16:26 , Sep 21, 2018 |  BC Week In Review  |  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 for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20 (20%)...
18:24 , Sep 19, 2018 |  BC Extra  |  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 for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20 (20%)...
18:41 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

FDA approves Shire's Takhzyro, first mAb to prevent HAE

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA approved Takhzyro lanadelumab-flyo to prevent attacks of hereditary angioedema in patients ages 12 and older. The company said Takhzyro is the first mAb approved in the U.S. to prevent...
23:16 , Aug 23, 2018 |  BC Extra  |  Company News

FDA approves Shire’s Takhzyro, first mAb to prevent HAE

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA approved Takhzyro lanadelumab-flyo to prevent attacks of hereditary angioedema in patients ages 12 and older. The company said Takhzyro is the first mAb approved in the U.S. to prevent...
00:46 , Aug 4, 2018 |  BioCentury  |  Finance

Functions of formulation

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can...
21:02 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

Priority review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26. The...
22:09 , Feb 23, 2018 |  BC Extra  |  Company News

Priority Review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26. The...
02:03 , Jan 27, 2018 |  BioCentury  |  Finance

All together now

Promising proof-of-concept data from BioCryst Pharmaceuticals Inc. and a management team from Idera Pharmaceuticals Inc. with the requisite market know-how proved the right combination for a merger of two of the industry’s longest-standing independent small...
19:55 , Oct 13, 2017 |  BioCentury  |  Regulation

Expanding the HAE tool kit

Despite an increasingly crowded market, hereditary angioedema patients who attended FDA’s Patient-Focused Drug Development meeting said there remains room for improvement in dosing convenience and reducing attack frequency. Two subcutaneous prophylactics that have completed Phase...
19:16 , Sep 15, 2017 |  BC Week In Review  |  Clinical News

Shire's subcutaneous HAE candidate meets in Phase III

Shire plc (LSE:SHP; NASDAQ:SHPG) reported top-line data from the Phase III SAHARA trial in 75 patients ages 12 and older with symptomatic hereditary angioedema (HAE) showing that 2,000 IU SHP616 given every 3-4 days as...