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Clinical - Marketing Authorization Application (MAA)
Amgen (AMGN) Receives Positive CHMP Opinion For Use Of Repatha (Evolocumab) For The Treatment Of High Cholesterol 5/22/2015
Omeros Corporation (OMER) Release: Omidria Receives Positive Opinion From European Medicines Agency's Committee For Medicinal Products For Human Use 5/22/2015
Merck & Co. (MRK) Receives Positive CHMP Opinion For KEYTRUDA (pembrolizumab) For The Treatment Of Advanced Melanoma 5/22/2015
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion In The European Union For Nivolumab (Opdivo, Nivolumab BMS) For The Treatment Of Advanced Squamous Non-Small Cell Lung Cancer In Previously-Treated Patients 5/22/2015
United Therapeutics Corporation (UTHR) Release: European Medicines Agency Recommends Treatment For Rare Cancer In Children 5/22/2015
Pharmacyclics (PCYC) Release: European Medicines Agency Issues Positive Opinion, Recommends Full Approval of IMBRUVICA (ibrutinib) To Treat Waldenstrom's Macroglobulinemia 5/22/2015
Amgen (AMGN) Beats Sanofi (SAN.PA) to Market with EU Hurdle for Anti-Cholesterol Drug 5/22/2015
Janssen-Cilag International NV (JNJ) Release: STELARA Receives CHMP Positive Opinion For Treatment Of Adolescents With Moderate To Severe Psoriasis In Europe 5/22/2015
Baxter International (BAX) Files For European Approval Of Investigational 20% Subcutaneous Immune Globulin Treatment For Primary Immunodeficiency 5/21/2015
Amgen (AMGN), Sanofi (SAN.PA) in Race to Get European Green light for Anti-Cholesterol Drugs 5/21/2015
European Medicines Agency Grants Kiadis Pharma's Lead Product ATIR ATMP Certificate For Quality And Non-Clinical Data 5/13/2015
EspeRare's Investigational Compound Rimeporide Receives European Orphan Drug Designation In Duchenne Muscular Dystrophy 5/4/2015
European Medicines Agency Grants Orphan Designation For Makindus' MI-100 For Stargardt's Disease 5/4/2015
Sobi Release: Early Treatment And A Longer Life - New Orfadin Formats Meet New Patient Needs 5/4/2015
PharmaEngine, Inc. Announces Filing By Baxter BioScience Corporation (BAX) Of Marketing Authorization Application Of MM-398 (PEP02) To The European Medicines Agency For Post-Gemcitabine Metastatic Pancreatic Cancer Patients 5/4/2015
Oncolytics Biotech Inc. (ONC.TO) Announces Receipt Of Orphan Drug Status From The European Medicines Agency For Pancreatic Cancer 4/29/2015
Valeant (VRX) Release: RELISTOR Receives Positive CHMP Opinion In The EU For The Treatment Of Opioid-Induced Constipation In Adults With Chronic Non-Cancer Pain 4/24/2015
Vanda Pharmaceuticals, Inc. (VNDA) Receives Positive CHMP Opinion For HETLIOZ (Tasimelteon) For The Treatment Of Non-24-Hour Sleep-Wake Disorder In The European Union 4/24/2015
Alimera Sciences (ALIM)' ILUVIEN Receives 17th European Marketing Authorization; Completing Second Wave Of Country Approvals 4/14/2015
Repros Therapeutics Inc. (RPRX) Receives Confirmation Of Eligibility For Submission Of A Centralized Marketing Authorization Application To The European Medicines Agency As A New Active Substance 4/7/2015
European Regulators Postpone Bristol-Myers Squibb (BMY)’s Opdivo Decision Until April or Later, As Markets Wait Anxiously 3/31/2015
Synageva BioPharma (GEVA) Submits Kanuma (Sebelipase Alfa) Application For LAL Deficiency In Mexico 3/30/2015
Helsinn Group Receives Positive CHMP Opinion For Akynzeo (netupitant/palonosetron) For The Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV) In The European Union 3/30/2015
Boehringer Ingelheim Release: Type 2 Diabetes: CHMP Recommends Empagliflozin/Metformin Hydrochloride For Approval In The European Union 3/30/2015
Biogen (BIIB) Announces European Medicines Agency Validation Of Marketing Authorization Application For SB2, A Biosimilar Candidate For Infliximab 3/30/2015
European Medicines Agency Commences Review Of CSL Behring's Regulatory Submission For Rix-FP For Hemophilia B Patients 3/30/2015
Otsuka Pharmaceutical Co., Ltd. Release: Pre-Filled Dual-Chamber Syringe For Abilify Maintena (Aripiprazole) Prolonged-Release Suspension For Injection, Used In The Treatment Of Schizophrenia, Receives Positive CHMP Opinion (Approval In EU) 3/30/2015
European Medicines Agency Validates Marketing Authorisation Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment Of MS 3/27/2015
Santen Pharmaceutical Announces Approval Of Ikervis For EU Marketing Authorization 3/25/2015
Amicus Therapeutics, Inc. (FOLD) Provides Positive Global Regulatory Updates From European Medicines Agency And FDA Meetings For Fabry Monotherapy 3/19/2015
VAXIL Receives EU Orphan Drug Designation For Immucin For The Treatment Of Multiple Myeloma 3/16/2015
Samsung Bioepis Submits Marketing Authorization Application For SB2, A Remicade (Infliximab) Biosimilar Candidate, To The European Medicines Agency 3/13/2015
ThromboGenics NV (TBGNF) Receives Positive CHMP Opinion For Ready Diluted Formulation Of JETREA 3/3/2015
Taiho Pharmaceutical Submits TAS-102 Marketing Authorisation Application To The European Medicines Agency For The Treatment Of Refractory Metastatic Colorectal Cancer 3/2/2015
European Medicines Agency Accepts Santen, Inc.'s Marketing Application Filing For Intravitreal Sirolimus For The Treatment Of Noninfectious Uveitis Of The Posterior Segment 3/2/2015
Celgene International Sárl (CELG) Release: ABRAXANE Approved By European Commission For First-Line Treatment Of Patients With Non-Small Cell Lung Cancer 3/2/2015
European Medicines Agency Release: Novartis AG (NVS)'s Zykadia Recommended For Approval In Advanced Non Small Cell Lung Cancer 2/27/2015
Alexion Pharmaceuticals Inc. (ALXN) Receives CHMP Positive Opinions For Important Updates To The EU Label For Soliris (eculizumab) 2/27/2015
Amgen (AMGN) Announces The European Medicines Agency Acceptance Of Kyprolis (Carfilzomib) Marketing Authorization Application For The Treatment Of Relapsed Multiple Myeloma 2/27/2015
Roche (RHHBY)’s Avastin Plus Chemotherapy Receives Positive Recommendation From CHMP For EU Approval In Advanced Cervical Cancer 2/27/2015
Tolero Pharmaceuticals Receives European Medicines Agency Orphan Drug Designation For Alvocidib For The Treatment Of Acute Myeloid Leukemia 2/26/2015
Regeneron (REGN) Release: EYLEA (aflibercept) Injection Receives EU Approval For The Treatment Of Visual Impairment Due To Macular Edema Secondary To Retinal Vein Occlusion 2/26/2015
MediGene AG (MDGEF.PK) Receives Positive Decision On Marketing Authorisation For Veregen In 8 Additional European Countries 2/20/2015
aTyr Pharma Inc. Receives European Medicines Agency Orphan Drug Designation For Resolaris In FSHD 2/18/2015
Celgene (CELG) Announces Positive Recommendation By Scottish Medicines Consortium (SMC) For ABRAXANE (Nab-Paclitaxel) In Combination With Gemcitabine1 For Patients With Metastatic Pancreatic Cancer 2/10/2015
Orexigen Therapeutics, Inc. (OREX) Provides Progress Update on Mysimba European Marketing Authorization 2/9/2015
Arena Pharmaceuticals, Inc. (ARNA) Announces Marketing Approval In South Korea Of BELVIQ® (lorcaserin HCl) For Weight Management 2/3/2015
Sucampo Pharmaceuticals, Inc. (SCMP) Release: AMITIZA® (Lubiprostone) Mutual Recognition Procedure Closes With Recommendation For Approval In European Countries 1/30/2015
Amgen (AMGN) Submits Applications In The U.S. And Europe For Kyprolis (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma 1/29/2015
Amgen (AMGN) Submits Applications for Cancer Drug Kyprolis in U.S. and Europe 1/28/2015
BioDelivery Sciences International (BDSI) Acquires North American Marketing Authorizations For ONSOLIS From MEDA 1/27/2015
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization In Finland And Luxembourg 1/27/2015
Medunik Canada Is Pleased To Announce That Health Canada Has Granted Market Authorization For Pheburane™ 1/27/2015
pSivida Corp (PSDV) Reports ILUVIEN® Receives Marketing Authorization In Two More EU Countries 1/27/2015
Merck & Co. (MRK) Announces CHMP Issues Positive Opinion For Investigational Antibiotic SIVEXTRO® (Tedizolid Phosphate) 1/26/2015
The Medicines Company (MDCO) Receives CHMP Positive Opinions For Three Hospital Acute Care Products: KENGREXAL™ (cangrelor), ORBACTIV™ (oritavancin) And RAPLIXA™ (sealant powder) 1/23/2015
European Medicines Agency Release: Novo Nordisk A/S (NVO)'s Saxenda Recommended For Approval In Weight Management In Adults 1/23/2015
Pfizer (PFE) Release: Prevenar 13®* Receives CHMP Positive Opinion For Prevention Of Vaccine-Type Pneumococcal Pneumonia in Adults 1/22/2015
European Commission (EC) Grants Marketing Authorization For Cerdelga® (Eliglustat), Genzyme Corporation (GENZ)’s Oral Therapy For Gaucher Disease Type 1 1/22/2015
European Medicines Agency Accepts Samsung Bioepis' Enbrel® Biosimilar Candidate, SB4, For Regulatory Review 1/21/2015
Enanta Pharmaceuticals, Inc. Announces European Commission (EC) Grants Marketing Authorizations For AbbVie (ABBV)’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)... 1/16/2015
Celgene International Sárl (CELG) Release: Oral OTEZLA® (Apremilast) Approved By The European Commission For The Treatment Of Both Patients With Psoriasis And Psoriatic Arthritis 1/16/2015
European Commission (EC) Grants Marketing Authorizations For AbbVie (ABBV)'s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) For The Treatment Of Chronic Hepatitis C 1/16/2015
Regeneron (REGN) And Sanofi (SAN.PA) Announce Praluent™ (alirocumab) Marketing Authorization Application Has Been Accepted For Review By European Medicines Agency 1/12/2015
Ultragenyx Pharmaceuticals (RARE) Announces Intent To File For Conditional Approval In Europe For Sialic Acid Extended-Release Tablets In Hereditary Inclusion Body Myopathy 1/12/2015
Magnus Life Science Announces Recommendation For Orphan Designation 1/8/2015
AVEO Oncology (AVEO) Receives Confirmation Of Eligibility For Submission Of A Tivozanib Marketing Authorization Application To European Medicines Agency 1/8/2015
Shield Therapeutics Announces The Acceptance For Review By The European Medicines Agency Of The Marketing Authorisation Application For Feraccru® 1/7/2015
Newron Pharmaceuticals (NWRN) Release: CHMP Recommends Approval Of Xadago™ (Safinamide) To Treat Parkinson's Disease In The EU 1/7/2015
RedHill Biopharma Ltd. (RDHL) Announces Acceptance For Review Of BEKINDA™ European Marketing Application For Oncology Support 12/31/2014
BioSpecifics Technologies Corporation (BSTC) Announces Positive Opinion By CHMP For XIAPEX® For The Treatment Of Peyronie's Disease 12/23/2014
Rock Creek Pharmaceuticals Files Clinical Trial Application In The UK For Clinical Trials Of Anatabine Citrate Formulations 12/23/2014
Synageva BioPharma (GEVA) Announces Sebelipase Alfa Marketing Authorization Application Validated By The European Medicines Agency 12/23/2014
Actavis (ACT) Release: XYDALBA™ (dalbavancin) Receives CHMP Positive Opinion For The Treatment Of Acute Bacterial Skin And Skin Structure Infections (ABSSSI) In Adults 12/22/2014
Oncolytics Biotech Inc. (ONC.TO) Announces Filing For Orphan Designation With The European Medicines Agency For Pancreatic And Ovarian Cancers 12/22/2014
Eiger Bio Receives Orphan Designation For Lonafarnib, A First In Class, Investigational Treatment For Hepatitis Delta Virus (HDV) Infection 12/22/2014
Auxilium Pharmaceuticals (AUXL) Release: Sobi's Xiapex Receives Positive Opinion By CHMP For The Treatment Of Peyronie's Disease 12/22/2014
Orexigen Therapeutics, Inc. (OREX)'s Mysimba (Naltrexone Hcl / Bupropion Hcl Prolonged Release) Receives Positive CHMP Opinion Recommending Approval For Weight Management In The European Union 12/19/2014
Celgene (CELG) Receives Positive CHMP Opinion To Extend REVLIMID® (Lenalidomide) For Continuous Use In Patients With Newly Diagnosed Multiple Myeloma And Ineligible For Transplant 12/19/2014
Newron Pharmaceuticals (NWRN) Release: CHMP Recommends Approval Of Xadago (Safinamide) To Treat Parkinson´s Disease In The EU 12/19/2014
Ligand Pharmaceuticals Inc. (LGND) Partner Pfizer (PFE) Receives European Marketing Authorization For DUAVIVE® (Conjugated Estrogens/Bazedoxifene) For Treatment Of Estrogen Deficiency Symptoms In Postmenopausal Women With A Uterus 12/19/2014
Amicus Therapeutics, Inc. (FOLD) To Submit European Marketing Application For Migalastat Monotherapy For Fabry Disease 12/11/2014
RedHill Biopharma Ltd. (RDHL) Submits BEKINDA™ (RHB-102) European Marketing Authorization Application For Oncology Support 12/9/2014
GVK Biosciences Review: Some Member States Suspend Marketing Authorisations For Concerned Medicines 12/5/2014
NPS Pharmaceuticals, Inc. (NPSP) Release: European Medicines Agency Validates Marketing Authorization Application For Natpar® (Parathyroid Hormone (rDNA)) In Hypoparathyroidism 12/2/2014
Synageva BioPharma (GEVA) Completes Rolling Submission Of Biologics License Application To The FDA For Sebelipase Alfa And Submits Marketing Authorization Application To European Medicines Agency 12/2/2014
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Announce Acceptance For Review Of European Marketing Application For RIZAPORT For Migraines 12/1/2014
Alexion Pharmaceuticals Inc. (ALXN) Release: National Institute for Clinical Excellence (NICE) Issues Final Positive Recommendation For National Commissioning Of Soliris® (Eculizumab) For All Patients With aHUS In England 12/1/2014
Pharmacyclics, Inc. (PCYC) Release: New IMBRUVICA (ibrutinib) Application Accepted By European Medicines Agency For Waldenstrom's Macroglobulinemia 12/1/2014
Alimera Sciences (ALIM)' ILUVIEN Receives Marketing Authorization In The Netherlands For The Treatment Of Chronic Diabetic Macular Edema 12/1/2014
BioTie Therapies Corp.: UK's NICE Issues Positive Final Guidance For Selincro 11/26/2014
AbbVie (ABBV) Nabs Positive CHMP Opinions For VIEKIRAX Plus EXVIERA To Treat HCV 11/24/2014
Genzyme Europe BV Cerdelga Gets EU Recommended For Approval In Type 1 Gaucher Disease 11/21/2014
Celgene (CELG) Receives Positive CHMP Opinion For OTEZLA (apremilast), The First Oral PDE4 Inhibitor For The Treatment Of Patients With Psoriasis And Psoriatic Arthritis 11/21/2014
Gilead Sciences, Inc. (GILD) Stock Rises After European Commission (EC) Market Authorization For Harvoni 11/18/2014
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization In Ireland For The Treatment Of Chronic Diabetic Macular Edema 11/17/2014
Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Announces EU Regulatory Submission For Severe Aplastic Anemia Indication For Revolade™ (Eltrombopag) 11/12/2014
GlaxoSmithKline (GSK) Submits European, U.S. Filings For Mepolizumab 11/5/2014
Biogen Idec (BIIB) And Swedish Orphan Biovitrum Announce European Medicines Agency Validates ELOCTA&#-0153; (rFVIIIFc) Marketing Authorization Application For Review 11/3/2014
Birken Release: Birken AG Accepts Marketing Authorization Application For Oleogel-S10 11/3/2014
Mundipharma AG Receives Positive CHMP Opinion For Targin® (Oxycodone / Naloxone) For The Treatment Of Restless Legs Syndrome1 10/24/2014
Astellas Pharma Inc. (ALPMY)'s XTANDI™ (Enzalutamide) Capsules Receive Positive CHMP Opinion For The Treatment Of Men With Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve 10/24/2014
Ariad Pharmaceuticals, Inc. (ARIA) Announces Adoption of Final Opinion For Iclusig By Committee For Medicinal Products For Human Use In Europe 10/24/2014
Roche (RHHBY) Release: CHMP Recommends Label Update For Esbriet In Idiopathic Pulmonary Fibrosis, Strengthening Mortality Benefit And Reinforcing Safety Profile 10/24/2014
Ariad Pharmaceuticals, Inc. (ARIA) Announces Recommendation For Iclusig By The Pharmacovigilance Risk Assessment Committee Of The European Medicines Agency 10/10/2014
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Submit European Marketing Authorization Application For Migraine Drug RIZAPORT® (Formerly RHB-103) 10/1/2014
MediGene AG (MDGEF.PK): Veregen® Marketing Authorization Process Initiated For Eight Additional European Countries 9/30/2014
Bristol-Myers Squibb Company (BMY) Release: European Medicines Agency Validates The Marketing Authorization Application For Nivolumab In Non-Small Cell Lung Cancer 9/29/2014
European Medicines Agency Release: Ketoconazole HRA recommended For Approval In Cushing's Syndrome 9/26/2014
European Commission Grants Marketing Authorization For Gilead Sciences, Inc. (GILD)’s Zydelig® (Idelalisib) For The Treatment Of Chronic Lymphocytic Leukemia And Follicular Lymphoma 9/19/2014
Alimera Sciences (ALIM)' Iluvien® Receives Tenth National Marketing Authorization For The Treatment Of Chronic Diabetic Macular Edema 9/4/2014
Regeneron Pharmaceuticals, Inc. (REGN) Announces Submission Of Application For EYLEA® (Aflibercept) Injection In Japan For Macular Edema Following Branch Retinal Vein Occlusion 9/4/2014
Prosonix' Marketing Authorisation Application For PSX1001 - A Generic Version Of GlaxoSmithKline (GSK)'s Flixotide® Evohaler® - Under Assessment In EU 9/2/2014
Amgen (AMGN) Submits Marketing Authorization Application For Cholesterol-Lowering Medication Evolocumab 9/2/2014
Amgen (AMGN) Submits Marketing Authorization Application For Talimogene Laherparepvec 9/2/2014
Acusphere Inc. (ACUS) Withdraws Its European Marketing Authorization Application For Imagify 8/28/2014
Cubist Pharmaceuticals, Inc. (CBST) Announces European Medicines Agency Acceptance Of Ceftolozane/Tazobactam Marketing Authorization Application For Review 8/22/2014
NovoCure Ltd. Announces The Submission Of A Pre-Marketing Approval Application In Japan For The NovoTTF™-100A System To Treat Recurrent Glioblastoma 8/21/2014
ThromboGenics NV (TBGNF)' JETREA Receives Positive Recommendation From Scottish Medicines Consortium (SMC) 8/11/2014
European Medicines Agency Accepts Application Seeking New Indication For Pfizer Inc. (PFE)'s Prevenar 13®1 For Prevention Of Pneumococcal Pneumonia In Adults 8/7/2014
Insmed Incorporated (INSM) Tanks As Phase 3 Plans Are Needed For ARIKAYCE, Delaying FDA Approval 8/5/2014
PTC Therapeutics, Inc. (PTCT) Receives Conditional Approval In The European Union For Translarna™ For The Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy 8/4/2014
Shares Of Biogen Idec, Inc. (Massachusetts) (BIIB) Slip As Tecfidera Hits Second Hurdle In Germany 8/4/2014
NeuroDerm Ltd. Announces Eligibility For European Union Centralized Procedure For ND0612H, A Novel Treatment For Advanced Parkinson's Disease 8/4/2014
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization In Denmark For The Treatment Of Chronic Diabetic Macular Edema 8/1/2014
pSivida Corp (PSDV) Reports ILUVIEN® For Chronic Diabetic Macular Edema Receives Marketing Authorization In Denmark, 9th EU Approval 8/1/2014
Orexigen Therapeutics, Inc. (OREX) Receives CHMP Day 180 List Of Outstanding Issues 7/30/2014
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization In Norway For The Treatment Of Chronic Diabetic Macular Edema 7/29/2014
pSivida Corp (PSDV) Announces Iluvien® Receives Marketing Authorization In Norway And Approval For Reimbursement In Portugal 7/29/2014
CHMP Issues Positive Opinion For Roche (RHHBY) RA Drug Label Expansion 7/28/2014
Veloxis Pharmaceuticals A/S (VELO) Release: Envarsus® Receives European Marketing Authorization For Treatment Of Both Kidney And Liver Transplant Patients 7/28/2014
GlaxoSmithKline (GSK) Seeks Approval For First Ever Malaria Vaccination 7/28/2014
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
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
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
Shenzhen Beike Biotechnology Co. Ltd. Release: Biotech Company Receives Application Approval From Chinese Food And Drug Administration 7/10/2014
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
Sunesis Pharmaceuticals, Inc. (SNSS) Announces European Medicines Agency Acceptance Of Pediatric Investigation Plan For Qinprezo™ (Vosaroxin) For AML 7/9/2014
The Medicines Company (MDCO) Receives Market Authorization Renewal For Angiox® (Bivalirudin) From The European Medicines Agency And The European Commission 7/7/2014
AcelRx Pharmaceuticals (ACRX) And Grunenthal Announce Submission Of European Marketing Authorization Application For ZALVISO™ 7/7/2014
Teva Pharmaceutical Industries Limited (TEVA) Receives CHMP Positive Opinion For Seasonique® Extended-Regimen Contraceptive For Marketing Authorization In Several European Countries 7/7/2014
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
pSivida Corp (PSDV) Reports Positive Regulatory Outcome For Iluvien®; Moves To National Phase For Marketing Authorizations In 10 More EU Countries 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
TiGenix Release: European Medicines Agency Renews Marketing Authorization For Chondrocelect 7/1/2014
MSD’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review In Europe For The Treatment Of Advanced Melanoma 6/30/2014
GE Healthcare Release: CHMP Recommends EU Approval Of VIZAMYL™ (Flutemetamol F18 Injection) For PET Imaging Of Beta Amyloid Plaque 6/30/2014
Bristol-Myers Squibb Company (BMY), Pfizer Inc. (PFE)'s Clot Drug Eliquis® Gets EU Green Light For Wider Use 6/27/2014
Vertex Pharmaceuticals (MA) (VRTX) Grabs EU Recommendation For KALYDECO™ (Ivacaftor) In Eight Non-G551D Gating Mutations 6/27/2014
Bristol-Myers Squibb Company (BMY)'s Hepatitis C Drug Daklinza Receives Positive CHMP Opinion 6/27/2014
Janssen-Cilag International NV (JNJ) Submits EU Marketing Application For VELCADE® (Bortezomib) In Mantle Cell Lymphoma 6/27/2014
Roche (RHHBY)'s Avastin: First Biologic Backed In EU For Resistant Ovarian Cancer 6/27/2014
Regeneron Pharmaceuticals, Inc. (REGN)'s Injection Eylea Recommended For Approval By CHMP 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
Eisai Company, Ltd. (ESALY.PK) Submits First Marketing Authorization Application For Anticancer Agent Lenvatinib In Japan 6/27/2014
Hyperion Therapeutics Announces European Medicines Agency Acceptance For Review Of Marketing Authorization Application For RAVICTI® 6/26/2014
BioSpecifics Technologies Corporation (BSTC) Announces Filing By Swedish Orphan Biovitrum For EU Approval Of XIAPEX For Peyronies Disease 6/26/2014
Auxilium Pharmaceuticals (AUXL) Release: Swedish Orphan AB Files For EU Approval Of Xiapex For Peyronies Disease 6/25/2014
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization In Italy For The Treatment Of Chronic Diabetic Macular Edema 6/23/2014
pSivida Corp (PSDV) Announces ILUVIEN® Receives Marketing Authorization In Italy For Treatment Of Chronic Diabetic Macular Edema 6/23/2014
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
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
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
EU Changes Its Tune On PTC Therapeutics, Inc. (PTCT) Drug, Shares Rocket 30.74% At Market Close (May 23, 2014) 5/27/2014
Eisai Company, Ltd. (ESALY.PK) Receives Positive Opinion From European Medicines Agency's CHMP On Expanding 5/27/2014
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
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
European Medicines Agency Recommends Approval Of Roche (RHHBY)'s Gazyvaro For Chronic Lymphocytic Leukaemia 5/23/2014
Despite Rejection, Teva Pharmaceutical Industries Limited (TEVA) And Active Biotech AB (BTPC) Remain Committed To The Development Of Multiple Sclerosis Nerventra® 5/23/2014
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
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
AbbVie (ABBV) Submits For EU Marketing Authorization Its Investigational, All-Oral, Interferon-Free Therapy For The Treatment Of Chronic Hepatitis C 5/8/2014
Theravance, Inc. (THRX) Release: Anoro® (Umeclidinium/Vilanterol) Gains Marketing Authorization in Europe For The Treatment Of COPD 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
RedHill Biopharma Ltd. (RDHL) Announces Positive European Scientific Advice Meeting Regarding RHB-102 And Plans To Submit A European Marketing Application 4/7/2014
Newron Pharmaceuticals (NWRN) Release: Safinamide Application For Authorization Submitted To Swissmedic 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
Medivir AB (MVRBF): Simeprevir Receives Positive CHMP Opinion For The Treatment Of Adults With Chronic Hepatitis C In The European Union 3/21/2014
Merck & Co., Inc. (MRK), Endocyte, Inc. (ECYT) Cancer Products Get Thumbs Up From EU Committee CHMP 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
Cubist Pharmaceuticals, Inc. (CBST) Announces European Medicines Agency Acceptance Of Tedizolid Marketing Authorization Application For Review 2/27/2014
European Medicines Agency Accepts Marketing Authorization Application For The Medicines Company (MDCO)'s Oritavancin 2/27/2014
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
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
GlaxoSmithKline (GSK)'s Anoro® (umeclidinium / vilanterol) Receives Positive Opinion From The CHMP In Europe For The Treatment Of COPD 2/20/2014