Gentium SpA, of Villa Guardia, Italy, filed the documentation requesting a re-examination of the negative opinion given by the European Committee for Medicinal Products for Human Use (CHMP), regarding the marketing authorization for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy
The Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on granting marketing authorization to Bavarian Nordic A/S, of Kvistgard, Denmark, for Imvanex, a smallpox vaccination for the general adult population, including those with immunodeficiencies...Celgene International Sarl, of Boudry, Switzerland, a subsidiary of Celgene Corp., said the European Medicines Agency's (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a
Gentium SpA, of Villa Guardia, Italy, filed the documentation requesting a re-examination of the negative opinion given by the European Committee for Medicinal Products for Human Use (CHMP), regarding the marketing authorization for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy
Teva Pharmaceutical Industries Ltd., of Jerusalem, said the Committee for Medicinal Products for Human Use (CHMP) recommended that a marketing authorization may be issued in the European Union for Lonquex (XM22 lipegfilgrastim) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes
Aegerion Pharmaceuticals Inc., of Cambridge, Mass., said the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion with a unanimous vote recommending a marketing authorization for Lojuxta (lomitapide) hard capsules...The Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on granting marketing authorization to Bavarian Nordic A/S, of Kvistgard, Denmark, for Imvanex, a smallpox vaccination for the general
Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...Curis Inc., of Lexington, Mass., said the European Committee for Medicinal Products for Human Use
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
BioWorld International | Wednesday, April 24, 2013
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
Mast Therapeutics Inc., of San Diego, said the European Commission designated MST-188 (purified poloxamer 188) as an orphan medicinal product for the treatment of sickle cell disease
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
BioWorld International | Wednesday, February 27, 2013
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 decision follows a positive review by the Committee for Medicinal Products for Human Use in April