Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Xeljanz (tofacitnib citrate) for the treatment of adults with moderate to severe active rheumatoid arthritis

Addex Therapeutics SA, of Geneva, reported preclinical data showing that its mGlu5 negative allosteric modulator oral small molecule, dipraglurant, dose-dependently prevented the abnormal excitatory effect observed on brain slices of transgenic primary generalized torsion dystonia 1 (DYT1) mice overexpressing the human mutant TOR1A gene by decreasing the paradoxical neuronal activity induced by the dopamine D2 receptor agonist quinpirole. DYT1 is a common and severe genetic form of dystonia

Gentium SpA, of Villa Guardia, Italy, said it requested a re-examination of the negative opinion adopted by the European Committee for Medicinal Products for Human Use (CHMP) March 22, regarding the marketing authorization application (MAA) submitted for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

The withdrawal is based on a request by the European Committee for Medicinal Products for Human Use/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study

The withdrawal follows major objections identified as part of the preliminary Committee for Advanced Therapies and Committee for Medicinal Products for Human Use reviews

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...The goal is to modulate the half-life of the therapy to increase efficacy of treatment...The company intends to start clinical trials in the third quarter

Vivus Inc., of Mountain View, Calif., said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed its Oct. 18, 2012, decision to decline the Marketing Authorization Application (MAA) for Qsiva (phentermine/topiramate ER) for the treatment of obesity in the European Union

Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima, the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b

Gentium SpA, of Villa Guardia, Italy, made an oral presentation for the European Medicines Agency's Committee for Medicinal Products for Human Use supporting its marketing authorization application for Defibrotide in hepatic veno-occlusive disease in adults and children receiving hematopoietic stem cell transplantation therapy

The EMA's Committee for Medicinal Products for Human Use granted GSK's request for accelerated assessment of the application

The EMA's Committee for Medicinal Products for Human Use granted GSK's request for accelerated assessment of the application

Gentium SpA, of Villa Guardia, Italy, said it was informed that its marketing authorization application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy will be on the agenda for discussion at the European Committee for Medicinal Products for Human Use meetings set for Feb. 18-21

Pfizer Inc., of New York, said the Committee for Medicinal Products for Human Use of the European Medicines Agency offered a positive opinion on the conditional marketing authorization of bosutinib in the European Union (EU) in chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia patients previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment

Gentium SpA, of Villa Guardia, Italy, said it was informed that its marketing authorization application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy will be on the agenda for discussion at the European Committee for Medicinal Products for Human Use meetings set for Feb. 18-21

Intercell AG, of Vienna, Austria, said the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a marketing authorization application by for Ixiaro, a vaccine against Japanese encephalitis

Intercell AG, of Vienna, Austria, said the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a marketing authorization application by for Ixiaro, a vaccine against Japanese encephalitis

Gentium SpA, of Villa Guardia, Italy, said it submitted responses to the second list of outstanding issues to the European Committee for Medicinal Products for Human Use in connection with the company's marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

Genzyme Corp., of Cambridge Mass., a unit of Sanofi SA, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with homozygous familial hypercholesterolemia

Vanda Pharmaceuticals Inc., of Rockville, Md., said the European Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients