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Clinical - Marketing Authorization Application (MAA)
GlaxoSmithKline (GSK) Seeks Approval For First Ever Malaria Vaccination 7/25/2014
Allergan Inc. (AGN) Announces OZURDEX® (Dexamethasone 700 mcg Intravitreal Implant In Applicator) Receives European Positive Opinion For The Treatment Of Diabetic Macular Edema 7/25/2014
European CHMP Adopts Positive Opinion For Gilead Sciences, Inc. (GILD)’s Zydelig® (Idelalisib) For The Treatment Of Chronic Lymphocytic Leukemia And Follicular Lymphoma 7/25/2014
Alexion Pharmaceuticals Inc. (ALXN) Release: European Medicines Agency Accepts Marketing Authorization Application For Asfotase Alfa As A Treatment For Patients With Hypophosphatasia 7/24/2014
Bioniche Life Sciences Inc. (BNC) Announces Intention To File For Marketing Approval Of MCNA In The United States 7/18/2014
Basilea Pharmaceutica (BSLN.SW) Isavuconazole European Marketing Authorization Application For The Treatment Of Invasive Mold Infections 7/17/2014
Sigma-Tau Rare Disease Submits Application To The European Medicines Agency For Use Of PegylatedL-Asparaginase (Oncaspar®) In The Treatment Of Acute Lymphoblastic Leukaemia 7/10/2014
Shenzhen Beike Biotechnology Co. Ltd. Release: Biotech Company Receives Application Approval From Chinese Food And Drug Administration 7/10/2014
Sunesis Pharmaceuticals, Inc. (SNSS) Announces European Medicines Agency Acceptance Of Pediatric Investigation Plan For Qinprezo™ (Vosaroxin) For AML 7/9/2014
Teva Pharmaceutical Industries Limited (TEVA) Receives CHMP Positive Opinion For Seasonique® Extended-Regimen Contraceptive For Marketing Authorization In Several European Countries 7/7/2014
AcelRx Pharmaceuticals (ACRX) And Grunenthal Announce Submission Of European Marketing Authorization Application For ZALVISO™ 7/7/2014
The Medicines Company (MDCO) Receives Market Authorization Renewal For Angiox® (Bivalirudin) From The European Medicines Agency And The European Commission 7/7/2014
GlaxoSmithKline (GSK) And Genmab A/S (GEN.CO) Receive EU Authorization For Arzerra™ (Ofatumumab) As First-Line Treatment For Chronic Lymphocytic Leukemia (CLL) In Combination With Chlorambucil Or Bendamustine For Patients Ineligible For Fludarabine-Based Therapy 7/3/2014
Boehringer Ingelheim Corporation Submits Applications In Europe For Tiotropium + Olodaterol Respimat® Fixed-Dose Combination In COPD 7/2/2014
TiGenix Release: European Medicines Agency Renews Marketing Authorization For Chondrocelect 7/1/2014
Ipsen (IPN.PA) Submits Marketing Authorization Applications In The U.S. And Europe For Somatuline® (Lanreotide) In The Treatment Of Gastroenteropancreatic Neuroendocrine Tumors (GEP-Nets) 7/1/2014
pSivida Corp (PSDV) Reports Positive Regulatory Outcome For Iluvien®; Moves To National Phase For Marketing Authorizations In 10 More EU Countries 7/1/2014
GE Healthcare Release: CHMP Recommends EU Approval Of VIZAMYL™ (Flutemetamol F18 Injection) For PET Imaging Of Beta Amyloid Plaque 6/30/2014
MSD’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review In Europe For The Treatment Of Advanced Melanoma 6/30/2014
Eisai Company, Ltd. (ESALY.PK) Submits First Marketing Authorization Application For Anticancer Agent Lenvatinib In Japan 6/27/2014
Bristol-Myers Squibb Company (BMY), Pfizer Inc. (PFE)'s Clot Drug Eliquis® Gets EU Green Light For Wider Use 6/27/2014
Eli Lilly and Company (LLY), Boehringer Ingelheim Corporation Win EU Backing For Copy Of Sanofi (France) (SAN.PA)'s Top Insulin Lantus 6/27/2014
Regeneron Pharmaceuticals, Inc. (REGN)'s Injection Eylea Recommended For Approval By CHMP 6/27/2014
Roche (RHHBY)'s Avastin: First Biologic Backed In EU For Resistant Ovarian Cancer 6/27/2014
Janssen-Cilag International NV (JNJ) Submits EU Marketing Application For VELCADE® (Bortezomib) In Mantle Cell Lymphoma 6/27/2014
Bristol-Myers Squibb Company (BMY)'s Hepatitis C Drug Daklinza Receives Positive CHMP Opinion 6/27/2014
Vertex Pharmaceuticals (MA) (VRTX) Grabs EU Recommendation For KALYDECO™ (Ivacaftor) In Eight Non-G551D Gating Mutations 6/27/2014
BioSpecifics Technologies Corporation (BSTC) Announces Filing By Swedish Orphan Biovitrum For EU Approval Of XIAPEX For Peyronies Disease 6/26/2014
Hyperion Therapeutics Announces European Medicines Agency Acceptance For Review Of Marketing Authorization Application For RAVICTI® 6/26/2014
Auxilium Pharmaceuticals (AUXL) Release: Swedish Orphan AB Files For EU Approval Of Xiapex For Peyronies Disease 6/25/2014
pSivida Corp (PSDV) Announces ILUVIEN® Receives Marketing Authorization In Italy For Treatment Of Chronic Diabetic Macular Edema 6/23/2014
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization In Italy For The Treatment Of Chronic Diabetic Macular Edema 6/23/2014
European Medicines Agency Validates Marketing Authorization Applications For AbbVie (ABBV)'s Investigational, All-Oral, Interferon-Free Therapy For The Treatment Of Genotype 1 Chronic Hepatitis C 6/17/2014
Enanta Pharmaceuticals, Inc. Announces European Medicines Agency Validates Marketing Authorization Applications For AbbVie (ABBV)’s Investigational, All-Oral, Interferon-Free Regimen For Genotype 1 Chronic Hepatitis C 6/17/2014
Regeneron Pharmaceuticals, Inc. (REGN) Release: EYLEA® (Aflibercept) Injection Submitted For EU Marketing Authorization For The Treatment Of Patients With Macular Edema Secondary To Branch Retinal Vein Occlusion (BRVO) 6/11/2014
European Medicines Agency Accepts Boehringer Ingelheim Corporation's Marketing Authorization Application For Nintedanib For IPF 6/5/2014
Vanda Pharmaceuticals, Inc. (VNDA) Release: European Medicines Agency Accepts HETLIOZ™ (Tasimelteon) Marketing Authorization Application For Non-24-Hour Sleep-Wake Disorder In The Totally Blind 6/3/2014
Protein Sciences Corporation Partners File For Marketing Approval Of Flublok® Influenza Vaccine In Japan 6/2/2014
Eisai Company, Ltd. (ESALY.PK) Receives Positive Opinion From European Medicines Agency's CHMP On Expanding 5/27/2014
EU Changes Its Tune On PTC Therapeutics, Inc. (PTCT) Drug, Shares Rocket 30.74% At Market Close (May 23, 2014) 5/27/2014
Despite Rejection, Teva Pharmaceutical Industries Limited (TEVA) And Active Biotech AB (BTPC) Remain Committed To The Development Of Multiple Sclerosis Nerventra® 5/23/2014
European Medicines Agency Recommends Approval Of Roche (RHHBY)'s Gazyvaro For Chronic Lymphocytic Leukaemia 5/23/2014
CHMP Adopts Positive Opinion For Biogen Idec, Inc. (Massachusetts) (BIIB)'s PLEGRIDY™ (Peginterferon Beta-1a) As A Treatment For Multiple Sclerosis In The European Union 5/23/2014
GlaxoSmithKline (GSK) And Genmab A/S (GEN.CO) Receive CHMP Positive Opinion For Arzerra™ In Combination With Chlorambucil Or Bendamustine As A First-Line Treatment For Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Not Eligible For Fludarabine-Based Therapy 5/23/2014
Veloxis Pharmaceuticals A/S (VELO) Receives Positive Opinion From CHMP For Envarsus® For Treatment Of Both Kidney And Liver Transplant Patients 5/22/2014
Merck & Co., Inc. (MRK), Endocyte, Inc. (ECYT) Withdraw Marketing Applications For Ovarian Cancer Drug 5/21/2014
Janssen-Cilag International NV (JNJ) Release: OLYSIO™ (Simeprevir) Receives Marketing Authorization In The European Union For The Treatment Of Adults With Hepatitis C Genotype 1 And 4 Infection 5/16/2014
Theravance, Inc. (THRX) Release: Anoro® (Umeclidinium/Vilanterol) Gains Marketing Authorization in Europe For The Treatment Of COPD 5/8/2014
AbbVie (ABBV) Submits For EU Marketing Authorization Its Investigational, All-Oral, Interferon-Free Therapy For The Treatment Of Chronic Hepatitis C 5/8/2014
Enanta Pharmaceuticals, Inc. Announces Submission Of EU Marketing Authorization Applications To European Medicines Agency For All-Oral, Interferon-Free Hepatitis C Regimen Containing ABT-450 5/8/2014
Pierre Fabre Obtains European Commission Marketing Authorization For Hemangiol®, The First And Only Drug Approved For The Treatment Of Proliferating Infantile Hemangioma 5/5/2014
Orion Corporation Receives First Marketing Authorisations For Bufomix Easyhaler® Product 4/15/2014
Newron Pharmaceuticals (NWRN) Release: Safinamide Application For Authorization Submitted To Swissmedic 4/7/2014
RedHill Biopharma Ltd. (RDHL) Announces Positive European Scientific Advice Meeting Regarding RHB-102 And Plans To Submit A European Marketing Application 4/7/2014
Keryx Biopharmaceuticals (KERX) Announces European Medicines Agency Validation Of Marketing Authorization Application For Zerenex™ 4/2/2014
European Medicines Agency Validates Gilead Sciences, Inc. (GILD)’s Marketing Application For Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet For Genotype 1 Chronic Hepatitis C Infection 3/28/2014
Shire Submits INTUNIV (Guanfacine Extended Release) Marketing Authorisation Application To European Medicines Agency 3/27/2014
GlaxoSmithKline (GSK) Melanoma Drug Combination Faces Delay In Europe 3/26/2014
Merck & Co., Inc. (MRK), Endocyte, Inc. (ECYT) Cancer Products Get Thumbs Up From EU Committee CHMP 3/21/2014
Medivir AB (MVRBF): Simeprevir Receives Positive CHMP Opinion For The Treatment Of Adults With Chronic Hepatitis C In The European Union 3/21/2014
Navidea Biopharmaceuticals (NAVB) Provides Update On European Marketing Authorization Application For Lymphoseek® 3/20/2014
Keryx Biopharmaceuticals (KERX) Announces Submission Of A Marketing Authorization Application For Zerenex™ To The European Medicines Agency 3/10/2014
Bayer HealthCare (BAY) And Regeneron Pharmaceuticals, Inc. (REGN) Announce Regulatory Submission Of EYLEA® (Aflibercept) Injection For The Treatment Of Diabetic Macular Edema In Japan 3/3/2014
CHMP Issues Positive Opinion For Tablet Formulation Of Merck & Co., Inc. (MRK)’s NOXAFIL® (posaconazole) 2/28/2014
European Medicines Agency Accepts Marketing Authorization Application For The Medicines Company (MDCO)'s Oritavancin 2/27/2014
Cubist Pharmaceuticals, Inc. (CBST) Announces European Medicines Agency Acceptance Of Tedizolid Marketing Authorization Application For Review 2/27/2014
Teva Pharmaceutical Industries Limited (TEVA) Receives CHMP Positive Opinion For Duoresp® Spiromax® For The Treatment Of Patients Diagnosed With Asthma And COPD In Europe 2/21/2014
Janssen-Cilag International NV (JNJ) Release: VOKANAMET™ (Canagliflozin And Metformin Fixed Dose Combination) Receives Positive CHMP Opinion Recommending Approval In The European Union For The Treatment Of Adults With Type 2 Diabetes[1] 2/21/2014
BioMarin Pharmaceutical Inc. (BMRN) Receives Positive Opinion From The CHMP In The European Union For VIMIZIM™ (Elosulfase Alfa) For Morquio A Syndrome 2/20/2014
GlaxoSmithKline (GSK)'s Anoro® (umeclidinium / vilanterol) Receives Positive Opinion From The CHMP In Europe For The Treatment Of COPD 2/20/2014
Shire plc Submits Elvanse® (Lisdexamfetamine Dimesylate) For An Adult Licence In The UK, Denmark And Sweden 2/19/2014
Dynavax Technologies Corporation (DVAX) Announces Withdrawal Of European Marketing Application For HEPLISAV™ 2/18/2014
MSD Animal Health Receives Marketing Authorization From European Commission for BRAVECTO™ (fluralaner) 2/17/2014
Arena Pharmaceuticals, Inc. (ARNA) Announces Filing For Marketing Authorization Of BELVIQ® (lorcaserin HCl) In Brazil 2/12/2014
Vectura Group plc (VEC.L): Belgian Regulatory Authority Confirm Approval Of AirFluSal® Forspiro® 2/12/2014
Vectura Group plc (VEC.L): Bulgarian Regulatory Authority Confirm Approval Of Airflusal® Forspiro® 2/4/2014
XBiotech USA, Inc. And European Medicines Agency Agree On Phase III Registration Study For Treatment Of Colorectal Cancer 1/30/2014
Sinovac Biotech Ltd. (SVA) Files Clinical Trial Application With CFDA For Its Proprietary Vaccine Against Avian Influenza A(H7N9) Virus 1/29/2014
Vectura Group plc (VEC.L) Romanian Regulatory Authority Confirm Approval Of Airflusal® Forspiro® 1/29/2014
Novartis AG (NVS)'s Potential Blockbuster Serelax Suffers Huge Setback 1/27/2014
Teva Pharmaceutical Industries Limited (TEVA), Active Biotech AB (BTPC)'s NERVENTRA® Fails To Win European Medicines Agency Backing; Both Companies Remain Committed To The Drug 1/24/2014
PTC Therapeutics, Inc. (PTCT) Slammed As EU Panel Recommends Against Muscular Disorder Drug 1/24/2014
Endocyte, Inc. (ECYT) Provides Update On CHMP Review Of Pending EU Conditional Marketing Authorization Applications For Vintafolide And Etarfolatide 1/24/2014
FINOX Biotech Release: CHMP Adopts Positive Opinion For BEMFOLA® For Treatment Of Infertility 1/23/2014
Skyepharma PLC (SKYEF) Release: Positive Step Towards Marketing Authorisation For Flutiform® In Spain 1/22/2014
Europe Approves Gilead Sciences, Inc. (GILD)'s Hot, New Hepatitis C Pill 1/20/2014
Cytonet GmbH & Co. KG Submits European Approval Application For Liver Cell Therapy To Treat Urea Cycle Disorders In Children 1/16/2014
European Medicines Agency Accepts Marketing Authorization Application For Biovest International, Inc.’s Cancer Vaccine For Treatment Of Non-Hodgkin’s Follicular Lymphoma 1/13/2014
Bristol-Myers Squibb Company (BMY) Release: Daclatasvir Marketing Authorization Application For Treatment Of Chronic Hepatitis C Validated For Accelerated Regulatory Review By European Medicines Agency 1/8/2014
Daiichi Sankyo, Inc. (4568.t) Submits Edoxaban Marketing Authorization Application To The EMA For Once-Daily Use For Stroke Prevention In Atrial Fibrillation And For The Treatment And Prevention Of Recurrence Of Venous Thromboembolism 1/7/2014
European Medicines Agency Accepts Otsuka America Pharmaceutical, Inc.'s Marketing Authorisation Application (MAA) For Tolvaptan, An Investigational Compound For Autosomal Dominant Polycystic Kidney Disease (ADPKD) 12/27/2013
European Medicines Agency Accepts Marketing Authorization Application For The Medicines Company (MDCO)'s Cangrelor 12/23/2013
European Medicines Agency Postpones Decision On Teva Pharmaceutical Industries Limited (TEVA)'s MS Pill Laquinimod 12/23/2013
European Medicines Agency Accepts Marketing Authorization Application For Durata Therapeutics, Inc.  (DRTX)'s Dalbavancin 12/23/2013
Navidea Biopharmaceuticals (NAVB) Release: European Medicines Agency Continues Marketing Authorization Application (MAA) Review For Lymphoseek® 12/20/2013
Apricus Biosciences (APRI) Announces National Phase Approval For Erectile Dysfunction Cream - Vitaros® In France 12/20/2013
Active Biotech AB (BTPC) Release: Laquinimod CHMP/European Medicines Agency Opinion 12/20/2013
Recipharm AB Subsidiary Files Infectious Disease Drug Application In European Markets Drug Product Developed Through Partnership With Astimex Pharma AB 12/16/2013
Newron Pharmaceuticals (NWRN) Release: Safinamide Marketing Authorization Application (MAA) Submitted To The European Medicines Agency 12/5/2013
U.K. Cost Agency Seeks More Lemtrada Data From Sanofi (France) (SAN.PA) 12/5/2013
Durata Therapeutics, Inc.  (DRTX) Submits Marketing Authorization Application For Dalbavancin 12/3/2013
Protectimmun Gets Positive Scientific Advice Response From European Medicines Agency For Innovative Allergy Prophylaxis 12/3/2013
CHMP Recommends Otsuka Pharmaceutical Co., Ltd.'s Deltyba™ (Delamanid) For EU Approval For Treatment Of Multidrug-Resistant Tuberculosis (MDR-TB) In Combination With Optimized Background Regimen (OBR) 11/25/2013
Ariad Pharmaceuticals, Inc. (ARIA) Announces Positive Opinion By The European Medicines Agency On The Continued Availability Of Iclusig In Patients With Leukaemias 11/22/2013
ViiV Healthcare Release: Tivicay® (dolutegravir) Receives Positive CHMP Opinion In Europe For The Treatment Of HIV 11/22/2013
AstraZeneca PLC (AZN) And Bristol-Myers Squibb Company (BMY) Release: Xigduo™ (Dapagliflozin And Metformin Hydrochloride) Receives Positive CHMP Opinion In The European Union For The Treatment Of Type 2 Diabetes 11/22/2013
European CHMP Adopts Positive Opinion for Gilead Sciences, Inc. (GILD)’ Sovaldi® For The Treatment Of Chronic Hepatitis C Infection 11/22/2013
Biogen Idec, Inc. (Massachusetts) (BIIB) Release: CHMP Determines Dimethyl Fumarate In TECFIDERA® To Be A New Active Substance In The European Union 11/22/2013
European Medicines Agency Accepts Marketing Authorization Application For The Medicines Company (MDCO)'s Fibrocaps Hemostatic Agent 11/22/2013
Celgene International Sárl (CELG) Receives Positive CHMP Opinion For ABRAXANE® In Combination With Gemcitabine As Treatment For Patients With Metastatic Pancreatic Cancer 11/22/2013
RedHill Biopharma Ltd. (RDHL) Announces Positive Scientific Advice Meeting And European Marketing Application Strategy For RHB-103 (Migraine) 11/18/2013
Boehringer Ingelheim Corporation Submits Applications In Europe To Extend The Indication For The Use Of Tiotropium Respimat® To The Treatment Of Asthma In Adults Aged 18 Years And Over 11/13/2013
Bayer AG (BAYN.DE) Submits VEGF Trap-Eye (aflibercept solution for injection) for Treatment of Diabetic Macular Edema in the EU 11/7/2013
Janssen-Cilag International NV (JNJ) Release: New Marketing Authorisation Application Submitted to European Medicines Agency for Ibrutinib for the Treatment of Two Forms of Blood Cancer 10/30/2013
Actelion Ltd. (ALIOF.PK) and Lundbeck Inc. (LUN.CO) Get Positive CHMP Opinions 10/28/2013
H. Lundbeck A/S (LUN.CO) Receives Positive Opinion for Approval of Brintellix (Vortioxetine) in the European Union 10/25/2013
Gentium S.p.A. Receives Marketing Authorization From the European Commission (EC) for Defitelio® (Defibrotide) 10/22/2013
Janssen-Cilag International NV (JNJ) Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir With Cobicistat 10/15/2013
Boehringer Ingelheim Corporation Submits Nintedanib, a Novel Oncology Compound, for European Approval 10/14/2013
Gentium S.p.A. Receives Positive Opinion From European Medicines Agency's COMP for Defibrotide for the Prevention of GvHD 10/11/2013
GlaxoSmithKline (GSK) and Genmab A/S (GEN.CO) Announce European Submission to Regulatory Authorities for Arzerra® (Ofatumumab) as 1st Line Treatment of Chronic Lymphocytic Leukemia (CLL) 10/4/2013
Orexigen Therapeutics, Inc. (OREX) Submits Contrave Marketing Authorization Application to European Medicines Agency 10/3/2013
Omeros Corporation (OMER) Release: U.S. and European Regulators Accept for Review OMS302 Marketing Applications 10/2/2013
Nektar Therapeutics (CA) (NKTR) Reports that Partner AstraZeneca PLC (AZN) Announced European Medicines Agency Acceptance of Marketing Authorisation Application for Naloxegol 9/30/2013
Furiex Pharmaceuticals, Inc. (FURX) Confirms Takeda Pharmaceutical Co. Ltd. (TKPYY) Receives European Marketing Authorization for VIPIDIA™ (alogliptin), VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone) 9/24/2013
Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Receives Marketing Authorization From the European Commission (EC) for Additional Revolade™ (Eltrombopag) Indication as the First Approved Treatment for Chronic Hepatitis C-Associated Thrombocytopenia 9/24/2013
Novo Nordisk A/S (NVO) Hemophilia-A Treatment Wins EU Panel Backing 9/20/2013
Otsuka Pharmaceutical Co., Ltd. and Lundbeck Inc. (LUN.CO) Receive Positive CHMP Opinion in Europe for Abilify Maintena™, a Once-Monthly Injectable for Schizophrenia 9/20/2013
Xofigo® (radium Ra 223 dichloride) Injection Recommended for Approval in the European Union 9/20/2013
Dendreon Corporation (DNDN) Announces Marketing Authorization for PROVENGE® in the European Union 9/17/2013
Swissmedic Accepts for Review Basilea Pharmaceutica (BSLN.SW)'s Ceftobiprole Marketing Authorization Application for the Treatment of Pneumonia 9/16/2013
Raptor Pharmaceutical Inc. (RPTP) Receives Marketing Authorization for PROCYSBI® in European Union 9/12/2013
NanoViricides, Inc. (NNVC.PK) Reports That the DengueCide™ Orphan Drug Application has Been Submitted and Received by the European Medicines Agency 9/3/2013
Apricus Biosciences (APRI) Receives National Phase Approvals for Vitaros® in Ireland and the Netherlands 8/15/2013
Teva Pharmaceutical Industries Limited (TEVA) Receives European Marketing Authorization for Lonquex® (XM22 lipegfilgrastim) 8/8/2013
Bavarian Nordic (BAVA.CO) Receives European Marketing Authorization for IMVANEX Smallpox Vaccine 8/7/2013
Skyepharma PLC (SKYEF) Release: flutiform® Recommended for Approval in Japan 7/31/2013
First in Class Once-Daily Dual Bronchodilator Ultibro® Breezhaler® (QVA149) Gains Positive CHMP Opinion for the Treatment of COPD 7/29/2013
Gentium S.p.A. Receives Positive Opinion From European Medicines Agency's CHMP for Defitelio 7/26/2013
Furiex Pharmaceuticals, Inc. (FURX) Confirms Takeda Pharmaceutical Co. Ltd. (TKPYY) Receives Positive CHMP Opinion for VIPIDIA™ (alogliptin) and Fixed-Dose Combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone) 7/26/2013
Boehringer Ingelheim Corporation's Afatinib Receives Positive CHMP Opinion for Patients With EGFR Mutation Positive Lung Cancer in European Union 7/26/2013
Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Receives Positive CHMP Opinion for REVOLADE™ in Thrombocytopenia Associated with Chronic Hepatitis C Infection 7/26/2013
Otsuka Pharmaceutical Co., Ltd. Receives Opinion From CHMP on Delamanid 7/26/2013
Merck & Co., Inc. (MRK) Statement Regarding CHMP Review of Incretin-Based Therapies for Type 2 Diabetes, Including Sitagliptin 7/26/2013
Regeneron Pharmaceuticals, Inc. (REGN) Release: EYLEA® (aflibercept) Injection Recommended for Approval for the Treatment of Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion in Europe 7/26/2013
CHMP Confirms Prior Opinion Regarding Marketing Authorization in Europe for Pfizer Inc. (PFE)'s XELJANZ® (tofacitinib citrate) 7/26/2013
Novartis AG (NVS) Vaccine Division Hit by Bexsero Setback 7/24/2013
Biological E. Limited's Japanese Encephalitis Vaccine Prequalified by the World Health Organization 7/22/2013
NanoViricides, Inc. (NNVC.PK) Receives Notification That Clinical Coordinators Have Been Appointed by the European Medicines Agency to Review the Company's Upcoming DengueCide Orphan Drug Designation Application 7/22/2013
Biogen Idec, Inc. (Massachusetts) (BIIB) Release: US and EU Regulatory Authorities Accept PLEGRIDY™ (peginterferon beta-1a) Marketing Applications for Review 7/19/2013
Alexion Pharmaceuticals Inc. (ALXN)'s Soliris® (eculizumab) Receives Positive Opinion From the Committee for Orphan Medicinal Products for Treatment of Neuromyelitis Optica (NMO) 7/16/2013
Eli Lilly and Company (LLY) and Boehringer Ingelheim Corporation Announce Regulatory Submission for New Insulin Glargine Biosimilar Product 7/10/2013
European Medicines Agency Approves Positive Opinion on Omeros Corporation (OMER)' Pediatric Investigation Plan for OMS302 7/2/2013
Emergent BioSolutions (EBS) Receives Paul-Ehrlich-Institut Approval to Market BioThrax in Germany 7/1/2013
Sanofi (France) (SAN.PA)'s MS Drugs Get Double Boost in Europe 6/28/2013
Dendreon Corporation (DNDN) Surges After Cancer Drug Gets European Backing, Stock Up +0.1701 (4.17%) @10:07 AM ET 6/28/2013
Genzyme Corporation (GENZ) Receives Positive CHMP Opinion for LEMTRADA™ (alemtuzumab) in Europe 6/28/2013
Raptor Pharmaceutical Inc. (RPTP)'s PROCYSBI™ Receives Positive Recommendation From CHMP 6/28/2013
Halozyme Therapeutics, Inc. (HALO) Announces Positive Opinion From CHMP on Roche (RHHBY)'s Herceptin SC for European Approval 6/28/2013
CHMP Gives a Positive Opinion for the Use of Janssen-Cilag International NV (JNJ)'s VELCADE® as Retreatment and for Frontline Induction Therapy Before Stem Cell Transplantation 6/28/2013
First Copy of Johnson & Johnson (JNJ)'s $6 Billion Remicade Wins European Medicines Agency Backing 6/28/2013
Valneva Release: ACIP Unanimously Votes to Extend the Recommendations for Use of IXIARO® Vaccine 6/21/2013
Immune Response BioPharma to Seek Approval of REMUNE With MCC of South Africa 6/18/2013
Alimera Sciences (ALIM) Announces Issuance of a Positive Appraisal Recommendation on ILUVIEN® for Consultation in the United Kingdom 6/14/2013
Cangene Corporation (CC:CNJ) Withdraws MAA for Investigational Hemophilia Compound 6/14/2013
pSivida Corp (PSDV) Announces UK's National Institute for Clinical Excellence (NICE) Says Yes to ILUVIEN® in Some Patients With Diabetic Macular Edema in New Draft Guidance 6/13/2013
ThromboGenics NV (TBGNF)' JETREA® Receives Positive Initial National Institute for Clinical Excellence (NICE) Recommendation for Vitreomacular Traction and Macular Hole 6/12/2013
Gentium S.p.A. Provides Update on Re-Examination of Defibrotide MAA to EMA 6/4/2013
Teva Pharmaceutical Industries Limited (TEVA)'s Lonquex®(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN) 6/3/2013
EU Agency Calls for Curbs on GlaxoSmithKline (GSK), Valeant Pharmaceuticals International (VRX) Epilepsy Drug 5/31/2013
Oral Anti-Cancer Therapy Pomalidomide Celgene International Sárl (CELG) Receives Positive CHMP Opinion as Treatment for Patients With Relapsed and Refractory Multiple Myeloma 5/31/2013
Novo Nordisk A/S (NVO) Files for Regulatory Approval of IDegLira in the EU for the Treatment of Type 2 Diabetes 5/31/2013
BioPartners GmbH Release: Positive CHMP Opinion for Once-Weekly Somatropin Biopartners 5/31/2013
Bavarian Nordic (BAVA.CO)'s IMVANEX® Smallpox Vaccine Receives Positive Opinion From European Regulatory Authorities 5/31/2013
European Medicines Agency Recommends Approval of Aegerion Pharmaceuticals, Inc. (AEGR)'s Pomalidomide for the Treatment of Multiple Myeloma 5/31/2013
AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) (AVEO) Drops as Astellas Pharma Inc. (YPH.BE) Will Not Seek Nod for Kidney Cancer Drug 5/28/2013
Astellas Pharma Inc. (YPH.BE) and Medivation, Inc. (MDVN) Announce Submission of Application for Marketing Approval of Enzalutamide, an Oral Androgen Receptor Inhibitor, in Japan 5/24/2013
European Medicines Agency Validates Gilead Sciences, Inc. (GILD)'s Marketing Application for Sofosbuvir for the Treatment of Hepatitis C 5/22/2013
European Medicines Agency Accepts Veloxis Pharmaceuticals A/S (VELO)' Marketing Authorization Application (MAA) for LCP-Tacro for Treatment of Kidney Transplant Patients 5/22/2013
Baxter International, Inc. (BAX) Receives Marketing Authorization for HyQvia in European Union 5/21/2013
Arena Pharmaceuticals, Inc. (ARNA) Withdraws Diet Drug Application in Europe 5/3/2013
Omeros Corporation (OMER) Ophthalmology Product OMS302 Granted Eligibility for European Centralized Review 4/30/2013
Pfizer Inc. (PFE)'s Arthritis Drug Rejected by European Regulators 4/29/2013
Veloxis Pharmaceuticals A/S (VELO) Announces Submission of Marketing Authorization Application (MAA) to European Medicines Agency (EMA) for LCP-Tacro™ for Treatment of Kidney Transplant Patients 4/29/2013
AVANIR Pharmaceuticals (AVNR) Receives Positive CHMP Opinion for Approval of NUEDEXTA in Europe 4/29/2013
Astellas Pharma Inc. (YPH.BE), Medivation, Inc. (MDVN) Release: Positive CHMP Opinion for Xtandi ™ (Enzalutamide) in Advanced Prostate Cancer 4/26/2013
Curis, Inc. (CRIS) Announces Erivedge® Receives Positive CHMP Opinion for Conditional Approval in European Union 4/26/2013
Janssen Research & Development Release: INCIVO® Receives Positive Opinion From the Committee for Medicinal Products for Human Use (CHMP) for Twice Daily Dosing for Treatment of Genotype-1 Hepatitis C Virus 4/26/2013
Celgene (CELG) Release: Oral Anti-Cancer Therapy REVLIMID® Receives Positive CHMP Opinion as Treatment for Patients With Form of Rare Blood Cancer Deletion 5Q Myelodysplastic Syndromes 4/26/2013
VIVUS, Inc. (VVUS) Announces Positive Recommendation From CHMP Supporting Avanafil Approval in Europe 4/26/2013
Medivir AB (MVIRb.F): Marketing Authorization Application for Simeprevir to the European Medicines Agency for the Treatment of Patients With Genotype 1 and Genotype 4 Hepatitis C is Now Filed 4/24/2013
Arena Pharmaceuticals, Inc. (ARNA) Announces Eisai Inc. (ESALF.PK)'s Submission of BELVIQ® (lorcaserin HCl) Marketing Authorization Application in Mexico 4/1/2013
Pfizer Inc. (PFE)'s BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From the European Commission (EC) 3/28/2013
European Medicines Agency Accepts MAA Submission of Shionogi, Inc.'s Ospemifene for the Treatment of VVA 3/27/2013
European Medicines Agency Accepts Marketing Authorization Application for Boehringer Ingelheim Corporation and Eli Lilly and Company (LLY)'s Empagliflozin, an Investigational Type 2 Diabetes Treatment 3/26/2013
Biogen Idec, Inc. (Massachusetts) (BIIB) Multiple Sclerosis Drug Wins EU Agency's Backing 3/25/2013
Sanofi (France) (SAN.PA) Gets EU Panel Backing for Multiple Sclerosis Pill Aubagio 3/22/2013
Gentium S.p.A. Receives Negative Opinion From the CHMP on Defibrotide for the Treatment and Prevention of VOD 3/22/2013
European CHMP Adopts Positive Opinion for Gilead Sciences, Inc. (GILD)'s Stribild®, a Once-Daily, Integrase Inhibitor-Based, Single Tablet Regimen for the Treatment of HIV-1 Infection 3/22/2013
Vanda Pharmaceuticals, Inc. (VNDA) Withdraws EU Filing for Schizophrenia Drug 3/15/2013



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