Abby Hardy, Author at BioTuesdays

Developments

Kazia gets FDA rare pediatric disease designation for paxalisib

Kazia Therapeutics (NASDAQ:KZIA) received FDA rare pediatric disease designation for paxalisib for the treatment of diffuse intrinsic pontine glioma (DIPG). Paxalisib is currently in a Phase 1 trial for DIPG. Positive...

August 7, 2020

Executive Moves

Pacific Biosciences names Christian Henry as president and CEO

Christian Henry Pacific Biosciences (NASDAQ:PACB) appointed Christian Henry as president and CEO, effective Sept. 14. Mr. Henry will replace Michael Hunkapiller, who will retire at the end of 2020. Current...

August 7, 2020

Developments

Clovis enrolls first patient in Phase 2 portion of gynecologic cancer trial

Clovis Oncology (NASDAQ:CLVS) enrolled the first patient in the Phase 2 portion of its LIO-1 trial evaluating lucitanib for the treatment of gynecologic cancers. The trial is designed to evaluate the safety and efficacy...

August 6, 2020

Developments

FDA clears Surmodics’ Sublime dilatation catheter

Surmodics (NASDAQ:SRDX) received FDA 510(k) clearance for its Sublime radial access dilatation catheter. The company noted that at 250 cm, the Sublime catheter has the longest working length of currently available...

August 6, 2020

Developments

MediciNova reports positive results from Phase 2 alcohol use disorder trial

MediciNova (NASDAQ:MNOV) reported positive results from its Phase 2 trial evaluating ibudilast for the treatment of alcohol use disorder (AUD). Ibudilast has been marketed in Japan and Korea since 1989 to treat post...

August 6, 2020

Developments

Endologix gets CE Mark for ALTO abdominal stent graft system

Endologix (NASDAQ:ELGX) received a CE Mark for its ALTO abdominal stent graft system. ALTO is an endovascular aneurysm repair device designed to increase patient applicability and technical success rate, and improve...

August 5, 2020

Developments

Axsome AXS-12 gets FDA breakthrough therapy designation for narcolepsy

The FDA granted Axsome Therapeutics’ (NASDAQ:AXSM) AXS-12 breakthrough therapy designation for the treatment of cataplexy in patients with narcolepsy. Narcolepsy is a neurological condition characterized by excessive...

August 5, 2020

Developments

DBV Technologies gets FDA complete response letter for Viaskin Peanut

The FDA issued DBV Technologies (NASDAQ:DBVT) a complete response letter (CRL) regarding the company’s BLA for Viaskin Peanut, and epicutaneous patch to treat peanut allergies in children. The FDA identified concerns...

August 5, 2020

Developments

Eloxx Pharma ELX-02 granted FDA orphan drug designation for cystic fibrosis

Eloxx Pharmaceuticals’ (NASDAQ:ELOX) ELX-02 received FDA orphan drug designation for the treatment of cystic fibrosis (CF). ELX-02 is a small molecule designed to restore production of CF transmembrane conductance...

August 5, 2020

Developments

Hepion doses first patient with CRV431 in Phase 2 NASH study

Hepion Pharmaceuticals (NASDAQ:HEPA) dosed the first patient in its Phase 2 trial assessing CRV431 for the treatment of non-alcoholic steatohepatitis (NASH). The Phase 2a study, called AMBITION, is designed to assess...

August 5, 2020

Author - Abby Hardy

Kazia gets FDA rare pediatric disease designation for paxalisib

Pacific Biosciences names Christian Henry as president and CEO

Clovis enrolls first patient in Phase 2 portion of gynecologic cancer trial

FDA clears Surmodics’ Sublime dilatation catheter

MediciNova reports positive results from Phase 2 alcohol use disorder trial

Endologix gets CE Mark for ALTO abdominal stent graft system

Axsome AXS-12 gets FDA breakthrough therapy designation for narcolepsy

DBV Technologies gets FDA complete response letter for Viaskin Peanut

Eloxx Pharma ELX-02 granted FDA orphan drug designation for cystic fibrosis

Hepion doses first patient with CRV431 in Phase 2 NASH study

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