Clinical Intelligence

Palatin Technologies reports successful completion of device bioequivalence trial

Tuesday, October 29, 2013 09:00 AM

Palatin Technologies has announced the successful completion of a clinical trial designed to demonstrate equivalence of subcutaneously administered bremelanotide via autoinjector compared to pre-filled syringe administration. Bioequivalence was achieved in this clinical trial. Palatin used pre-filled syringes in its phase II clinical trials, but will use the single-dose disposable autoinjector in its planned phase III clinical trials and for commercialization.

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WIRB Copernicus Group

FDA approves Actelion's Opsumit for pulmonary arterial hypertension

Monday, October 21, 2013 12:53 PM

The FDA has approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.

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CRF Health eCOA webinar series

Evotec receives $5.4 million milestone payment from Boehringer Ingelheim

Monday, October 21, 2013 11:52 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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New brain technology for ALS patients will launch clinical trials in Philadelphia

Monday, October 21, 2013 08:00 AM

A new technology that will enable patients suffering from ALS—commonly known as Lou Gehrig's disease—to communicate via brain monitor, will hold its first clinical trials in Philadelphia. Congressman Chaka Fattah (PA-02) was on hand for the announcement, made Tuesday at the BrainTech Israel conference in Tel Aviv.

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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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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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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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