DURHAM, N.C., April 29, 2013 Scioderm announced its investigational product SD-101 has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with inherited Epidermolysis Bullosa (EB). SD-101 is Scioderm’s investigational therapy that is being evaluated 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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investigational device exemption (IDE) approval
MINNEAPOLIS, April 29, 2013
CVRx, Inc., a private medical device company, received Food and Drug Administration (FDA) investigational device exemption (IDE) approval, allowing the company to proceed with its hypertension study
Barostim neo is designed to use the body’s own natural blood flow regulation system to treat hypertension.
The system works by electrically activating baroreceptors, the body’s natural blood pressure sensors that regulate cardiovascular function. When the Barostimneo is activated, signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, the heart to slow down and the kidneys to reduce fluid in the body, lowering excessive blood pressure and workload on the heart.
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People with chronic diseases like diabetes and multiple sclerosis have inflamed, leaky blood vessels, heightening their risk of heart attack and stroke. Some scientists envision using a patient’s own stem cells to regrow healthy tissue to plug the leaks and calm inflammation. A new polymer coating could help these stem cells find and adhere to inflamed endothelial tissue (J. Am. Chem. Soc., DOI: 10.1021/ja400636d).
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25 April 2013
Daiichi Sankyo Company, Limited announced today that the first patient has been enrolled in two pivotal phase 3 clinical trials of nimotuzumab (DE-766), a recombinant humanized monoclonal antibody targeting the Epidermal Growth Factor Receptor (EGFR), which is being evaluated for the treatment of patients diagnosed with lung cancer and with gastric cancer.
About Phase 3 Clinical Trials for Lung Cancer
The phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled study investigating nimotuzumab for the first-line therapy in patients with unresectable and locally advanced squamous cell lung cancer. The patients will receive either nimotuzumab in combination with concurrent chemoradiotherapy or placebo in combination with concurrent chemoradiotherapy. The primary endpoint is overall survival (OS), and the secondary endpoints are progression free survival (PFS) and safety. Approximately 420 patients are planned to be enrolled at approximately 60 clinical centers in Japan. Additional details of the trial are…
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26 April 2013
GlaxoSmithKline plc today announced the submission of a regulatory application in the European Union for the investigational once-daily medicine, umeclidinium bromide (UMEC), for patients with chronic obstructive pulmonary disease (COPD).
UMEC is an investigational bronchodilator molecule (formerly known as GSK573719), a long-acting muscarinic antagonist (LAMA), administered using the ELLIPTA™ inhaler.
A Marketing Authorisation Application (MAA) for UMEC monotherapy (55 mcg delivered dose) has been submitted to the European Medicines Agency (EMA), for a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Regulatory filings for UMEC monotherapy are imminent in the US and planned in other countries during the course of 2013.
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