Abby Hardy, Author at BioTuesdays

Developments

PAVmed subsidiary gets breakthrough device designation for esophageal DNA test

PAVmed’s (NASDAQ:PAVM) subsidiary, Lucid Diagnostics, received FDA breakthrough device designation for its EsoGuard esophageal DNA test. The EsoGuard test, which is performed on esophageal samples collected using...

February 11, 2020

Developments

PhaseBio Pharma granted EMA PRIME designation for antiplatelet drug

PhaseBio Pharmaceuticals (NASDAQ:PHAS) received the EMA’s priority medicines, or PRIME, designation for PB2452, a drug designed to reverse the effects of antiplatelet drug, ticagrelor. Ticagrelor is administered...

February 11, 2020

Feature

Ripple Therapeutics pursues financing for Phase 2 intravitreal implant trial and Epidel platform expansion

Closely-held Ripple Therapeutics, a recent spinout from Interface Biologics, is pursuing a $25-million series A financing to complete a Phase 2 trial of IBE-814 IVT, a dexamethasone prodrug intravitreal implant, and...

February 11, 2020

Developments

Myovant reports 88% one-year response rate in Phase 3 relugolix extension study

Myovant Sciences (NASDAQ:MYOV) reported that its Phase 3 extension study of once-daily relugolix, in combination with estradiol and norethindrone acetate, achieved a one-year 88% response rate in women with uterine...

February 10, 2020

Developments

vTv Therapeutics’ Phase 2 diabetes trial meets primary objective

vTv Therapeutics’ (NASDAQ:VTVT) Phase 2 trial of TTP399 in Type 1 diabetes (T1D) patients met its primary objective by demonstrating statistically significant improvements in HbA1c compared to placebo. The company...

February 10, 2020

Developments

Catalyst Biosciences reports positive Phase 2b data from hemophilia trial

Catalyst Biosciences (NASDAQ:CBIO) reported positive results from its Phase 2b trial of DalcA, a subcutaneously administered Factor IX (FIX) therapy for the treatment of hemophilia B. The study was designed to evaluate...

February 7, 2020

Developments

Soricimed reports first cohort completion in Phase 1b trial of SOR-C13

Closely-held Soricimed Biopharma reported that the MD Anderson Cancer Center completed the first cohort in its investigator-initiated trial of Soricimed’s SOR-C13. The trial, launched in September 2019, is building on...

February 7, 2020

Developments

Hepion elucidates CRV431’s mechanism of action in NASH

Hepion Pharmaceuticals (NASDAQ:HEPA) released a video illustrating CRV431’s mechanism of action in non-alcoholic steatohepatitis (NASH). CRV431 inhibits multiple forms of cyclophilins to impact multiple stages of NASH...

February 4, 2020

Executive Moves

Verona Pharma announces senior management changes

Verona Pharma (NASDAQ:VRNA) has appointed David Zaccardelli as president, CEO, and director; and Mark Hahn as CFO. Mr. Zaccardelli will replace current CEO, Jan-Anders Karlsson, who is retiring. Mr. Zaccardelli...

February 3, 2020

Developments

Anavex gets fast track designation for Rett Syndrome drug candidate

The FDA granted fast track designation to Anavex Life Sciences’ (NASDAQ:AVXL) ANAVEX2-73 for the treatment of Rett syndrome. Rett syndrome is a genetic neurodevelopmental disorder characterized by severe physical and...

February 3, 2020

Author - Abby Hardy

PAVmed subsidiary gets breakthrough device designation for esophageal DNA test

PhaseBio Pharma granted EMA PRIME designation for antiplatelet drug

Ripple Therapeutics pursues financing for Phase 2 intravitreal implant trial and Epidel platform expansion

Myovant reports 88% one-year response rate in Phase 3 relugolix extension study

vTv Therapeutics’ Phase 2 diabetes trial meets primary objective

Catalyst Biosciences reports positive Phase 2b data from hemophilia trial

Soricimed reports first cohort completion in Phase 1b trial of SOR-C13

Hepion elucidates CRV431’s mechanism of action in NASH

Verona Pharma announces senior management changes

Anavex gets fast track designation for Rett Syndrome drug candidate

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