19:29 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks...
23:38 , Oct 19, 2018 |  BC Extra  |  Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP recommended several approvals Friday, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE....
23:17 , Oct 3, 2018 |  BC Innovations  |  Translation in Brief

New Therapeutic Targets and Biomarkers: September 2018

New Therapeutic Targets and Biomarkers: September 2018 Select top therapeutic targets and biomarkers covered by BioCentury or added to the BCIQ database in September. Therapeutic targets are defined as any protein, gene or other molecule...
17:37 , Sep 26, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Head and neck cancer In vitro and cell culture studies identified a depsipeptide-based covalent KLK6 inhibitor that could help treat head and neck cancer. High throughput screening of a library of 80,000 small molecules,...
16:42 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

BioCryst's oral HAE candidate reduces attack symptom severity in Phase II

BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) reported data from 33 evaluable patients treated for a total of 95 acute attacks of hereditary angioedema (HAE) in the Phase II ZENITH-1 trial showing that a single 750 mg dose...
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...
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...
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...
23:43 , May 31, 2018 |  BC Innovations  |  Emerging Company Profile

Oral route for HAE

The team behind Firazyr icatibant has reunited to develop an oral version of the drug that could give hereditary angioedema patients the alternative to injectables they’ve been asking for. Pharvaris B.V. brings together team members...