BC Extra | May 21, 2019
Clinical News

BioCryst makes case for oral HAE therapy even as Phase III data disappoint investors

Despite reporting Phase III efficacy data for its oral hereditary angioedema therapy that fell short of marketed injectable therapies to prevent HAE attacks, BioCryst believes the demand for an oral option will enable BCX7353 to...
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...
BC Week In Review | 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 for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20...
BC Extra | 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 for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20...
BC Week In Review | 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...
BC Extra | 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 | Aug 4, 2018
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...
BC Week In Review | 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....
BC Extra | 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 27, 2018
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...
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