BC Extra | Jul 24, 2019
Company News

July 23 Company Quick Takes: FDA approves Pfizer’s Rituxan biosimilar; plus Intra-Cellular, OTC Tamiflu, Cimzia and more

Pfizer’s Rituxan biosimilar approved in U.S.  FDA approved Ruxience rituximab-pvvr from Pfizer Inc. (NYSE:PFE) for non-Hodgkin lymphoma, chronic lymphocytic leukemia and granulomatosis with polyangitis and microscopic polyangitis. Ruxience is the second biosimilar of Rituxan, an...
BC Week In Review | Apr 26, 2019
Clinical News

Lilly planning submissions for Taltz in non-radiographic axial spondyloarthritis

Lilly said it plans to submit regulatory applications this year for Taltz ixekizumab to treat non-radiographic axial spondyloarthritis after the drug met the primary and all major secondary endpoints in the Phase III COAST-X trial....
BC Week In Review | Apr 5, 2019
Company News

Cimzia approved for non-radiographic axial spondyloarthritis

FDA approved Cimzia certolizumab pegol to treat non-radiographic axial spondyloarthritis. FDA said the drug, from UCB S.A. (Euronext:UCB), is the first approved for the indication. Cimzia, a pegylated humanized antibody fragment against TNFα, is also...
BioCentury | Jan 5, 2019

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Week In Review | Aug 3, 2018
Clinical News

UCB's Cimzia meets in Phase III for non-radiographic axial spondyloarthritis

UCB S.A. (Euronext:UCB) reported in May that Cimzia certolizumab pegol met the primary endpoint in the Phase III C-AXSPAND trial to treat non-radiographic axial spondyloarthritis. Cimzia significantly improved the proportion of patients achieving an Ankylosing...
BC Extra | Jul 12, 2018
Politics & Policy

ICER panel votes against elagolix for endometriosis

An ICER panel showed little confidence in the clinical effectiveness of elagolix (ABT-620) from AbbVie Inc. (NYSE:ABBV) to treat endometriosis, voting Thursday that evidence is not adequate to support a net health benefit over other...
BioCentury | Jan 6, 2018

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BioCentury | Jul 7, 2017

Onward and upward

The top three market cap tiers continued to outperform smaller caps in 2Q17, led by companies valued between $1 billion and $9.9 billion. Companies valued below $1 billion failed to carry over their momentum from...
BC Week In Review | Apr 28, 2017
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...
BC Extra | Apr 24, 2017
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...
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