Optimer Pharmaceuticals Inc., of San Diego, submitted a marketing authorization application for fidaxomicin, a macrocycle, which inhibits the bacterial enzyme RNA polymerase, to the European Medicines Agency under the European Union's centralized procedure as a treatment for Clostridium difficile infection
QRxPharma Ltd., of Bedminster, N.J., said based on positive outcomes of its European scientific advice meetings in Germany and the UK in May on the development and registration of MoxDuo IR, an immediate-release dual-opioid pain therapy, the firm intends to select Germany as the lead agency for European marketing authorization application review, with plans to submit the application in 2011
The firm is preparing to submit a marketing authorization application in the European Union, and plans to initiate a Phase III trial of pixantrone in patients with relapsed or refractory aggressive NHL in the U.S. Both are planned for this year...Novalar Pharmaceuticals Inc., of San Diego, and Sanofi-Aventis Deutschland GmbH, a unit of Paris-based Sanofi-Aventis SA, said regulatory agencies in the UK, Germany, Italy, France and Spain accepted for review the marketing authorization application for
Alimera Sciences Inc., of Atlanta, and PSivida Corp., of Watertown, Mass., submitted a marketing authorization application in the UK for Iluvien (fluocinolone acetonide intravitreal insert) for diabetic macular edema
Cell Therapeutics Inc., of Seattle, submitted an expanded pediatric investigation plan to the European Medicines Agency in submitting a marketing authorization application for pixantrone in relapsed or refractory, aggressive non-Hodgkin's lymphoma...Dyax Corp., of Cambridge, Mass., said the European Medicines Agency has completed its validation process for the marketing authorization application for DX-88 (ecallantide) and begun its formal scientific review
Ltd., of Osaka, Japan, said the European Medicines Agency has validated AMAG's submission of its marketing authorization application for Feraheme (ferumoxytol) as a treatment for iron deficiency anemia in chronic kidney disease patients
Human Genome Sciences Inc., of Rockville, Md., said its partner, GlaxoSmithKline plc, of London, submitted a marketing authorization application to the European Medicines Agency for the approval of Benlysta (belimumab) as a treatment of systemic lupus erythematosus based on the results of two pivotal Phase III trials in autoantibody-positive patients with SLE
Cell Therapeutics Inc., of Seattle, met with and received encouraging feedback from the rapporteurs and the European Medicines Agency's medical reviewers regarding a proposed filing of a marketing authorization application for pixantrone in the European Union to treat relapsed/refractory aggressive non-Hodgkin's lymphoma...The company expects to submit the marketing authorization application in September
Eisai Europe Ltd., of London, has submitted a marketing authorization application to the European Medicines Agency for approval of eribulin mesylate, also known as E7389, for the treatment of locally advanced or metastatic breast cancer
ViroPharma Inc., of Exton, Pa., said that the European Medicines Agency has accepted the filing of its marketing authorization application for Cinryze for acute treatment and prophylaxis against hereditary angioedema (HAE), which was submitted through the centralized procedure
InterMune Inc., of Brisbane, Calif., said its marketing authorization application submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis in adults was validated by the European Medicines Agency
Basilea Pharmaceutica AG, of Basel, Switzerland, said that Johnson & Johnson unit Janssen-Cilag International NV, of Beerse, Belgium, submitted a request for re-examination of the negative opinion by the European Committee for Medicinal Products for Human Use (CHMP) on the marketing authorization application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI
BioWorld International | Wednesday, March 17, 2010
Basilea Pharmaceutica AG, of Basel, Switzerland, said that Johnson & Johnson unit Janssen-Cilag International NV, of Beerse, Belgium, submitted a request for re-examination of the negative opinion by the European Committee for Medicinal Products for Human Use (CHMP) on the marketing authorization application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI
The parties will collaborate to submit the marketing authorization application in several European countries with an anticipated approval in Germany by 2011
Once that plan is approved, CTI will submit a marketing authorization application for pixantrone in the European Union later this year