Clinical Intelligence

Isis earns $10 million milestone payment from Biogen Idec

Thursday, October 17, 2013 10:31 AM

Isis Pharmaceuticals has earned a $10 million milestone payment from Biogen Idec related to the selection and advancement of ISIS-DMPKRx to treat myotonic dystrophy type I (DM1).

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WIRB Copernicus Group

Novella Clinical selected by Scioderm to manage rare disease study

Thursday, October 17, 2013 09:01 AM

CRO Novella Clinical, a Quintiles company, has been selected by Scioderm, is a privately held, clinical-stage pharmaceutical company, to manage a phase IIb trial for the treatment of Epidermolysis Bullosa (EB), a rare genetic connective tissue condition. The trial will evaluate Scioderm’s investigational topical product, SD-101, for the treatment of skin blistering and erosions associated with this disease, including facilitation of healing of skin lesions and reduction of the incidence and/or severity of new lesions.

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CRF Health eCOA webinar series

Takeda, Sunovion present positive data for Schizophrenia treatment

Tuesday, October 15, 2013 10:39 AM

With educational financial support provided by Takeda and Sunovion Pharmaceuticals Europe, new data has been presented which shows both short and long-term efficacy for lurasidone, an atypical antipsychotic treatment for schizophrenia. These data also showed lurasidone to have early separation from placebo, a rapid onset of action, a favorable side effect profile and to be a well-tolerated, efficacious option for patients with schizophrenia switching medication. Lurasidone has been approved in U.S., Canada and Switzerland and currently is under regulatory review in Europe.

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Evotec receives preclinical milestone payment from Boehringer Ingelheim

Monday, October 14, 2013 09:30 AM

Evotec’s research alliance with Boehringer Ingelheim has reached a milestone in September triggering revenues of $5.4 million to Evotec. The milestone was for the transition of an oncology molecule into pre-clinical development.

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Ampio Pharmaceuticals announces positive results from Optina trial

Tuesday, October 8, 2013 09:00 AM

Ampio Pharmaceuticals, a development stage biopharmaceutical company, has announced interim results from the ongoing 450 patient, dose finding, 505(b)(2) study of Optina as a treatment for Diabetic Macular Edema (DME). This interim analysis was conducted by an Independent Data Review Committee (IDRC) comprised of a statistician and an ophthalmologist/retinologist, who were permitted to view the unmasked data from the trial. At least 30% of patients had reached the first four-week time point and their clinical results were considered representative data for the trial.

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Cardiome publishes positive data from atrial fibrillation study

Tuesday, October 8, 2013 08:30 AM

Cardiome Pharma has published positive data from an observational, retrospective study performed at the Skane University Hospital in Malmö, Sweden. The study included 251 recent-onset atrial fibrillation (AF) patients who received 355 BRINAVESS treatments between Jan. 15, 2011 and April 15, 2013. During the observation period, 70% of the AF patients treated with BRINAVESS converted with a median time of 11 minutes.

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GSK pays Isis $7 million for ISIS-GSK3Rx milestones

Tuesday, October 8, 2013 07:00 AM

GlaxoSmithKline (GSK) has added development candidate ISIS-GSK3Rx to its collaboration with Isis Pharmaceuticals. Isis earned $7 million in milestone payments associated with the advancement of this program. ISIS-GSK3Rx is an antisense drug designed to inhibit the production of an undisclosed target to treat a common viral infection. Isis will develop ISIS-GSK3Rx to phase II proof-of-concept, after which GSK has an exclusive option to in-license the program and further develop and commercialize the asset.

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Merck to continue development of Tecemotide in phase III trial

Tuesday, October 1, 2013 10:30 AM

Merck Serono, the biopharmaceutical division of Merck, has decided to continue clinical development of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide  (also known as L-BLP25 and formerly known as Stimuvax). Merck Serono, which is developing tecemotide under a license agreement with Oncothyreon, will conduct a new phase III trial called START2 for patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).

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Caris Life Sciences study reports positive results for evidence-guided tumor profiling

Tuesday, October 1, 2013 10:00 AM

Caris Life Sciences, a biosciences company focused on personalized medicine, has announced data from two studies which demonstrate the potential of evidence-guided tumor profiling to immediately improve the treatment of patients with hard-to-treat cancers, including cancers of unknown primary (CUP) and rarer and refractory cancers.

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The CenterWatch Monthly, October 2013

Tuesday, October 1, 2013 09:00 AM

New growth and decline in Asia clinical trials

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IRB market consolidating rapidly
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Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

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