Breaking News, Trials & Filings

Trials & Filings in Brief: Nov. 27, 2013

Mylan-Biocon, Cerecor, ARMO BioSciences, GSK, J&J, and more

Phase I
ARMO BioSciences has initiated Phase I trial of AM0010 in advanced solid tumors…read more

Threshold Pharmaceuticals posted early data from the Phase I portion of the investigator-sponsored Phase I/II trial of its investigational hypoxia-targeted drug TH-302 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma following bevacizumab failure … read more

Phase III
Cubist Pharmaceuticals Phase III trial of ceftolozane/tazobactam in complicated urinary tract infections (cUTI) met its primary endpoint of statistical non-inferiority compared to levofloxacin… read more

Sanofi and Regeneron Pharmaceuticals have announced results from the Phase III trial of sarilumab in adult patients with active rheumatoid arthritis (RA) who were inadequate responders to methotrexate (MTX) therapy… read more

Filings:
Mylan-Biocon gains approval of Trastuzumaba in India, a biosimilar to Roche’s Herceptin… read more

Cerecor’s CERC-301 was granted Fast Track designation for major depressive disorder (MDD)… read more

The FDA has approved GlaxoSmithKline’s pandemic flu vaccine for use in the event of an H5N1 bird flu epidemic… read more

The FDA has approved Johnson & Johnson’s Olysio ( assimeprevir) as a treatment for chronic hepatitis C virus infection… read more

The FDA has expanded the approved use of the cancer drug Nexavar to include late-stage differentiated thyroid cancer, the most common type of thyroid cancer… read more

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