Clinical Intelligence

FDA approves Biogen Idec’s Tecfidera for multiple sclerosis

Friday, March 29, 2013 01:44 PM

The FDA has approved Biogen Idec’s Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).

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Soligenix receives IND clearance from FDA for SGX942 in oral mucositis

Wednesday, March 27, 2013 08:59 AM

The FDA cleared the Soligenix’s Investigational New Drug (IND) application for SGX942 for the treatment of oral mucositis resulting from radiation and/or chemotherapy treatment in head and neck cancer patients.

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Teva, Active Biotech release results from 3-year ALLEGRO study in MS

Friday, March 22, 2013 11:48 AM

Teva Pharmaceutical Industries, a global pharmaceutical company, and Active Biotech, a biotechnology company with focus on autoimmune/inflammatory diseases and cancer, released today top-line results from the open-label extension of the phase III ALLEGRO study that assessed the progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients.

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Adocia announces its phase III program of BioChaperone for diabetic foot ulcer

Wednesday, March 20, 2013 01:26 PM

Adocia, a biotechnology company specializing in medicines from already approved therapeutic proteins, has announced the phase III development program of its product, BioChaperone PDGF-BB for the treatment of diabetic foot ulcer (DFU). The European Medicines Agency issued positive scientific advice for this program.

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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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