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Butrans Transdermal System CIII receives new dosage strength approval

Wednesday, July 23, 2014 08:00 AM

Purdue Pharma has announced that the FDA approved a new 7.5mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans now will be available: 5mcg/hour, 7.5mcg/hour, 10mcg/hour, 15mcg/hour and 20mcg/hour. The Butrans Transdermal System also is approved to allow the use of two patches to facilitate dose adjustments during titration. The total dose from both patches should not exceed 20mcg/hour. Purdue expects to launch Butrans 7.5mcg/hour commercially in the U.S. in October 2014.

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Ruthigen treats first human subjects in clinical trial for RUT58-60

Tuesday, July 22, 2014 08:00 AM

Ruthigen, a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, has treated the first human subjects with its drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August.

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Dipexium Pharmaceuticals initiates phase III trial

Monday, July 21, 2014 08:00 AM

Dipexium Pharmaceuticals has initiated patient enrollment in the first of two pivotal phase III clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex (pexiganan cream 0.8%), the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI.

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FDA approves Ruconest for hereditary angioedema attacks

Thursday, July 17, 2014 10:49 AM

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

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FDA approves IDE for VENITI VICI Venous Stent System

Monday, July 14, 2014 01:33 PM

Veniti, a provider of innovative technology for the treatment of venous disease, announced has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous Stent System was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.

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Health Canada approves APTIOM (eslicarbazepine acetate) for epilepsy

Monday, July 14, 2014 01:13 PM

Sunovion Pharmaceuticals Canada has announced that Health Canada approved APTIOM (eslicarbazepine acetate) for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy. APTIOM is not indicated for use in patients under 18 years of age.

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CardioCell begins phase IIa trial using itMSC therapy for chronic heart failure

Thursday, July 10, 2014 02:37 PM

CardioCell, a Stemedica Cell Technologies subsidiary that creates allogeneic stem-cell therapies for cardiovascular indications, has started its phase IIa clinical trial for chronic heart failure (HF) patients with non-ischemic cardiomyopathy.

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Amgen receives FDA Breakthrough Therapy Designation for Blinatumomab in ALL

Wednesday, July 2, 2014 11:04 AM

The FDA has granted Breakthrough Therapy Designation to Amgen’s investigational bispecific T cell engager (BiTE) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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The CenterWatch Monthly, July 2014

Tuesday, July 1, 2014 07:00 AM

IRB market consolidating rapidly

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FDA approves Afrezza to treat diabetes

Monday, June 30, 2014 02:29 PM

The FDA has approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal.

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