Positive review of the European Medicines Agency in the approval process of Biofrontera's BF-200 ALA

31-Jan-2011 - Biofrontera has received a positive interim report of the responsible committee of the European Medicines Agency (EMA) in the ongoing centralized approval process of BF-200 ALA for the treatment of actinic keratosis.The "Committee for Medicinal Products for Human Use (CHMP)" provides applicants ...

Bionovo to Advance Menerba to Phase 3 Clinical Testing in Europe

02-Aug-2010 - Bionovo, Inc. announced that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European ...

Aeterna Zentaris Receives Positive Scientific Advice for its Phase 3 Trial with Perifosine in Colorectal Cancer

01-Jul-2010 - Aeterna Zentaris Inc. announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer. The ...

Hybrigenics receives positive answers from EMEA

EMEA gives official scientific advice on clinical Phase IIb efficacy study of inecalcitol in hormone-refractory prostate cancer

04-Feb-2010 - Hybrigenics announced that it has received the official scientific advice from the European Medicines Agency (EMEA) on Hybrigenics' clinical development plan for inecalcitol in hormone-refractory prostate cancer patients. EMEA's recommendations back the protocol proposed by Hybrigenics and will ...

NicOx submits naproxcinod MAA to the EMEA

23-Dec-2009 - NicOx S.A. announced that a Marketing Authorization Application (MAA) for naproxcinod has been submitted to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). This follows the ...

Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation

First New Anti-Arrhythmic Drug to be Approved in the European Union in the Last 10 Years

02-Dec-2009 - Sanofi-aventis announced that the European Commission has granted marketing authorization for Multaq(R) (dronedarone - 400mg Tablets) in all 27 European member states. This approval follows the European Commission positive opinion issued onSeptember 25, 2009by the Committee for Medicinal Products ...

Novartis A(H1N1) Pandemic Influenza vaccine Focetria receives positive opinion from CHMP

29-Sep-2009 - Novartis announced that Focetria®, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The positive opinion clears the way for European Union approval in all ...

UCB receives CHMP positive opinion on Keppra for infants and young children with partial-onset epilepsy

European marketing approval recommended for Keppra (levetiracetam) as adjunctive treatment of partial-onset seizures in infants and young children aged one month to under four years

27-Jul-2009 - UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grant marketing authorisation for Keppra® as adjunctive treatment of partial-onset seizures in infants and ...

Sanofi-aventis welcomes the European Medicines Agency’s statement on Lantus safety

27-Jul-2009 - Sanofi-aventis announced that following the review of the available evidence on Lantus® (insulin glargine [rDNA] injection), the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed the product’s safety and concluded that changes to the prescribing advice ...

SYGNIS Receives Orphan Drug Designation from the European Commission for AX200 in the treatment of Spinal Cord Injury

Second indication for AX200 given Orphan Drug status

18-Nov-2008 - SYGNIS Pharma AG announced that it has received Orphan Drug designation from the European Commission for AX200 in the treatment of Spinal Cord Injury (SCI). This follows the positive recommendation that SYGNIS received from the EMEA in September. A spinal cord injury (SCI) is damage or trauma ...