Clinical Intelligence

UCB begins C-EARLY study for rheumatoid arthiritis

Monday, February 27, 2012 03:59 AM

Brussels-based UCB has initiated C-EARLY, a phase III study to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in combination with methotrexate (MTX) for inducing and sustaining clinical response in adults with rheumatoid arthritis (RA) not previously treated with disease-modifying antirheumatic drugs (DMARDs).

More... »

FDA approves first-ever med for Cushing’s syndrome

Friday, February 24, 2012 11:14 AM

The FDA has approved Korlym (mifepristone) 300mg tablets as a once-daily oral medicine to control hyperglycemia secondary to hypercorisolism in adults with endogenous Cushing’s syndrome, according to Corcept Therapeutics.

More... »

Positive phase IIb results in Threshold pancreatic cancer trial

Friday, February 24, 2012 11:13 AM

Threshold Pharmaceuticals’ TH-302 combination phase IIb study for pancreatic cancer has reached its primary endpoint with a 63% improvement in progression free survival and a safety profile consistent with previous studies.

More... »

ALS Therapy to launch phase II trial of TDI 132

Wednesday, February 15, 2012 04:03 PM

The ALS Therapy Development Institute, a nonprofit biotech, will be launching a phase II clinical trial on TDI 132 (fingolimod)—currently used as treatment for multiple sclerosis—as a potential treatment for ALS (Lou Gehrig's disease). 

More... »

FDA approves BioSante’s Bio-T-Gel

Wednesday, February 15, 2012 03:59 PM

The FDA has approved Bio-T-Gel for the treatment of male hypogonadism (low testosterone levels), according to BioSante Pharmaceuticals.

More... »

Phase II trial of Letermovir meets primary efficacy endpoints

Wednesday, February 15, 2012 03:54 PM

AiCuris, a clinical-stage biopharmaceutical company developing drugs against severe infectious diseases, released positive results from its placebo-controlled and dose-ranging phase II trial with Letermovir (AIC246).

More... »

Santarus initiates phase IIIb study with Uceris in ulcerative colitis

Tuesday, February 14, 2012 07:40 AM

Santarus, a specialty pharmaceutical company, has begun patient enrollment in phase IIIb clinical study with the investigational drug Uceris (budesonide) tablets 9mg in combination with current oral aminosalicylate (5-ASA) therapy for patients with active ulcerative colitis.

More... »

CESAR and Saladax collaborate on a study of optimized 5-FU dosing in colorectal cancer patients

Tuesday, February 14, 2012 07:33 AM

Saladax Biomedical and the Central European Society for Anticancer Drug Research (CESAR) will be collaborating in a single-arm study of metastatic colorectal cancer patients treated with the chemotherapy drug 5-fluorouracil (5-FU).

More... »

EMA objects to Alexza’s Adasuve MAA

Tuesday, February 14, 2012 07:18 AM

Alexza Pharmaceuticals has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve, which seeks approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder.

More... »

University of Minnesota licenses cyanide antidote to Vytacera

Monday, February 13, 2012 03:46 PM

The University of Minnesota has licensed Sulfanegen, an antidote for cyanide poisoning, to California start-up Vytacera Pharma.

More... »