RxTrials Institute Drug Pipeline Alert

Novo Nordisk’s Phase III study of liraglutide for patients with Type 2 diabetes yielded promising results, but the drug may face an approval delay.

Although Pfizer’s selective estrogen receptor modulator Fablyn was associated with a significant increase in all-cause mortality when compared with placebo in one arm of a Phase III trial, it still received a green light from an FDA advisory panel this week.

Celgene’s investigational small-cell lung cancer (SCLC) agent amrubicin received fast-track designation from the FDA.

A pivotal Phase III clinical study of polidocanol, conducted by BioForm Medical’s partner Chemische Fabrik Kreussler, successfully met its primary endpoint, and results have been submitted to the FDA as part of an NDA process.

The FDA has given fast-track designation to BioMS Medical for dirucotide, a drug in Phase III development for the treatment of multiple sclerosis (MS).

NeurAxon received promising data from its Phase II clinical trial of NXN-188 in patients experiencing migraine with aura.

Cytopia is beginning enrollment for its Phase Ib/II study of CYT997, its vascular-disrupting anticancer agent, in patients with an aggressive form of brain cancer known as glioblastoma multiforme (GBM).

The FDA held an end-of-Phase II meeting with Oculus Innovative Sciences for the company’s Microcyn technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers.

Regeneron Pharmaceuticals’s arcalyst reduced the incidence of gout flares in a Phase II study of gout patients initiating therapy with allopurinol to lower their uric acid levels.

Neurocrine Biosciences’ third Phase II clinical trial using elagolix in patients with endometriosis achieved positive safety and efficacy results.

Discovery Laboratories will test its proprietary, aerosolized KL-4 surfactant in a Phase IIa clinical trial for patients with cystic fibrosis (CF).

Elan and Biogen Idec have started a Phase I/II clinical trial of their multiple sclerosis drug Tysabri to treat multiple myeloma, a plasma cancer.

The first patient has been enrolled in Five Prime Therapeutics’ Phase I clinical trial of its investigational protein therapeutic, FP-1039, to treat advanced solid tumors.

Progenics Pharmaceuticals will begin a Phase I study of its prostate-specific membrane antigen (PSMA) antibody-drug conjugate (ADC).

CV Therapeutics has enrolled the first patient in a Phase I trial of CVT-3619, an oral compound for potential treatment of cardiometabolic diseases.