Clinical Intelligence

Novartis’s LDK378 receives FDA Breakthrough Therapy designation for ALK+ non-small cell lung cancer

Monday, March 18, 2013 11:30 AM

The FDA has granted Novartis’ investigational compound LDK378 Breakthrough Therapy designation for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during treatment with, or were intolerant to, crizotinib.

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FDA grants Fast Track to Chimerix’s CMX001 for cytomegalovirus infection

Wednesday, March 13, 2013 12:06 PM

The FDA has granted Fast Track designation for CMX001 for the prevention of cytomegalovirus (CMV) infection, according to Chimerix, the drug’s developer. CMX001 is the company's broad spectrum, oral nucleotide analog lipid-conjugate that blocks replication of double-stranded DNA (dsDNA) viruses.

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Telormedix enrolls first patient in phase II bladder cancer trial

Monday, March 11, 2013 12:05 PM

Telormedix, a Switzerland-based clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, has recruited the first patient in a phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.

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The CenterWatch Monthly, March 2013

Friday, March 1, 2013 08:00 AM

Sites rate the best sponsors 2013

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BioElectronics expands clinical research

Thursday, February 28, 2013 02:30 PM

Frederick, Md.-based BioElectronics, a maker of consumer medical devices for pain and healing, has initiated a series of new clinical trials.

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Neovasc's COSIRA clinical trial protocol to be published in peer-reviewed journal

Thursday, February 28, 2013 02:27 PM

Vancouver-based Neovasc said the clinical protocol for its COSIRA (coronary sinus reducer for treatment of refractory angina) trial has been published in the peer-reviewed journal Trials. COSIRA is a double-blind, randomized, multi-center trial further assessing the efficacy and safety of the Neovasc Reducer, a novel percutaneous device for the treatment of refractory angina.  The COSIRA trial is currently enrolling patients in the U.K., Europe and  Canada. 

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KaloBios touts phase I/II results of KB002 in persistent asthma

Thursday, February 28, 2013 08:00 AM

KaloBios Pharmaceuticals reported data from its phase I/II study in persistent asthma for KB002 (precursor chimeric anti-GM-CSF monoclonal antibody to KB003).

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Bayer's Stivarga receives FDA approval for GIST

Tuesday, February 26, 2013 12:27 PM

The FDA has approved Bayer's Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

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Neurovance receives patent for EB-1020, initiates ADHD trial

Friday, February 22, 2013 01:59 PM

The United States Patent and Trademark Office (USPTO) has issued Neurovance, a Cambridge, Mass.-based company spun out of Euthymics Bioscience, a notice of allowance for a composition of matter patent for EB-1020, providing proprietary protection for EB-1020 through July 2026.

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FDA approves new treatment for late-stage breast cancer

Friday, February 22, 2013 12:41 PM

The FDA has approved Genentech’s Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.

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