Category - Developments

Developments

Kiniksa Pharma’s rilonacept gets FDA breakthrough therapy designation for pericarditis

The FDA granted Kiniksa Pharmaceuticals’ (NASDAQ:KNSA) rilonacept breakthrough therapy designation for the treatment of recurrent pericarditis. Rilonacept is a recombinant fusion protein that blocks inflammatory...

November 20, 2019

Developments

T2 Biosystems receives CE Mark for T2Resistance panel

T2 Biosystems (NASDAQ:TTOO) was granted a CE Mark for its T2Resistance panel, a diagnostic that identifies 13 of the most serious resistance genes on the Centers for Disease Control and Prevention’s antibiotic...

November 20, 2019

Developments

Study finds invasive prostate cancer incidence rising among young men

The incidence of prostate cancer among adolescents and young adults has increased in the U.S. and many other countries during the past three decades, in direct contrast to older men, according to study results published...

November 20, 2019

Developments

EMA grants Achillion danicopan PRIME designation

Achillion Pharmaceuticals’ (NASDAQ:ACHN) danicopan received the European Medicines Agency’s (EMA) priority medicines, or PRIME, designation for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The EMA’s...

November 19, 2019

Developments

Myovant Sciences relugolix meets primary endpoint in Phase 3 prostate cancer trial

Myovant Sciences’ (NASDAQ:MYOV) oral gonadotropin-releasing hormone receptor antagonist, relugolix, met its primary efficacy endpoint in a Phase 3 trial of men with advanced prostate cancer. In the HERO study, nearly...

November 19, 2019

Developments

Ladenburg Thalmann and Advisor Group in merger pact

Ladenburg Thalmann Financial Services (NYSE American:LTS) and Advisor Group entered into a definitive merger agreement to create a wealth management industry leader with nearly 11,500 financial advisors and more than...

November 19, 2019

Developments

Liminal presents new preclinical data for PBI-4050 on PAH

Liminal BioSciences (NASDAQ:LMNL; TSX:LMNL) presented two scientific posters with new preclinical data for its PBI-4050 drug candidate and the treatment of pulmonary arterial hypertension (PAH) at the American Heart...

November 19, 2019

Developments

Orchard Therapeutics gets EMA accelerated assessment for OTL-200

The EMA granted Orchard Therapeutics’ (NASDAQ:ORTX) OTL-200 accelerated assessment for the treatment of metachromatic leukodystrophy (MLD). MLD is caused by a mutation in the arylsulfatase-A gene, which results in the...

November 18, 2019

Developments

Caladrius Biosciences reports positive data from coronary microvascular dysfunction study

Caladrius Biosciences (NASDAQ:CLBS) reported positive results from its proof-of-concept study of CLBS16 for the treatment of coronary microvascular dysfunction (CMD). CMD is a non-obstructive coronary artery disease...

November 18, 2019

Developments

Axovant gets FDA orphan drug designation for gangliosidosis gene therapy

Axovant Gene Therapies (NASDAQ:AXGT) received FDA orphan drug designation for AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a rare genetic disease where mutations in the GLB1 gene impair...

November 18, 2019

Category - Developments

Kiniksa Pharma’s rilonacept gets FDA breakthrough therapy designation for pericarditis

T2 Biosystems receives CE Mark for T2Resistance panel

Study finds invasive prostate cancer incidence rising among young men

EMA grants Achillion danicopan PRIME designation

Myovant Sciences relugolix meets primary endpoint in Phase 3 prostate cancer trial

Ladenburg Thalmann and Advisor Group in merger pact

Liminal presents new preclinical data for PBI-4050 on PAH

Orchard Therapeutics gets EMA accelerated assessment for OTL-200

Caladrius Biosciences reports positive data from coronary microvascular dysfunction study

Axovant gets FDA orphan drug designation for gangliosidosis gene therapy

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