23:57 , Aug 22, 2019 |  BC Extra  |  Clinical News

After neurodegeneration miss, Retrophin looks to rebound with renal program

With plans to discontinue fosmetpantotenate after its Phase III miss, Retrophin President and CEO Eric Dube believes the $425 million with which it ended last quarter is enough to bring its remaining clinical candidate to...
19:45 , Aug 2, 2018 |  BC Extra  |  Politics & Policy

Corrigan departs FDA

Dara Corrigan is stepping down as acting deputy commissioner for FDA’s Office of Global Regulatory Operations and Policy, FDA told BioCentury. An FDA spokesperson said Mark Abdoo, assistant commissioner for the office, will fill the...
18:52 , Mar 15, 2018 |  BC Innovations  |  Tools & Techniques

Shared burden

Having learned their lesson with PD-L1, companies are collaborating on assay standards for tumor mutation burden -- a likely contender for the next major biomarker in immuno-oncology. A Friends of Cancer Research-led consortium of pharmas...
00:12 , Feb 28, 2017 |  BC Extra  |  Politics & Policy

Sklamberg departing FDA

Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg will leave the agency on March 3 "to pursue new opportunities.” News of his departure came in an agency-wide email from Acting Commissioner Stephen Ostroff...
01:00 , Feb 17, 2017 |  BC Innovations  |  Targets & Mechanisms

Gilding the Goldfinch

In launching Goldfinch Biopharma Inc. , Third Rock is extending its already heavy footprint in precision medicine into chronic kidney disease. The VC thinks the unfolding genetics in that field can yield disease-modifying therapies and...
07:00 , Sep 12, 2016 |  BC Week In Review  |  Clinical News

Sparsentan: Phase II data

Top-line combined data from the 3 sparsentan cohorts in the double-blind, international Phase II DUET trial in 96 evaluable patients with focal segmental glomerulosclerosis showed that once-daily oral sparsentan met the primary endpoint of reducing...
07:00 , Sep 7, 2016 |  BC Extra  |  Clinical News

Retrophin jumps on Phase II FSGS data

Retrophin Inc. (NASDAQ:RTRX) rose $4.49 (28%) to $20.81 on Wednesday after it said combined data from the three cohorts of the Phase II DUET study showed sparsentan ( RE-021 ) met the trial's primary endpoint...
07:00 , Jul 25, 2016 |  BioCentury  |  Strategy

Paving the way

Amgen Inc. and the Sandoz unit of Novartis AG are charting a course that could create competitive U.S. markets for two of the biggest prizes in the biosimilars universe, AbbVie Inc .'s Humira adalimumab and...
07:00 , Apr 11, 2016 |  BC Week In Review  |  Clinical News

Sparsentan: Completed Phase II enrollment

Retrophin completed enrollment of >100 patients in the double-blind, international Phase II DUET trial comparing 200, 400 and 800 mg oral RE-021 once daily for 8 weeks vs. once-daily oral irbesartan. Patients are eligible to...
07:00 , Mar 28, 2016 |  BC Week In Review  |  Company News

Cancer Genetics sales and marketing update

Cancer Genetics Inc. (NASDAQ:CGIX), Rutherford, N.J.   Business: Diagnostic   Cancer Genetics launched the CLIA-certified Focus::Oncomine assay to detect biomarkers in solid tumors. The next-generation sequencing (NGS) assay enables simultaneous DNA and RNA testing and...