BioCentury | Oct 6, 2018
Finance

Large cap comeback

...options are inadequate Pharming Group N.V. (Euronext:PHARM) FDA issues a complete response letter for Ruconest conestat alfa...
BioCentury | Sep 21, 2018
Clinical News

FDA wants extra trial for Pharming's Ruconest as HAE Prophylactic

...Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic...
...Sept. 19, declined to provide a timeline for a resubmission. The additional trial will evaluate Ruconest...
...Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Ruconest conestat alfa Business: Inflammation Jennie Walters Rhucin, Ruconest, conestat alfa (rhc1inh...
BioCentury | Sep 19, 2018
Company News

FDA wants extra trial for Pharming's Ruconest as HAE prophylactic

...Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic...
...€0.77 Wednesday, declined to provide a timeline for a resubmission. The additional trial will evaluate Ruconest...
...C1 esterase inhibitor, to treat acute HAE attacks in adults and adolescents. Jennie Walters Rhucin, Ruconest, conestat alfa (rhc1inh...
BioCentury | Nov 30, 2017
Clinical News

Pharming reports Phase II data for Ruconest in HAE in pediatric patients

...hereditary angioedema (HAE) in a Phase II trial showing that 50 IU/kg IV Ruconest conestat alfa (rhC1INH...
...endpoints include time to beginning of relief, minimal symptoms and complete resolution, pharmacokinetics and pharmacodynamics. Ruconest...
...in the U.S. for HAE. Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Ruconest conestat alfa (rhC1INH...
BioCentury | Oct 13, 2017
Regulation

Expanding the HAE tool kit

...Berinert P have reduced attack severity in patients with abdominal, peripheral and laryngeal swelling. Ruconest conestat alfa...
...patients with laryngeal attacks, but has reduced the severity of abdominal and peripheral HAE attacks. Ruconest...
BioCentury | Aug 22, 2016
Company News

Valeant Pharmaceuticals, Pharming deal

...up to $65 million in sales milestones to reacquire North American commercialization rights to Ruconest conestat alfa...
BioCentury | Aug 8, 2016
Clinical News

Ruconest conestat alfa: Phase II data

...with a history of >=4 attacks per month showed that once- and twice-weekly 50 IU/kg Ruconest...
...p<0.0001). Additionally, 74% of patients receiving twice-weekly Ruconest had a >=50% reduction in attack frequency. Ruconest...
...to Ruconest from Pharming. Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Ruconest conestat alfa ( rhC1INH...
BioCentury | Apr 25, 2016
Clinical News

Ruconest conestat alfa regulatory update

...The European Commission approved an expanded label for Ruconest conestat alfa from Pharming to treat acute angioedema...
...also removed the requirement to test patients for pre-existing antibodies against rabbit dander prior to Ruconest...
...Ruconest in the EU. Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Ruconest conestat alfa ( rhC1INH...
BioCentury | Mar 7, 2016
Clinical News

Ruconest conestat alfa regulatory update

...EMA’s CHMP recommended expanding the label of Ruconest conestat alfa from Pharming to treat acute angioedema attacks...
...recommended removing the requirement to test patients for pre-existing antibodies against rabbit dander prior to Ruconest...
...Ruconest in the EU. Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Ruconest conestat alfa ( rhC1INH...
BioCentury | Feb 8, 2016
Clinical News

Ruconest conestat alfa: Completed Phase II enrollment

...international Phase II trial evaluating 50 IU/kg Ruconest once or twice weekly in 4-week periods. Ruconest...
...acute attacks of HAE. Pharming Group N.V. (Euronext:PHARM), Leiden, the Netherlands Product: Ruconest conestat alfa ( rhC1INH...
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