Abby Hardy, Author at BioTuesdays

Developments

Imagin Medical gets additional positive physician feedback on i/Blue Imaging System

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) has continued to collect additional input on its i/Blue Imaging System from physicians in the United States and Canada. Leading urologists...

March 10, 2020

Developments

Kala Pharma reports positive results from Phase 3 dry eye disease trial

Kala Pharmaceuticals’ (NASDAQ:KALA) EYSUVIS met both primary efficacy endpoints in a Phase 3 trial for the short-term treatment of dry eye disease. The trial, called STRIDE 3, demonstrated a statistically significant...

March 9, 2020

Developments

Neuronetics gets FDA breakthrough device designation for NeuroStar

Neuronetics (NASDQ:STIM) received FDA breakthrough device designation for its NeuroStar Advanced Therapy System for the treatment of bipolar depression. Neurostar is a transcranial magnetic stimulation device that...

March 6, 2020

Executive Moves

Covetrus names Benjamin Wolin as CEO

Benjamin Wolin Benjamin Wolin, who has been acting CEO of Covetrus (NASDAQ:CVET) since October 2019, has been promoted to president and CEO, effective immediately. Covetrus was formed in February 2019 as the result of a...

March 4, 2020

Developments

Omeros reports updated data from pivotal narsoplimab trial

Omeros (NASDAQ:OMER) reported updated data from its pivotal clinical trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. All 28 patients have completed...

March 3, 2020

Developments

Stealth gets FDA rare pediatric disease designation for elamipretide

Stealth BioTherapeutics’ (NASDAQ:MITO) elamipretide received FDA rare pediatric disease designation for the treatment of Barth syndrome. Barth syndrome is a very rare genetic condition characterized by cardiac...

March 3, 2020

Developments

Kura Oncology gets second fast track designation for tipifarnib

The FDA granted fast track designation to Kura Oncology’s (NASDAQ:KURA) tipifarnib for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma and nodal...

March 3, 2020

Developments

Karyopharm’s Phase 3 multiple myeloma trial meets primary endpoint

Karyopharm Therapeutics (NASDAQ:KPTI) reported positive topline results from its Phase 3 BOSTON study in patients with multiple myeloma who have received one-to-three prior lines of therapy. The study evaluated once...

March 2, 2020

Developments

Ra Medical begins patient enrollment in pivotal atherectomy study

Ra Medical Systems (NASDAQ:RMED) enrolled the first patient in its pivotal study of the DABRA excimer laser system for the treatment of peripheral vascular stenoses. DABRA is an atherectomy device that uses...

February 27, 2020

Developments

SELLAS reports positive follow-up data from Phase 1/2 acute myeloid leukemia trial

SELLAS Life Sciences (NASDAQ:SLS) reported final follow-up data from its Phase 1/2 study of galinpepimut-S in patients with acute myeloid leukemia (AML) in second complete remission. The data demonstrate a median...

February 26, 2020

Author - Abby Hardy

Imagin Medical gets additional positive physician feedback on i/Blue Imaging System

Kala Pharma reports positive results from Phase 3 dry eye disease trial

Neuronetics gets FDA breakthrough device designation for NeuroStar

Covetrus names Benjamin Wolin as CEO

Omeros reports updated data from pivotal narsoplimab trial

Stealth gets FDA rare pediatric disease designation for elamipretide

Kura Oncology gets second fast track designation for tipifarnib

Karyopharm’s Phase 3 multiple myeloma trial meets primary endpoint

Ra Medical begins patient enrollment in pivotal atherectomy study

SELLAS reports positive follow-up data from Phase 1/2 acute myeloid leukemia trial

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