Clinical Intelligence

FDA approves first generic Actos to treat type 2 diabetes

Friday, August 17, 2012 02:33 PM

The FDA has approved the first generic version of Actos (pioglitazone hydrochloride) tablets, used in conjunction with diet and exercise to improve blood glucose control in adults with type 2 diabetes. Mylan Pharmaceuticals, based in Morgantown, W.V., gained FDA approval for 15mg, 30mg and 45mg pioglitazone tablets.

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FDA approves Lucentis for diabetic macular edema

Monday, August 13, 2012 10:33 AM

The FDA has approved Genentech’s Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

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FDA approves Marqibo for rare type of leukemia

Thursday, August 9, 2012 02:56 PM

The FDA approved Talon Therapeutics’ Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL), a rapidly progressing form of blood and bone marrow cancer that is more commonly diagnosed in children than adults.

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Lightlake Therapeutics touts positive phase II results of binge eating disorder

Thursday, August 9, 2012 11:23 AM

Lightlake Therapeutics, an early stage biopharmaceutical company developing modern addiction treatments, released final data from a phase II study of its proprietary opioid antagonist naloxone nasal spray treatment for patients with binge eating disorder (BED).

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FDA approves Zaltrap for metastatic colorectal cancer

Monday, August 6, 2012 12:51 PM

The FDA has approved Sanofi-Aventis’ Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.

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Aquapharm Biodiscovery discovers novel antibiotic compound

Monday, August 6, 2012 11:01 AM

Aquapharm Biodiscovery, a Scottish marine biotechnology company, has made a discovery in the development of next-generation antibiotics.

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Array BioPharma’s ARRY-797 meets primary endpoint in osteoarthritis study

Friday, August 3, 2012 12:41 PM

Boulder, Colo.-based Array BioPharma’s phase II study of ARRY-797 met its primary endpoint osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs).

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Pfizer releases top-line data from phase III study of tofacitinib in RA

Friday, August 3, 2012 11:24 AM

Pfizer reported today top-line results from ORAL Start (A3921069), a phase III study of the investigational agent tofacitinib, a novel, oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

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Auxilium touts top-line data from Xiaflex study in Dupuytren's contracture

Monday, July 30, 2012 11:34 AM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company based in Malvern, Penn., issued positive top-line data from its phase IIIb trial evaluating Xiaflex for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. 

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FDA approves Vascepa for severe hypertriglyceridemia

Friday, July 27, 2012 10:53 AM

The FDA has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥ 500mg/dL), according to Amarin, a Bedminster, N.J.-based biopharmaceutical company focused on cardiovascular health.

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