Clinical Intelligence

FDA grants Tengion Orphan Drug designation

Friday, June 10, 2011 11:57 AM

Tengion, based in East Norriton, Penn., said the FDA has granted Orphan Drug designation to the company's Neo-Urinary Conduit, for treatment of bladder dysfunction requiring incontinent urinary diversion. 

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Clinilabs selected for phase II study

Friday, June 10, 2011 11:53 AM

New York-based CRO Clinilabs has been selected to conduct a phase II clinical research study of an investigational medication in patients with Major Depressive Disorder.

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The CenterWatch Monthly, June 2011

Wednesday, June 1, 2011 01:51 PM

Sites rate Novo Nordisk, Roche, Amgen on top

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Medicago collaborates with U.S. Army Medical Research Institute of Infectious Diseases for Ebola vaccine

Friday, May 27, 2011 11:20 AM

Medicago, a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and virus-like particles (VLPs), has entered  into a research collaboration agreement with the U.S. Army Medical  Research Institute of Infectious Diseases (USAMRIID) for the  development of a plant-based VLP vaccine candidate for the prevention of Ebola. Ebola is a very serious hemorrhagic fever virus for which no licensed treatment or vaccine exists.

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Tigris enrolls first patient in breast cancer study

Friday, May 27, 2011 10:38 AM

Tigris Pharmaceuticals has enrolled its first patient in a randomized phase 2 clinical trial of AFP-464 (aminoflavone prodrug) with or without Faslodex (fulvestrant) in estrogen receptor (ER)-positive breast cancer patients. Molecular profiling will be used to pre-screen patients for a biomarker called Aryl Hydrocarbon Receptor (AhR), which has shown to predict sensitivity to AFP-464.

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Onyx Pharmaceuticals has pivotal carfilzomib phase IIb data

Friday, May 20, 2011 11:13 AM

Onyx Pharmaceuticals has updated results from the phase IIb 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

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Medivir presents positive results from ASPIRE phase IIb study for HCV

Friday, May 20, 2011 11:11 AM

Medivir, a research-based specialty pharmaceutical company focused on infectious diseases, has results from the ASPIRE phase IIb study that evaluates the addition of once daily TMC435 to pegylated interferon and ribavirin in patients with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon (PegIFN) and ribavirin (RBV) was unsuccessful either because they relapsed, had a partial response or had a null response.

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Amsterdam Molecular Therapeutics shows data supporting role of chylomicron clearance as marker for Glybera efficacy

Friday, May 20, 2011 11:10 AM

Amsterdam Molecular Therapeutics, a company involved in the field of human gene therapy, has results from a long-term efficacy study of Glybera (alipogene tiparvovec) that showed improved chylomicron metabolism could be used as a biomarker for increased lipoprotein lipase (LPL) activity in those patients missing the gene that produces this protein. Glybera is a gene therapy product under development for the treatment of lipoprotein lipase deficiency (LPLD) that is currently under review for marketing approval with the EMA.

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Omeros advances OMS103HP and OMS302

Friday, May 20, 2011 10:49 AM

Omeros is advancing two of its product candidates from its PharmacoSurgery platform: OMS103HP for arthroscopic meniscectomy and OMS302 for intra-ocular lens replacement surgery; both candidates are going into phase III clinical development programs.  Additionally, the candidates have been added to standard irrigation solutions and delivered intra-operatively to the operative site throughout the surgical procedure to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to provide clinical benefits both during and after surgery.

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Allon Therapeutics enrolls for frontal dementia trial

Thursday, May 19, 2011 10:49 AM

Allon Therapeutics is currently enrolling patients in a phase 2/3 study for its lead neuroprotective drug candidate, davunetide, a treatment for progressive supranuclear palsy (PSP), a form of frontotemporal dementia (FTD). Allon has completed two phase 2a human efficacy studies for davunetide in patients with amnesic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease, and in patients with cognitive impairment associated with schizophrenia (CIAS).

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