Clinical Intelligence

FDA backs Tarix Orphan’s potential DMD treatment

Tuesday, October 6, 2015

Cambridge, Mass.-based Tarix Orphan, a privately held biopharmaceutical company focused on the treatment of rare neuromuscular disorders and connective tissue diseases, has received the FDA’s Fast Track Designation for TXA127 (angiotensin 1-7) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.

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FDA approves cancer drug Keytruda

Monday, October 5, 2015

The FDA has granted Accelerated Approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

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FDA accepts Sandoz submission for proposed biosimilar

Monday, October 5, 2015

The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.

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Neothetics initiates body contouring study

Thursday, October 1, 2015

Neothetics, a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, has initiated the safety study, LIPO-202-CL-21, of LIPO-202, the first noninvasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that Neothetics expects to submit to the FDA as part of the company’s NDA package for LIPO-202, which the company anticipates filing in the second half of 2016.

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NIH launches substance use and adolescent brain development study

Monday, September 28, 2015

The NIH has awarded 13 grants to research institutions around the country as part of a study about the effects of adolescent substance use on the developing brain. The Adolescent Brain Cognitive Development (ABCD) Study will follow about 10,000 children beginning at ages 9 and 10, before they initiate drug use, through the period of highest risk for substance use and other mental health disorders. Scientists will track exposure to substances (including nicotine, alcohol and marijuana), academic achievement, cognitive skills, mental health and brain structure and function using advanced research methods.

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EMA fast-tracks antidote to Pradaxa

Monday, September 28, 2015

The EMA has recommended granting a marketing authorization, following Accelerated Assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required. Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs.

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OncoGenex’s phase II Rainier study shows poor results

Thursday, September 24, 2015

OncoGenex Pharmaceuticals has reported initial results from the phase II Rainier study evaluating apatorsen in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) and gemcitabine compared to Abraxane and gemcitabine alone in patients with untreated metastatic pancreatic cancer. The addition of apatorsen to Abraxane and gemcitabine did not demonstrate a survival benefit compared to Abraxane and gemcitabine alone. The study was sponsored and conducted by Sarah Cannon Research Institute (SCRI).

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