Theorem Clinical Research

Clinical Intelligence

BioDelivery hits mid-enrollment in phase III diabetic neuropathy trial

Thursday, May 8, 2014 01:55 PM

BioDelivery Sciences International, a specialty pharmaceutical company, has randomized more than half of the planned number of patients required for its ongoing initial phase III study of Clonidine Topical Gel, BDSI's proposed treatment for painful diabetic neuropathy (PDN).

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FDA approves EPANOVA for severe hypertriglyceridemia

Wednesday, May 7, 2014 02:43 PM

AstraZeneca has announced the FDA approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

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Upsher-Smith announces positive data for epilepsy drug USL261

Friday, May 2, 2014 12:23 PM

Upsher-Smith Laboratories has announced positive phase I data for USL261 (investigational intranasal midazolam) in patients with epilepsy. Results demonstrated that USL261 at a single dose of up to 7.5mg was rapidly absorbed and exhibited a short half-life. Additionally, USL261 generally was well-tolerated in patients with epilepsy and demonstrated a rapid onset of pharmacodynamic effects with return to baseline function by four hours post dose.

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The CenterWatch Monthly, May 2014

Thursday, May 1, 2014 08:55 AM

Patient-centric strategies taking flight

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Edmond Pharma’s Erdosteine receives Orphan Drug Status from FDA

Wednesday, April 30, 2014 03:29 PM

The FDA has granted Orphan Drug Status to Erdosteine, a molecule discovered and developed by Italian pharmaceutical company Edmond Pharma. The Orphan Drug Status refers to the new indication for the treatment of bronchiectasis, a rare disease for which no drug therapies currently are approved in the U.S.

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FDA approves Zykadia for late-stage lung cancer

Wednesday, April 30, 2014 03:01 PM

The FDA has granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

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FDA approves Sylvant for rare Castleman’s disease

Thursday, April 24, 2014 11:39 AM

The FDA has approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).

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FDA approves Cyramza for stomach cancer

Wednesday, April 23, 2014 02:23 PM

The FDA has approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

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GSK, Genmab receive FDA approval for Arzerra (ofatumumab) for CLL

Monday, April 21, 2014 09:27 AM

GlaxoSmithKline and Genmab have announced that the FDA has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

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First patient enrolled in Boston Scientific’s new clinical registry

Friday, April 18, 2014 10:43 AM

Boston Scientific has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise Deep Brain Stimulation (DBS) System in patients with Parkinson's disease (PD).

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