19:37 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes in favor of Shire’s constipation product

FDA’s Gastrointestinal Drugs Advisory committee voted unanimously in favor of approving an NDA from Shire plc (LSE:SHP; NASDAQ:SHPG) for prucalopride to treat chronic idiopathic constipation (CIC). Its PDUFA date is Dec. 21. The panel voted 10-0...
18:38 , Oct 18, 2018 |  BC Innovations  |  Distillery Therapeutics

Endocrine/Metabolic

INDICATION: Porphyria In vitro, cell culture and mouse studies suggest ciclopirox could help treat congenital erythropoietic porphyria (CEP), which is caused by destabilizing mutations in UROS. Fragment-based screening, structural comparison of the top screening hits with...
20:38 , Oct 17, 2018 |  BC Innovations  |  Translation in Brief

Ciclopirox the chaperone

Atlas Molecular Pharma S.L. plans to repurpose antifungal drug ciclopirox to treat congenital erythropoietic porphyria after discovering it allosterically stabilizes an enzyme driving the disease. Atlas and colleagues from Center for Cooperative Research in Biosciences...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
03:53 , Sep 21, 2018 |  BC Innovations  |  Product R&D

China’s rising genomics start-ups

Behind bellwethers BGI Genomics Co. Ltd. and WuXi NextCode Genomics Inc., a new generation of Chinese genomics companies is emerging with ambitions to solve urgent problems, including early cancer detection and clinical trial recruitment, by...
06:31 , Aug 10, 2018 |  BC Week In Review  |  Company News

Luoxin gains Chinese rights to Trulance

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) granted Shandong Luoxin Pharmaceutical Group Stock Co. Ltd. (Linyi, China) exclusive rights to develop and commercialize gastrointestinal drug Trulance plecanatide in China, including Hong Kong and Macau. The license covers the...
19:36 , Aug 7, 2018 |  BC Extra  |  Company News

Luoxin gains Chinese rights to Trulance

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) granted Shandong Luoxin Pharmaceutical Group Stock Co. Ltd. (Linyi, China) exclusive rights to develop and commercialize gastrointestinal drug Trulance plecanatide in China, including Hong Kong and Macau. The license covers the...
17:21 , Jul 20, 2018 |  BC Week In Review  |  Company News

Roivant's China biotech reveals pipeline, pair of deals

Sinovant Sciences Ltd. (Shanghai, China) unveiled its pipeline, which contains four Phase III-ready assets, along with two new partnerships on July 17. Backed by Roivant Sciences GmbH (Basel, Switzerland) and Chinese private equity firm CITICPE, Sinovant...
16:13 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

Ironwood, Allergan start Phase IIIb of Linzess in IBS-C

Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) and Allergan plc (NYSE:AGN) began a double-blind, placebo-controlled, U.S. Phase IIIb trial to evaluate 290 µg Linzess linaclotide once daily in about 600 patients with irritable bowel syndrome with constipation (IBS-C). The...
21:55 , Jul 17, 2018 |  BC Extra  |  Company News

Roivant's China biotech reveals pipeline, pair of deals

Sinovant Sciences Ltd. (Shanghai, China) unveiled its pipeline, which contains four Phase III-ready assets, along with two new partnerships on a newsy Tuesday. Backed by Roivant Sciences GmbH (Basel, Switzerland) and Chinese private equity firm CITICPE,...