Clinical Intelligence

OncoGenex initiates trial in advanced squamous cell lung cancer

Thursday, May 30, 2013 01:21 PM

OncoGenex Pharmaceuticals plans initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label phase II trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer.

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WIRB Copernicus Group

Targacept initiates phase IIb study of TC-5214

Thursday, May 30, 2013 01:14 PM

Targacept, a clinical-stage biopharmaceutical company developing novel neuronal nicotinic receptors (NNR) therapeutics, plans the initiation of a phase IIb clinical study of TC-5214 as a treatment for overactive bladder (OAB). TC-5214 acts potently on alpha3beta4 and other NNRs located in or around the bladder  believed to play a key role in bladder contraction and signaling of the urge to urinate.

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CRF Health eCOA webinar series

FDA grants Breakthrough Therapy status to asfotase alfa for HPP

Wednesday, May 29, 2013 12:33 PM

The FDA has granted Breakthrough Therapy designation to asfotase alfa for the treatment of patients with hypophosphatasia (HPP), according to Alexion Pharma International, a global pharmaceutical company based in Cheshire, Conn.

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FDA approves Bayer’s Xofigo for advanced prostate cancer

Thursday, May 23, 2013 08:00 AM

The FDA has approved Bayer Pharmaceuticals’ Xofigo (radium Ra 223 dichloride) to treat males with symptomatic late-stage metastatic castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

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Janssen Biotech’s Simponi receives FDA approval for ulcerative colitis

Monday, May 20, 2013 08:00 AM

The FDA has approved Janssen Biotech’s Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.

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FDA approves GSK’s Breo Ellipta to treat COPD

Friday, May 17, 2013 01:25 PM

The FDA has approved GlaxoSmithKline and Theravance’s Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 

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Soligenix initiates phase 1 study of SGX203 for pediatric Crohn's disease

Thursday, May 16, 2013 08:00 AM

Soligenix, a clinical stage biopharmaceutical company focused on inflammatory diseases and biodefense countermeasures, has initiated the first clinical study for development of SGX203 (oral beclomethasone 17, 21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. The program has previously received Fast Track and Orphan Drug designations from the FDA for oral BDP as a treatment for pediatric Crohn's disease.

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FDA grants Breakthrough Therapy Scioderm's SD-101 for epidermolysis bullosa

Monday, May 6, 2013 12:29 PM

Scioderm’s investigational product SD-101 has received Breakthrough Therapy designation from the FDA for the treatment of inherited epidermolysis bullosa (EB). 

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Raptor Pharma's Procysbi receives FDA approval for nephropathic cystinosis

Friday, May 3, 2013 02:02 PM

The FDA has approved Raptor Pharmaceutical’s Procysbi(cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children six years and older.

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FDA grants Genmab’s daratumumab Breakthrough Therapy Designation

Friday, May 3, 2013 11:55 AM

The FDA has granted Breakthrough Therapy Designation for Genmab’s daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and IMiD. 

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