European Medicines Agency (EMA)
7 Westferry Circus
506 articles with European Medicines Agency (EMA)
Fexinidazole would be first all-oral treatment* under investigation for both first and second stages of sleeping sickness.
European Medicines Agency Issues Orphan Drug Designation Positive Opinion for Omeros’ OMS721 in the Treatment of IgA Nephropathy
Omeros Corporation announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion on Omeros’ application for orphan drug designation of OMS721 in the treatment of primary Immunoglobulin A nephropathy (IgAN).
Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August 2017.
ChemoCentryx: Avacopan Conditional Marketing Authorization Application Accepted for Regulatory Review by European Medicines Agency
Under the terms of its kidney health alliance with VFMCRP, ChemoCentryx will receive a milestone payment triggered by this validation of the avacopan CMA application by the EMA.
GW Pharmaceuticals Submits Marketing Authorisation Application in Europe for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome and Dravet Syndrome
In October 2017, GW completed the submission of its rolling Epidiolex NDA to the FDA, also for seizures associated with LGS and Dravet syndrome.
Rucaparib MAA for the Ovarian Cancer Treatment Indication Referred by CHMP to Scientific Advisory Group on Oncology for Review Expected in February 2018
The exact date for the SAG meeting has not yet been set but we expect it to take place in early February 2018.
The CHMP’s opinion will now be sent to the European Commission (EC) for final review.
Alnylam and Sanofi Submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis
Alnylam announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for patisiran.
ProQR Receives Orphan Drug Designation From EMA for Drug Candidate QR-313 for Dystrophic Epidermolysis Bullosa
DEB is a rare genetic disease that can lead to severe blistering of the skin resulting in high treatment burden and poor quality of life for patients.
EMA Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients With Advanced Renal Cell Carcinoma
The application is based on results from the Phase 3 CheckMate -214 study.
11/21/2017Pharma and biotech stakeholders applauded the vote as Amsterdam achieved the hightest rate of acceptance of the EMA staff for relocatation, according to a survey.
European Medicines Agency Grants Alnylam Accelerated Assessment of Patisiran for Patients with Hereditary ATTR (hATTR) Amyloidosis
Alnylam intends to file a marketing authorization application (MAA) in the European Union (EU) at year-end 2017.
EMA Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (Nivolumab) for Treatment of Patients With Resected High-Risk Advanced Melanoma
The type II variation submitted is based on data from CheckMate -238, an ongoing phase 3, randomized double-blind study of Opdivo 3 mg/kg versus Yervoy (ipilimumab) 10 mg/kg in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma, in which Opdivo met its primary endpoint of recurrence-free survival.
Wilson Therapeutics Reaches Agreement With The FDA And EMA To Initiate Pivotal Phase 3 FOCuS study With WTX101 in Wilson Disease
Wilson Therapeutics (publ) today announced that the discussions with the FDA and the EMA, regarding the study protocol for the single pivotal Phase 3 FOCuS trial for WTX101 in Wilson Disease, have been concluded successfully.
Ignyta Receives European Medicines Agency Prime Designation for Entrectinib in NTRK Fusion-Positive Solid Tumors
Ignyta, Inc. today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation for entrectinib in the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy.
Rexahn Pharmaceuticals, Inc. Receives Positive Opinion From EMA For Orphan Drug Designation For RX-3117
Camurus Announces EMA Validation Of CAM2038 Marketing Authorization Application For Treatment Of Opioid Dependence
Pluristem Therapeutics Receives Positive Feedback From FDA And EMA As Company Prepares For Phase III Trial Of PLX-PAD To Support Recovery From Hip Fracture