Abby Hardy, Author at BioTuesdays

Developments

Outlook Therapeutics completes enrollment in pivotal retinal disease trial

Outlook Therapeutics (NASDAQ:OTLK) completed patient enrollment in its pivotal clinical trial evaluating LYTENAVA, an ophthalmic formulation of bevacizumab, for use in retinal indications. Formerly known as ONS-5010...

July 7, 2020

Feature

Passage Bio developing transformative therapies for rare, life-threatening genetic disorders

Passage Bio (NASDAQ:PASG) is focused on developing transformative, differentiated therapies for rare, life-threatening monogenic CNS disorders, with the goal of mitigating development risk. “We believe that our rigorous...

June 30, 2020

Developments

Hepion advances to final dosing level in ongoing Phase 1 study of CRV431

Hepion Pharmaceuticals (NASDAQ:HEPA) advanced to the final dose level of CRV431 in its ongoing Phase 1 multiple ascending dose trial. The clinical trial management team determined the 300 mg dosing level to be safe and...

June 29, 2020

Developments

Iterum Therapeutics reports mixed topline results from Phase 3 sulopenem trial

Iterum Therapeutics (NASDAQ:ITRM) reported mixed topline results from its clinical trial assessing sulopenem, an anti-infective compound, in combination with probenecid for the treatment of uncomplicated urinary tract...

June 29, 2020

Developments

Kiniksa Pharma reports positive Phase 3 rilonacept data in pericarditis

Kiniksa Pharmaceuticals’ (NASDAQ:KNSA) rilonacept met its primary and major secondary efficacy endpoints in a Phase 3 recurrent pericarditis trial. The trial met its primary endpoint of time to pericarditis recurrence...

June 29, 2020

Developments

Orthofix FIREBIRD SI fusion system gets FDA clearance for low back pain

Orthofix Medical (NASDAQ:OFIX) received FDA clearance for its FIREBIRD SI fusion system and has treated its first patients for low back pain. The system is designed to compress and stabilize the sacroiliac (SI) joint...

June 29, 2020

Developments

Chiasma MYCAPSSA gets FDA approval for acromegaly

The FDA approved Chiasma’s (NASDAQ:CHMA) MYCAPSSA for the treatment of acromegaly, a rare, chronic disease characterized by the overproduction of growth hormone and insulin-like growth factor-1 hormone. MYCAPSSA...

June 26, 2020

Developments

Imara granted FDA orphan drug designation for the treatment of beta-thalassemia

The FDA granted Imara’s (NASDAQ:IMRA) IMR-687 orphan drug designation for the treatment of beta-thalassemia. Beta-thalassemia is a blood disorder characterized by reduced levels of hemoglobin. IMR-687 is small molecule...

June 24, 2020

Developments

Titan Pharma and Indegene sign Probuphine co-promotion partnership

Titan Pharmaceuticals (NASDAQ:TTNP) signed a co-promotion partnership with Indegene to establish multichannel digital marketing programs across the U.S. and engage health care providers (HCPs) who are eligible to...

June 24, 2020

Developments

Kane Biotech receives new funding from CanExport SMEs program

Kane Biotech (TSX-V:KNE; OTCQB:KNIBF) has been approved for up to $54,750 in funding from the Government of Canada’s CanExport small and medium-sized enterprises (SMEs) program. The program provides direct...

June 24, 2020

Author - Abby Hardy

Outlook Therapeutics completes enrollment in pivotal retinal disease trial

Passage Bio developing transformative therapies for rare, life-threatening genetic disorders

Hepion advances to final dosing level in ongoing Phase 1 study of CRV431

Iterum Therapeutics reports mixed topline results from Phase 3 sulopenem trial

Kiniksa Pharma reports positive Phase 3 rilonacept data in pericarditis

Orthofix FIREBIRD SI fusion system gets FDA clearance for low back pain

Chiasma MYCAPSSA gets FDA approval for acromegaly

Imara granted FDA orphan drug designation for the treatment of beta-thalassemia

Titan Pharma and Indegene sign Probuphine co-promotion partnership

Kane Biotech receives new funding from CanExport SMEs program

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