDA investigational device exemption for bioelectronic platform

Closely-held SetPoint Medical received the FDA’s investigational device exemption approval to study the company’s bioelectronic platform in a pivotal trial in patients with rheumatoid arthritis (RA). The company’s...

May 6, 2020

Author - Abby Hardy

Helius’ PoNS treatment gets FDA breakthrough designation for MS

Imagin Medical supports Bladder Cancer Awareness Month

Kane Biotech posts positive results from anti-biofilm shampoo consumer product test

Kiniksa Pharma updates data from COVID-19, chronic pruritis studies

Strongbridge Biopharma completes enrollment in Phase 3 Cushing’s syndrome trial

FDA clears Pluristem IND for PLX-PAD in COVID-19-related ARDS

Cytokinetics gets FDA fast track designation for chronic heart failure drug candidate

Ovid Therapeutics reports positive topline results from Phase 2 Fragile X syndrome study

Puma Biotech anti-HER2 breast cancer drug approved in China

SetPoint Medical gets FDA investigational device exemption for bioelectronic platform

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