Clinical Intelligence

BrainStorm finds NurOwn interim phase results promising

Tuesday, January 24, 2012 10:26 AM

Data from the initial patients in BrainStorm Cell Therapeutics’ ALS (Lou Gehrig’s Disease) phase I/II human clinical trial treated with its NurOwn technology showed it did not present any significant side effects and the NurOwn treatment has so far proven to be safe, according to BrainStorm.

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First patient treated in PLC Systems' RenalGuard U.S. trial

Monday, January 23, 2012 01:57 PM

PLC Systems, focused on innovative medical device technologies, has successfully enrolled the first patient in the CIN-RG trial, its pivotal trial to study the efficacy of its RenalGuard therapy and RenalGuard system in the prevention of Contrast-Induced Nephropathy (CIN).

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FDA committee fails to recommend gel to reduce preterm birth

Monday, January 23, 2012 01:55 PM

The FDA’s advisory committee for Reproductive Health Drugs did not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy, confirmed Columbia Laboratories and Watson Pharmaceuticals.

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Alexza extends Adasuve PDUFA goal date by three months

Monday, January 23, 2012 12:56 PM

The FDA will require additional time to complete its review of the New Drug Application (NDA) for Adasuve (Staccato loxapine), according to Alexza Pharmaceuticals.

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UH Case Medical Center testing new therapy for gynecologic cancer

Sunday, January 22, 2012 01:42 PM

Patients with gynecologic cancer have new hope in a novel technology now offered at the Seidman Cancer Center at University Hospitals (UH) Case Medical Center. A team of cancer specialists, led by Robert DeBernardo, M.D., is among the first in the nation to launch a dedicated program using Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to treat ovarian, endometrial and select other cancers.

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Soligenix anthrax vaccine shows robust stability

Sunday, January 22, 2012 11:17 AM

Soligenix, a development-stage biopharmaceutical company, shared results from long-term stability studies of its proprietary DNI (dominant negative inhibitor) anthrax rPA (recombinant protective antigen) subunit protein vaccine, known as SGX204.

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Ferrer begins phase III trial of Ozenoxacin for skin conditions

Saturday, January 21, 2012 01:12 PM

Ferrer, a privately-held Spanish pharmaceutical company, has received approval to initiate phase III clinical trials of ozenoxacin formulated as a topical treatment for infectious dermatological conditions. The first patients are expected to enter the trials in February 2012 and the studies are scheduled to conclude in the first quarter of 2013.

The randomized, placebo-controlled, parallel, double-blinded, superiority clinical study will compare ozenoxacin 1% cream versus a placebo. The trial will be conducted in about 465 patients up to two years old with a clinical diagnosis of non-bullous or bullous impetigo. Fifty centers will be participating in the study in the U.S., South Africa, Germany, Romania, India and Ukraine.

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FDA approves Viread for children with HIV-I

Friday, January 20, 2012 03:48 PM

The FDA has approved Gilead Sciences’ Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-I infection in pediatric patients ages 2 to 12.

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Twice monthly injections could replace daily growth hormone regimen

Friday, January 20, 2012 03:14 PM

Prolor Biotech has released positive top-line results from a post-phase II clinical study of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. Data shows that two injections of hGH-CTP per month have the potential to replace 30 consecutive daily injections of currently marketed human growth hormone.

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Hep C suppressed by combination of oral drugs

Friday, January 20, 2012 03:10 PM

A new combination of investigational drugs successfully suppressed hepatitis C genotype I infection in a high percent of patients who had not responded to previous treatment in a study led by a University of Michigan hepatologist.

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