00:48 , May 17, 2019 |  BC Innovations  |  Tools & Techniques

Leaning on exosomes, model-informed drug development gets closer to tailoring doses to each patient

Model-informed drug development is poised to move into personalized dosing, with a little help from exosomes. An August FDA workshop aims to shed light on when and how to use these precision dosing models in...
00:18 , Dec 20, 2017 |  BC Extra  |  Company News

Management tracks: Intellia, Spectrum

Gene editing company Intellia Therapeutics Inc. (NASDAQ:NTLA) said CEO Nessan Bermingham will resign, effective Jan. 1. EVP of R&D John Leonard will succeed Bermingham. Hematology and cancer company Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said CEO Rajesh...
17:55 , Apr 28, 2017 |  BC Week In Review  |  Clinical News

Cimzia regulatory update

UCB said FDA issued a complete response letter in March to an sBLA for Cimzia certolizumab pegol to treat polyarticular juvenile idiopathic arthritis, citing concerns regarding the reliability of submitted pharmacokinetic data. The company said...
20:10 , Apr 24, 2017 |  BC Extra  |  Company News

UCB reveals CRL for Cimzia

UCB S.A. (Euronext:UCB) revealed in its 1Q17 earnings report that FDA issued a complete response letter last month for Cimzia certolizumab pegol to treat polyarticular juvenile idiopathic arthritis. UCB said the letter concerns the reliability...
08:00 , Feb 22, 2016 |  BioCentury  |  Regulation

Extrapolating mAbs

FDA's Arthritis Advisory Committee's discussion and vote to recommend approval of the first biosimilar mAb shows that the mechanism of action of the reference product matters, and companies with biosimilars of mAbs approved for multiple...
08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Enclomiphene citrate regulatory update

FDA issued a complete response letter to Repros for enclomiphene to treat secondary hypogonadism in overweight men wishing to restore normal testicular function. According to Repros, FDA stated that “based on recent scientific developments,” the...
08:00 , Nov 9, 2015 |  BC Week In Review  |  Clinical News

Enclomiphene citrate regulatory update

FDA cancelled the Nov. 3 meeting of its Bone, Reproductive and Urologic Products Advisory Committee to discuss an NDA from Repros for enclomiphene to treat secondary hypogonadism in overweight men. Repros said the cancellation is...
00:55 , Sep 19, 2015 |  BC Extra  |  Clinical News

Versartis gains on GHD results

Versartis Inc. (NASDAQ:VSAR) gained $2.16 (20%) to $13.14 after reporting 18-month data from a long-term extension study of somavaratan ( VRS-317 ), a long-acting recombinant human growth hormone (rhGH), in pre-pubertal children with growth hormone...
07:00 , Jul 27, 2015 |  BC Week In Review  |  Clinical News

VRS-317: Phase III ongoing

Versartis will resume enrolling U.S. patients in the open-label, international Phase III VELOCITY trial after FDA lifted a partial clinical hold on VRS-317. The company said it had submitted additional bioanalytical data to FDA and...
00:13 , Jul 7, 2015 |  BC Extra  |  Top Story

Versartis rises after FDA removes clinical hold

Versartis Inc. (NASDAQ:VSAR) gained $4.30 (29%) to $18.92 on Monday after FDA lifted a partial clinical hold on the Phase III VELOCITY study of VRS-317 , a long-acting recombinant human growth hormone (rhGH) to treat...