Category - Developments

Developments

TRACON Pharma terminates Phase 3 TAPPAS trial in angiosarcoma

TRACON Pharmaceuticals (NASDAQ:TCON) terminated for futility its Phase 3 TAPPAS trial, evaluating TRC105 in combination with Votrient in patients with advanced or metastatic angiosarcoma, based on a recommendation of...

April 12, 2019

Developments

Hancock Jaffe implants four VenoValves in first-in-human study

Hancock Jaffe (NASDAQ:HJLI) has implanted VenoValves in four patients with severe, chronic venous insufficiency (CVI) as part of its first-in-human study of the device. CVI occurs when the valves in the veins of the leg...

April 11, 2019

Developments

Sernova announces first islet cell transplant in Phase 1/2 Cell Pouch trial

Sernova (OTCQB:SEOVF) has performed its first Cell Pouch islet cell transplant in a Phase 1/2 study of Type 1 diabetes patients. Sernova’s Cell Pouch is a micro-encapsulation device that houses, supports, and protects...

April 11, 2019

Developments

Otonomy starts Phase 1/2 trial of OTO-313 for tinnitus

Otonomy (NASDAQ:OTIC) initiated a Phase 1/2 trial of OTO-313, a novel formulation of gacyclidine, for the treatment of tinnitus. Patients with tinnitus experience noise or ringing in their ears. Otonomy notes that some...

April 11, 2019

Developments

ContraVir Pharma to present CRV431 Phase 1 data at Intl Liver Congress

ContraVir Pharmaceuticals (NASDAQ:CTRV) will present a poster on a Phase 1 single ascending dose study of its drug candidate, CRV431, at the International Liver Congress, taking place in Vienna, Austria from April 10-to...

April 11, 2019

Developments

Q BioMed discovers novel biomarkers for pediatric nonverbal autism

Q BioMed (OTCQB:QBIO) has discovered two novel biomarkers for pediatric nonverbal autism (PNA) in a subset of children with autism spectrum disorder (ASD). Children with PNA never develop the ability to speak, or begin...

April 10, 2019

Developments

Concert starts third Phase 1 study of adjunctive schizophrenia therapeutic candidate

Concert Pharmaceuticals (NASDAQ:CNCE) initiated a multiple ascending dose (MAD) study to evaluate its adjunctive schizophrenia therapeutic candidate, CTP-692, in healthy volunteers. CTP-692 is a deuterium-modified...

April 10, 2019

Developments

Avinger’s image-guided atherectomy system gets FDA pre-marketing clearance

Avinger’s (NASDAQ:AVGR) Pantheris SV (small vessel) image-guided atherectomy system, indicated for the diagnosis and treatment peripheral artery disease (PAD), has received 510(k) clearance from the FDA. Atherectomy is...

April 10, 2019

Developments

uniQure gets FDA fast track designation for Huntington’s disease gene therapy

uniQure (NASDAQ:QURE) received FDA fast track designation for AMT-130, a gene therapy candidate for the treatment of Huntington’s disease (HD). HD is an inherited neurodegenerative disorder where production and...

April 9, 2019

Developments

PhaseBio Pharma granted FDA breakthrough designation for antiplatelet reversal drug

PhaseBio Pharmaceuticals (NASDAQ:PHAS) received the FDA’s breakthrough therapy designation for PB2452, a drug designed to reverse the effects of antiplatelet drug, ticagrelor. Ticagrelor is administered to patients to...

April 9, 2019

Category - Developments

TRACON Pharma terminates Phase 3 TAPPAS trial in angiosarcoma

Hancock Jaffe implants four VenoValves in first-in-human study

Sernova announces first islet cell transplant in Phase 1/2 Cell Pouch trial

Otonomy starts Phase 1/2 trial of OTO-313 for tinnitus

ContraVir Pharma to present CRV431 Phase 1 data at Intl Liver Congress

Q BioMed discovers novel biomarkers for pediatric nonverbal autism

Concert starts third Phase 1 study of adjunctive schizophrenia therapeutic candidate

Avinger’s image-guided atherectomy system gets FDA pre-marketing clearance

uniQure gets FDA fast track designation for Huntington’s disease gene therapy

PhaseBio Pharma granted FDA breakthrough designation for antiplatelet reversal drug

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