23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
18:35 , Dec 14, 2018 |  BC Week In Review  |  Clinical News

Syros' SY-1425 plus Vidaza leads to 63% ORR in biomarker-positive AML cohort

Syros Pharmaceuticals Inc. (NASDAQ:SYRS) reported Phase II data from a cohort of eight evaluable newly diagnosed, biomarker-positive acute myelogenous leukemia (AML) patients showing that tamibarotene (SY-1425) plus Vidaza azacitidine from Celgene Corp. (NASDAQ:CELG) led to...
14:42 , Dec 11, 2018 |  BC Innovations  |  Distillery Therapeutics

Inflammation

INDICATION: Inflammatory disease Cell culture studies suggest combined inhibition of BRD4 and HDAC could help treat type I interferon-driven diseases. In fibroblasts from patients deficient in the type I interferon regulators ISG15 or USP18, a...
18:25 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

On heels of Sobi deal, Novimmune's emapalumab gets FDA approval

FDA approved Gamifant emapalumab-lzsg from Novimmune S.A. (Plan-les-Ouates, Switzerland), giving Novimmune a Priority Review voucher and the first U.S.-approved drug for hemophagocytic lymphohistiocytosis (HLH). Novimmune said it plans to sell the Priority Review voucher. The...
20:05 , Nov 26, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Melanoma Mouse studies suggest inhibiting IFNγ receptor could help treat melanoma. In a mouse model of melanoma, lymphatic endothelial cell-specific knockout of IFNγ receptor decreased tumor growth compared with normal IFNγ expression. In another...
20:53 , Nov 20, 2018 |  BC Extra  |  Company News

On heels of Sobi deal, Novimmune's emapalumab gets FDA approval

FDA approved Gamifant emapalumab-lzsg from Novimmune S.A. (Plan-les-Ouates, Switzerland), giving Novimmune a Priority Review voucher and the first U.S.-approved drug for hemophagocytic lymphohistiocytosis (HLH). The approval comes just four months after Swedish Orphan Biovitrum AB...
03:21 , Nov 17, 2018 |  BioCentury  |  Product Development

Betting Combos on Biomarkers

Despite lackluster monotherapy data at SITC from the latest tranche of immunotherapy candidates, drug developers are moving into combination trials with PD-1 and PD-L1 inhibitors based on biomarkers of pharmacodynamic activity. Results from the next...
19:59 , Nov 16, 2018 |  BioCentury  |  Tools & Techniques

Benchtop manufacturing gets smaller

Publisher’s note: This story originally ran in the Nov. 15, 2018 issue of BioCentury Innovations , a comprehensive source of developments in translational research with knowledgeable perspectives on the key innovations, trends and opportunities in...
19:13 , Nov 16, 2018 |  BC Week In Review  |  Company News

Sobi springboards U.S. growth in deal for AZ's Synagis

Swedish Orphan Biovitrum AB (SSE:SOBI) obtained U.S. rights to commercialize infectious disease drug Synagis palivizumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) for $1.5 billion up front. Sobi called the deal, which also includes profit sharing with...
01:14 , Nov 16, 2018 |  BC Innovations  |  Emerging Company Profile

Virion: Harnessing viral defects

Virion Biotherapeutics Ltd. has capitalized on a naturally occurring viral mutation to develop broad-spectrum antivirals with lower potential for resistance than marketed products. Its lead compound, VH244, is in preclinical development to treat respiratory infections...