Clinical Intelligence

FDA approves Shire’s FIRAZYR

Thursday, August 25, 2011 11:33 AM

The FDA has granted marketing approval for Shire’s FIRAZYR (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

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Life Extension begins recruitment for Alzheimer’s trial

Thursday, August 25, 2011 11:06 AM

Life Extension is actively recruiting participants for a free clinical trial to study the effects of natural supplements and an innovative medical therapy on Alzheimer's disease. Mild to moderate Alzheimer's patients (as diagnosed by their physician) are needed for a 17- to 18-week study. This study requires weekly visits to the office of the study's principal investigator located in the Fort Lauderdale area. Participants will receive blood tests, medical evaluations, blood pressure checks, and study medication and supplements at no cost.

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Bayer’s Radium-223 granted Fast Track Designation

Tuesday, August 23, 2011 12:58 PM

Bayer HealthCare Pharmaceuticals’ investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with bone metastases.

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Delcath’s phase II liver cancer trial shows promising results

Monday, August 22, 2011 12:45 PM

Delcath Systems has reported encouraging top-line results from the hepatobiliary cohort of the phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer.

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FDA accepts Alexza’s Adasuve NDA

Friday, August 19, 2011 10:33 AM

The FDA has accepted Alexza Pharmaceuticals’ ADASUVE New Drug Application (NDA) as a complete, class II response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.  Alexza resubmitted the ADASUVE NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.

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Zogenix’s phase III Zohydro trial meets primary endpoints

Thursday, August 18, 2011 11:07 AM

Zogenix has reported positive top-line results from its pivotal phase III efficacy study (Study 801) of Zohydro (hydrocodone bitartrate) extended-release capsules. Zohydro is being evaluated for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy for an extended period of time. If approved, Zohydro could be the first extended-release hydrocodone treatment available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time.

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FDA approves first gene-targeted drug for Melanoma

Wednesday, August 17, 2011 12:05 PM

The FDA has approved Zelboraf, known as vemurafenib or PLX4032 during testing, well ahead of the approval deadline.  Zelboraf is the first drug to treat advanced melanoma by targeting a specific gene mutation.

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Lexicon’s phase II LX1032 trial shows positive results

Tuesday, August 16, 2011 02:03 PM

Lexicon Pharmaceuticals has reported positive, top-line proof-of-concept data from its recently completed phase II study in carcinoid syndrome with LX1032, telotristat etiprate. Carcinoid syndrome is a chronic condition caused by neuroendocrine tumors that usually originate from the gastrointestinal tract. It is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease, and death. Symptoms of carcinoid syndrome have been linked to excess production of serotonin by metastatic tumor cells. Telotristat etiprate is designed to reduce serotonin production.

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Ultragenyx initiates phase I UX001 trial

Tuesday, August 16, 2011 01:52 PM

Ultragenyx Pharmaceutical, a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, has begun the dosing of the first patient in a phase I study of UX001 for hereditary inclusion body myopathy (HIBM). UX001 is an extended release formulation of sialic acid intended as a substrate replacement therapy for HIBM, a severe, progressive, genetic neuromuscular disease caused by sialic acid deficiency. UX001 is the first program from the company's pipeline to enter the clinic since its founding in 2010.

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Marshall Edwards’ lead candidate ME-143 receives FDA approval

Tuesday, August 16, 2011 10:16 AM

Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has reported that its Investigational New Drug (IND) application for ME-143 (formerly NV-143),  the company's lead NADH oxidase inhibitor, has been approved by the FDA. The company plans to initiate a phase I clinical trial of intravenous ME-143.

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