Clinical Intelligence

Shionogi announces positive results for Cefiderocol pivotal cUTI trial

Tuesday, January 17, 2017

Shionogi has announced that cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, met the FDA pre-specified primary endpoint for non-inferiority vs imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with Gram-negative bacteria. Cefiderocol was superior to IPM/CS at test of cure (TOC).

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RedHill RHB-104 gets FDA QIDP for Nontuberculous Mycobacteria Infections

Thursday, January 12, 2017

RedHill Biopharma, a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, has announced that RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections.

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FDA accepts Mylan, BioCon’s biosimilar trastuzumab BLA

Thursday, January 12, 2017

Mylan and Biocon has announced that the FDA accepted Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.

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FDA approves Genentech’s Lucentis for myopic choroidal neovascularization

Wednesday, January 11, 2017

Genentech, a member of the Roche Group, announced that the FDA has approved Lucentis (ranibizumab injection) 0.5mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.

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TLC Biopharmaceuticals reports results of phase I/II tlc599 osteoarthritis trial

Wednesday, January 11, 2017

TLC has reported top-line results from the phase I/II trial of TLC599 for sustained pain management in patients with osteoarthritis of the knee. The trial demonstrated a positive safety profile for a single intra-articular injection of either a 6mg or 12mg dose of TLC599. In addition, the trial demonstrated a trend of sustained, clinically meaningful decrease from baseline through week 12 in several widely-used assessments of pain. These results support the potential for TLC599 to address the problem of a limited duration of action for steroid therapy in patients with osteoarthritis. 

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