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...
22:33 , Sep 11, 2017 |  BC Extra  |  Clinical News

Shire’s subcutaneous HAE candidate meets in Phase III

Shire plc (LSE:SHP; NASDAQ:SHPG) said SHP616 met the primary endpoint in the Phase III SAHARA trial to treat symptomatic hereditary angioedema in patients ages 12 and older. SHP616 is a lower-dose volume, subcutaneous liquid formulation...
19:28 , May 18, 2017 |  BC Extra  |  Clinical News

Shire HAE treatment from Dyax deal clears Phase III hurdle

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will submit a BLA to FDA by early next year for subcutaneous lanadelumab (SHP643) to prevent hereditary angioedema attacks. The company will base its submission on data from the...
21:45 , May 12, 2017 |  BioCentury  |  Strategy

Vertical vision

Shire plc’s deal with Parion Sciences Inc. is a step toward building vertically in ophthalmics, much like it has done in hereditary angioedema and hemophilia. On May 1, Shire gained exclusive, worldwide rights to P-321...
00:50 , Dec 20, 2016 |  BC Week In Review  |  Clinical News

Cinryze regulatory update

EMA’s CHMP recommended expanding the label of Cinryze from Shire for treatment and pre-procedure prevention of angioedema attacks to include children ages 2-11 with hereditary angioedema (HAE); and for routine prevention of attacks to include...
08:00 , Jan 18, 2016 |  BioCentury  |  Strategy

Shire's serial story

The most obvious benefits Shire plc expects to gain by acquiring Baxalta Inc. are a slew of new products and the cash to make subsequent acquisitions the company couldn't have made on its own. But...