BioCentury | Jan 25, 2019
Finance

Venrock spreads HAE bets

Venrock is broadening its portfolio of oral hereditary angioedema therapy investments by leading a $23 million series B round that will allow Attune Pharmaceuticals to move its lead plasma kallikrein (KLKB1) inhibitor into Phase II...
BioCentury | Aug 31, 2018
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...
BioCentury | Aug 23, 2018
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...
BioCentury | Mar 2, 2018
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....
BioCentury | Feb 23, 2018
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....
BioCentury | Jan 12, 2018
Company News

Shire to split neuro and rare disease businesses

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will split its neuroscience and rare disease businesses into two divisions. The separation comes after the pharma said in its 2Q17 earnings report that it was evaluating options for...
BioCentury | Jan 9, 2018
Company News

Shire splits neuro and rare disease businesses

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will split its neuroscience and rare disease businesses into two divisions. The separation comes after the pharma said in its 2Q17 earnings report that it was evaluating options for...
BioCentury | Aug 4, 2017
Company News

Shire evaluating neurology pipeline

In its 2Q17 earnings report, Shire plc (LSE:SHP; NASDAQ:SHPG) said it will evaluate options for its neurology franchise, with the potential of spinning out the company’s core ADHD business into an independent public company. The...
BioCentury | Aug 3, 2017
Company News

Shire evaluating neurology pipeline

In its 2Q17 earnings report, Shire plc (LSE:SHP; NASDAQ:SHPG) said it will evaluate options for its neurology franchise, with the potential of spinning out the company’s core ADHD business into an independent public company. The...
BioCentury | May 19, 2017
Clinical News

Shire HAE treatment from Dyax deal clears Phase III hurdle

Shire plc (LSE:SHP; NASDAQ:SHPG) will submit a BLA to FDA by early next year for subcutaneous lanadelumab (SHP643) to prevent hereditary angioedema (HAE) attacks after the compound met the primary endpoint in the Phase III...
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BioCentury | Jan 25, 2019
Finance

Venrock spreads HAE bets

Venrock is broadening its portfolio of oral hereditary angioedema therapy investments by leading a $23 million series B round that will allow Attune Pharmaceuticals to move its lead plasma kallikrein (KLKB1) inhibitor into Phase II...
BioCentury | Aug 31, 2018
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...
BioCentury | Aug 23, 2018
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...
BioCentury | Mar 2, 2018
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....
BioCentury | Feb 23, 2018
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....
BioCentury | Jan 12, 2018
Company News

Shire to split neuro and rare disease businesses

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will split its neuroscience and rare disease businesses into two divisions. The separation comes after the pharma said in its 2Q17 earnings report that it was evaluating options for...
BioCentury | Jan 9, 2018
Company News

Shire splits neuro and rare disease businesses

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will split its neuroscience and rare disease businesses into two divisions. The separation comes after the pharma said in its 2Q17 earnings report that it was evaluating options for...
BioCentury | Aug 4, 2017
Company News

Shire evaluating neurology pipeline

In its 2Q17 earnings report, Shire plc (LSE:SHP; NASDAQ:SHPG) said it will evaluate options for its neurology franchise, with the potential of spinning out the company’s core ADHD business into an independent public company. The...
BioCentury | Aug 3, 2017
Company News

Shire evaluating neurology pipeline

In its 2Q17 earnings report, Shire plc (LSE:SHP; NASDAQ:SHPG) said it will evaluate options for its neurology franchise, with the potential of spinning out the company’s core ADHD business into an independent public company. The...
BioCentury | May 19, 2017
Clinical News

Shire HAE treatment from Dyax deal clears Phase III hurdle

Shire plc (LSE:SHP; NASDAQ:SHPG) will submit a BLA to FDA by early next year for subcutaneous lanadelumab (SHP643) to prevent hereditary angioedema (HAE) attacks after the compound met the primary endpoint in the Phase III...
Items per page:
1 - 10 of 567