Clinical Intelligence

Affinium doses first patient with oral AFN-1252 for skin infections

Wednesday, February 1, 2012 04:04 PM

Affinium Pharmaceuticals has dosed its first patient in a multi-center phase II clinical trial evaluating oral AFN-1252 in acute bacterial skin and skin structure infections. The phase II trial is the first human efficacy study conducted with this new class of antibiotic and follows the recently completed phase I trials, which demonstrated excellent safety, tolerability and pharmacokinetics of AFN-1252 in single and multiple ascending oral dosages.

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IDRI supports first phase I human hookworm vaccine trial

Wednesday, February 1, 2012 04:01 PM

The Infectious Disease Research Institute (IDRI) has joined Sabin Vaccine Institute's venture to develop a human hookworm vaccine—which affects 600 million people worldwide—by contributing a proprietary adjuvant as a component. The phase I trial, which began last week in Brazil, aims to reduce the global burden of human hookworm by providing effective long-term protection for those who are most at risk.

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FDA approves first surgical treatment to remove cellulite

Wednesday, February 1, 2012 03:30 PM

The FDA has approved Cellulaze, a single-treatment laser that affects the physiological structure of cellulite. Cellulaze, which previously gained approval in the U.K., was developed by Cynosure, a global aesthetic laser manufacturer and creator of the SmartLipo laser.

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Pinpoint Genomics publishes Dx Lung assay data

Tuesday, January 31, 2012 09:38 AM

Pinpoint Genomics has published key data relating to its Pinpoint Dx Lung assay in the journal The Lancet, and has made the assay available to clinicians and patients exclusively through the company's laboratory in Mountain View, Calif.

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VGX-100 identified as potential therapy for improving corneal graft survival

Monday, January 30, 2012 02:40 PM

Circadian Technologies has published data in Investigative Ophthalmology & Visual Science (IOVS) showing that VEGF-C expression is markedly up-regulated in corneal graft rejection. The data also showed that VEGF-C blockade, through administration of Circadian's lead development candidate VGX-100, a human antibody against VEGF-C, significantly improved corneal graft survival in an animal model. The data indicates a new therapeutic opportunity for VGX-100 to improve corneal graft survival.

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Juventas reports data from phase I heart failure trial

Monday, January 30, 2012 02:37 PM

Cleveland, Ohio-based Juventas Therapeutics, developing novel regenerative therapies for treating cardiovascular disease, has released the 12-month results from its phase I heart failure study of JVS-100.

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FDA approves once-weekly treatment for type 2 diabetes

Monday, January 30, 2012 02:35 PM

The FDA has approved Bydureon (extended-release exenatide), the first once-weekly treatment for type 2 diabetes, developed by Amylin Pharmaceuticals and Alkermes.

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FDA approves Inlyta to treat advanced kidney cancer

Saturday, January 28, 2012 08:27 AM

The FDA has approved Pfizer’s Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

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Tasimelteon could reset body’s clock in sleep-wake disorder

Friday, January 27, 2012 02:17 PM

Vanda Pharmaceuticals’ compound tasimelteon has shown for the first time to reset the body clock and to align it to a constant 24-hour day in patients suffering from Non-24-Hour Sleep-Wake Disorder. Tasimelteon is a circadian regulator in development for the treatment of the sleep-wake disorder in completely blind individuals with no light perception.

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Galena initiates enrollment in NeuVax phase III trial

Friday, January 27, 2012 02:15 PM

Galena Biopharma, a biotechnology company focused on developing targeted oncology treatments, has initiated its phase III PRESENT trial for NeuVax (E75 peptide plus GM-CSF) vaccine in HER2 1+ and 2+ breast cancer patients (often referred to as HER2 negative) in the adjuvant setting to prevent recurrence.

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