Category - Developments

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

Developments

Provention Bio begins Phase 3 trial of teplizumab for recent onset Type 1 diabetes

Provention Bio (NASDAQ:PRVB) has dosed the first patient in its Phase 3 clinical trial of teplizumab for Type 1 diabetes (T1D). The trial will determine whether teplizumab, an anti-CD3 monoclonal antibody, slows the...

April 9, 2019

Developments

Chembio’s test for Zika, dengue and chikungunya approved by Brazil health regulator

Chembio Diagnostics’ (NASDAQ:CEMI) Zika/dengue/chikungunya multiplex test has been approved by Brazil’s health regulatory agency, ANVISA. The test uses Chembio’s DPP technology platform to detect both active infection...

April 9, 2019

Developments

IntelGenx receives positive feedback for Montelukast VersaFilm at ADPD conference

IntelGenx’s (TSX-V:IGX) (OTCQX:IGXT) Montelukast VersaFilm program received positive and constructive feedback from the scientific community at the 14thInternational Conference on Alzheimer’s & Parkinson’s Diseases...

April 8, 2019

Developments

Valeritas V-Go reports greater A1C reduction with 24% less daily insulin

Valeritas Holdings’ (NASDAQ:VLRX) V-Go wearable insulin delivery device significantly lowered Type 2 diabetes (T2D) patients’ average A1C levels, compared with those using standard insulin treatment. Valeritas’ V-GoAL...

April 8, 2019

Developments

Trovagene AML drug generates positive interim Phase 1b/2 data

Trovagene (NASDAQ:TROV) announced positive interim data from its Phase 1b/2 dose escalation trial of onvansertib, in combination with standard-of-care chemotherapy, in acute myeloid leukemia (AML) patients. Three of six...

April 5, 2019

Developments

SELLAS and top cancer center to study drug combination for mesothelioma

SELLAS Life Sciences Group (NASDAQ:SLS) and Memorial Sloan Kettering Cancer Center will conduct a Phase 1 study of SELLAS’ galinpepimut-S (GPS) in combination with nivolumab in patients with relapsed or refractory...

April 5, 2019

Category - Developments

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