15:01 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

FDA approves Aeterna's Macrilen

FDA approved a resubmitted NDA for Macrilen macimorelin acetate (Macrimorelin-GHST, AEZS-130) from Aeterna Zentaris Inc. (TSX:AEZS; NASDAQ:AEZS) for use in diagnosing adult growth hormone deficiency (AGHD). Aeterna plans to launch the oral ghrelin-mimetic growth hormone...
20:17 , Dec 21, 2017 |  BC Extra  |  Company News

Aeterna jumps on Macrilen approval

Aeterna Zentaris Inc. (TSX:AEZS; NASDAQ:AEZS) shares climbed Thursday after FDA approved a resubmitted NDA for Macrilen macimorelin acetate for use in diagnosing adult growth hormone deficiency (AGHD). Aeterna added C$0.91 (35%) to C$3.48 in Toronto,...
03:08 , Dec 14, 2017 |  BC Innovations  |  Translation in Brief

Ghrelin’s LEAP forward

NGM and MedImmune researchers have discovered a liver peptide, LEAP2, that is a natural antagonist of the metabolic target ghrelin. The peptide could serve as a new handle for either boosting or dampening ghrelin signaling...
04:07 , Dec 8, 2017 |  BC Week In Review  |  Clinical News

EMA reviewing Aeterna Zentaris' Macrilen to evaluate AGHD

EMA accepted for review an MAA from Aeterna Zentaris Inc. (TSX:AEZS; NASDAQ:AEZS) for Macrilen macimorelin acetate (Macrimorelin-GHST, AEZS-130) to evaluate adult growth hormone deficiency (AGHD). A resubmitted NDA for the candidate is under FDA review...
16:44 , Aug 4, 2017 |  BC Week In Review  |  Clinical News

FDA accepts Aeterna's resubmitted NDA for GHD candidate Macrilen

FDA accepted for review a resubmitted NDA from Aeterna Zentaris Inc. (TSX:AEZS; NASDAQ:AEZS) for Macrilen macimorelin acetate (Macrimorelin-GHST, AEZS-130) to evaluate adult growth hormone deficiency (AGHD). Its PDUFA date is Dec. 30. FDA issued a...
19:26 , Jul 31, 2017 |  BC Innovations  |  Distillery Techniques

Imaging

TECHNOLOGY: PET A ghrelin -based PET imaging agent could help diagnose GHSR -expressing ovarian, prostate, testicular and other cancers. Chemical synthesis and in vitro testing of ghrelin analogs in competitive binding assays identified an eight...
19:39 , May 26, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends against Helsinn's Adlumiz

EMA’s CHMP recommended against approval of an MAA from Helsinn Healthcare S.A. (Lugano, Switzerland) for Adlumiz anamorelin (ONO-7643) to treat anorexia, cachexia or unintended weight loss in non-small cell lung cancer (NSCLC) patients. CHMP said...
18:51 , May 1, 2017 |  BC Extra  |  Clinical News

Aeterna scraps Zoptrex after endometrial cancer miss

Aeterna Zentaris Inc. (TSX:AEZS; NASDAQ:AEZS) said it will end development of Zoptrex zoptarelin doxorubicin (formerly AEZS-108) after it missed the primary endpoint in the Phase III ZoptEC trial to treat endometrial cancer. The compound failed...
22:30 , Mar 16, 2017 |  BC Innovations  |  Targets & Mechanisms

Bone appétit!

Last week’s Nature publication of a hormone secreted by bone that suppresses appetite and can curb weight gain not only adds to the emerging picture of bone as a player in the endocrine system but...
20:14 , Feb 10, 2017 |  BC Week In Review  |  Clinical News

Macrilen: Ph III data

Top-line data from about 110 patients with suspected AGHD and healthy volunteers in an open-label, 2-way crossover, international Phase III trial showed that a single oral dose of 0.5 mg/kg Macrilen missed the primary endpoint...