Clinical Intelligence

OncoGenex to initiate phase II trial of OGX-427 in non-squamous NSCLC

Friday, April 12, 2013 12:17 PM

OncoGenex Pharmaceuticals, a biopharmaceutical company, plans to initiate an investigator-sponsored, randomized, double-blind, placebo-controlled phase II study, Spruce, evaluating OGX-427 in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC). The trial will investigate whether adding OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival (PFS) outcomes.

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AstraZeneca touts top-line results from OSKIRA-1 phase III study of fostamatinib in RA

Friday, April 5, 2013 12:33 PM

AstraZeneca released top-line results of OSKIRA-1, a phase III study to assess the efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for rheumatoid arthritis (RA). OSKIRA-1 had two primary endpoints: assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified Total Sharp Score).

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FDA approves Janssen’s Invokana for type 2 diabetes

Monday, April 1, 2013 02:15 PM

The FDA has approved Janssen Pharmaceuticals’ Invokana (canagliflozin) for the treatment of adults with type 2 diabetes.

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The CenterWatch Monthly, April 2013

Monday, April 1, 2013 10:19 AM

20 Innovators Changing the Face of the Clinical Trials Industry

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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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