Baxter International, Inc. (BAX) Receives Marketing Authorization for HyQvia in European Union
5/21/2013
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Arena Pharmaceuticals, Inc. (ARNA) Withdraws Diet Drug Application in Europe
5/3/2013
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Omeros Corporation (OMER) Ophthalmology Product OMS302 Granted Eligibility for European Centralized Review
4/30/2013
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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
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Pfizer Inc. (PFE)'s Arthritis Drug Rejected by European Regulators
4/29/2013
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AVANIR Pharmaceuticals (AVNR) Receives Positive CHMP Opinion for Approval of NUEDEXTA in Europe
4/29/2013
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Astellas Pharma Inc. (YPH.BE), Medivation, Inc. (MDVN) Release: Positive CHMP Opinion for Xtandi ™ (Enzalutamide) in Advanced Prostate Cancer
4/26/2013
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VIVUS, Inc. (VVUS) Announces Positive Recommendation From CHMP Supporting Avanafil Approval in Europe
4/26/2013
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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
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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
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Curis, Inc. (CRIS) Announces Erivedge® Receives Positive CHMP Opinion for Conditional Approval in European Union
4/26/2013
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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
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Arena Pharmaceuticals, Inc. (ARNA) Announces Eisai Inc. (ESALF.PK)'s Submission of BELVIQ® (lorcaserin HCl) Marketing Authorization Application in Mexico
4/1/2013
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Pfizer Inc. (PFE)'s BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From the European Commission (EC)
3/28/2013
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European Medicines Agency Accepts MAA Submission of Shionogi, Inc.'s Ospemifene for the Treatment of VVA
3/27/2013
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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
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Biogen Idec, Inc. (Massachusetts) (BIIB) Multiple Sclerosis Drug Wins EU Agency's Backing
3/25/2013
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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
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Gentium S.p.A. Receives Negative Opinion From the CHMP on Defibrotide for the Treatment and Prevention of VOD
3/22/2013
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Sanofi (France) (SAN.PA) Gets EU Panel Backing for Multiple Sclerosis Pill Aubagio
3/22/2013
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Vanda Pharmaceuticals, Inc. (VNDA) Withdraws EU Filing for Schizophrenia Drug
3/15/2013
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Horizon Pharma, Inc. (HZNP) Receives Marketing Authorization for DUEXIS® From the United Kingdom Medicines and Healthcare Products Regulatory Agency
3/7/2013
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Takeda Pharmaceutical Co. Ltd. (TKPYY) Submits Marketing Authorisation Application for Vedolizumab in Moderately to Severely Active Ulcerative Colitis and Crohn's Disease in the European Union
3/7/2013
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BioTie Therapies Corp.: Selincro (nalmefene) Receives European Marketing Authorization
2/28/2013
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Taiho Pharmaceutical Submits Application for Approval to Manufacture and Market Novel Antitumor Agent TAS-102
2/27/2013
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Medivir AB (MVIRb.F): Regulatory Application Has Now Been Filed for Simeprevir (TMC435) in Japan for the Treatment of Genotype 1 Hepatitis C Patients
2/22/2013
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Alexza Pharmaceuticals, Inc. (ALXA) Receives Marketing Authorization for ADASUVE® (Staccato® Loxapine) in the European Union
2/21/2013
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Epigenomics AG Receives Notification of Priority Review Status and Acceptance for Filing by FDA of PMA Application for Epi proColon®
2/21/2013
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Gentium S.p.A. Negative on Defibrotide
2/21/2013
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UCB, Inc. (UCBJF.PK) Announces Regulatory Filings for Cimzia® (Certolizumab Pegol) to Treat Psoriatic Arthritis and Axial Spondyloarthritis
2/20/2013
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Sanofi (France) (SAN.PA) Expects FDA Decision on Lemtrada in H2 2013
1/30/2013
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Santhera Pharmaceuticals AG (SANN.SW) Plunges on European Eye Drug Rejection
1/21/2013
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European Medicines Agency Backs Pfizer Inc. (PFE) Leukemia Drug
1/21/2013
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Gentium S.p.A. Provides an Update on Defibrotide MAA to European Medicines Agency
1/17/2013
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GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) Announce Regulatory Submission for ANORO™ (UMEC/VI) in Europe
1/9/2013
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Otsuka Pharmaceutical Co., Ltd. and Lundbeck Inc. (LUN.CO) Initiate the Regulatory Process for Aripiprazole (Once-Monthly) Depot Formulation in Europe
12/27/2012
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Horizon Pharma, Inc. (HZNP) to Receive Approval of DUEXIS® From the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency
12/21/2012
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FINOX Biotech Release: r-FSH Biosimilar Submitted for European Medicines Agency Review
12/20/2012
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Shire plc (SHPG) ADHD Drug Elvanse Close to Europe Approval
12/19/2012
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Gentium S.p.A. Submit 2nd LoOIs Response to the European Medicines Agency's CHMP for Defibrotide MAA
12/18/2012
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Navidea Biopharmaceuticals (NEOP) Submits Lymphoseek Marketing Authorization Application to European Medicines Agency
12/18/2012
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Genzyme Corporation (GENZ)'s Mipomersen in Trouble in the Pipeline
12/17/2012
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H. Lundbeck A/S (LUN.CO) Receives Positive Opinion for Approval of Selincro (Nalmefene) in the European Union
12/14/2012
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Vanda Pharmaceuticals, Inc. (VNDA) Receives Negative Opinion From CHMP on Fanaptum™ for the Treatment of Schizophrenia
12/14/2012
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Alexza Pharmaceuticals, Inc. (ALXA) Release: the CHMP Delivers a Positive Opinion Recommending Grant of Marketing Authorization for ADASUVE® (Staccato® Loxapine) in the European Union
12/14/2012
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Halozyme Therapeutics, Inc. (HALO) Announced Roche (RHHBY) Filed a Marketing Authorization Application For Subcutaneous MabThera
12/10/2012
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Regeneron Pharmaceuticals, Inc. (REGN) Release: EYLEA® (aflibercept) Submitted for EU Marketing Authorization for the Treatment of Macular Edema Following Central Retinal Vein Occlusion
12/6/2012
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PTC Therapeutics, Inc. Announces European Medicines Agency Validation of Marketing Authorization Application for Ataluren in Duchenne Muscular Dystrophy
12/6/2012
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Novo Nordisk A/S (NVO): Ryzodeg® (insulin degludec/insulin aspart) Passed the Review by the First Committee on Drugs of Pharmaceutical Affairs in Japan
12/3/2012
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Merck & Co., Inc. (MRK) Withdraws MAA for Bone Cancer Treatment
11/30/2012
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Swedish Orphan Biovitrum Files to Expand Kineret® Label to Include CAPS
11/19/2012
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Alexza Pharmaceuticals, Inc. (ALXA) Receives Updated Day 180 List of Outstanding Issues for ADASUVE™ (Staccato® Loxapine) MAA
11/19/2012
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Zealand Pharma Announces That Once-Daily Lyxumia® 1 (lixisenatide) Has Received CHMP Positive Opinion for the Treatment of Adults With Type 2 Diabetes in the EU
11/16/2012
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Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (France) (SAN.PA) Release: ZALTRAP® (ziv-aflibercept) Receives CHMP Positive Opinion in the European Union for Previously Treated Metastatic Colorectal Cancer
11/16/2012
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Novartis AG (NVS) Bexsero Meningitis Shot Wins EU Agency's Backing
11/16/2012
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Skuldtech Identifies New Predictive Markers for Pancreatic Cancer Survival Resulting From Its Proprietary Technology Platform
11/6/2012
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Ferring Pharmaceuticals' European Marketing Authorization Application for Controlled Release Misoprostol Vaginal Delivery System for the Induction of Labor Accepted for Review
11/5/2012
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Seattle Genetics, Inc. (SGEN) Gets Conditional OK for ADCETRIS® in EU; Triggers $25 Million Milestone Payment From Millennium: The Takeda Oncology Company
10/31/2012
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Pfizer Inc. (PFE)’s XALKORI® Receives Conditional Marketing Authorization From the European Commission (EC) for the Treatment of Adults With Previously Treated ALK-Positive Advanced Non-Small Cell Lung Cancer in the EU
10/24/2012
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Acusphere Inc. (ACUS) Announces Submission of Marketing Authorisation Application for Imagify™ in Europe and Start of Procedural Review
10/24/2012
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VIVUS, Inc. (VVUS) Obesity Drug Gets Expected European Rejection
10/19/2012
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EU Follows US Nod for Eli Lilly and Company (LLY)'s Brain Plaque Test
10/19/2012
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AB Science (AB.PA) Confirms the Filing for the Marketing Authorization Application to the European Medicines Agency of Masitinib in the Treatment of Pancreatic Cancer
10/16/2012
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Gentium S.p.A. Receives Second List of Outstanding Issues From the European Medicines Agency's CHMP for Defibrotide MAA
10/10/2012
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Basilea Pharmaceutica (BSLN.SW)'s European Marketing Authorization Application for ceftobiprole for the Treatment of Pneumonia Accepted for Review
10/5/2012
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AB Science (AB.PA) Release: European Medicines Agency Accepts Marketing Application for Masitinib in the Treatment of Gleevec® Resistant Gastro-Intestinal Stromal Tumor
10/4/2012
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Gentium S.p.A. Provides Update on the Review of Defibrotide Marketing Authorization Application
9/26/2012
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EU Agency Backs Roche (RHHBY)'s Avastin for Ovarian Cancer
9/24/2012
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VIVUS, Inc. (VVUS) Shares Feel the Pain: Blockbuster Diet Drug Likely Won't be Sold in Europe
9/24/2012
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Eli Lilly and Company (LLY) Gets Positive CHMP Opinion for Cialis 5 Mg to Treat BPH
9/21/2012
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New Bayer HealthCare (BAY), Regeneron Pharmaceuticals, Inc. (REGN) Eye Drug Gets EU Agency Backing
9/21/2012
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Ironwood Pharmaceuticals Release: Linaclotide Receives Positive CHMP Opinion for the Treatment of IBS-C
9/21/2012
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Bristol-Myers Squibb Company (BMY) and Pfizer Inc. (PFE) Release: ELIQUIS® (apixaban) Receives CHMP Positive Opinion for the Prevention Of Stroke and Systemic Embolism in Patients With Nonvalvular Atrial Fibrillation
9/21/2012
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EU Body Backs Novartis AG (NVS)'s Galvus, Eucreas for Diabetes Indications
9/21/2012
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Lundbeck Inc. (LUN.CO) Files for Regulatory Approval of Vortioxetine
9/20/2012
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Boehringer Ingelheim Corporation Submits First Oncology Compound, afatinib* for European Approval
9/20/2012
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GlaxoSmithKline (GSK) Submits New Application for Synflorix in EU
9/18/2012
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Gentium S.p.A. to Present Oral Explanations to European Medicines Agency's CHMP for Defibrotide MAA
9/11/2012
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Janssen-Cilag International NV (JNJ) Submits European Marketing Authorisation Application for Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline
8/31/2012
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Ariad Pharmaceuticals, Inc. (ARIA) Announces Submission of Marketing Authorization Application for Ponatinib to the European Medicines Agency
8/30/2012
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Dynavax Technologies Corporation (DVAX) Marketing Authorization Application for HEPLISAV(TM) Accepted for Review by European Medicines Agency
8/22/2012
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Basilea Pharmaceutica (BSLN.SW) Submits European Marketing Authorization Application of Ceftobiprole for the Treatment of Pneumonia
7/30/2012
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Biovest International, Inc. Advances Process Seeking European Marketing Approval for BiovaxID™ Personalized Lymphoma Vaccine
7/30/2012
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Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization in Germany for the Treatment of Chronic Diabetic Macular Edema
7/27/2012
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pSivida Corp (PSDV) Announces Germany Grants ILUVIEN® Marketing Authorization for the Treatment of Chronic Diabetic Macular Edema
7/26/2012
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Dynavax Technologies Corporation (DVAX) Submits HEPLISAV™ for EU Marketing Authorization
7/24/2012
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Millennium: The Takeda Oncology Company and Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Announce Positive CHMP Opinion for Conditional Approval of ADCETRIS® (brentuximab vedotin) in Europe
7/20/2012
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Seattle Genetics, Inc. (SGEN) Announces ADCETRIS® Receives Positive CHMP Opinion for Conditional Approval in European Union
7/20/2012
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Celgene International Sárl (CELG) to Request Re-Examination of CHMP ISTODAX® (romidepsin) Opinion
7/20/2012
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Pfizer Inc. (PFE)’s Crizotinib Receives Positive Opinion for Conditional Marketing Authorization From the Committee for Medicinal Products for Human Use for the Treatment Of Adults With Previously Treated ALK-Positive Advanced Non-Small Cell Lung Cancer in the EU
7/20/2012
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First Gene Therapy in Western World From uniQure Receives Positive Opinion in Europe from CHMP
7/20/2012
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Astex Pharmaceuticals (ASTX) Release: DACOGEN® Receives a Positive Regulatory Recommendation in the European Union for Treatment of Acute Myeloid Leukemia
7/20/2012
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European Medicines Agency Accepts Pfizer Inc. (PFE)'s Bazedoxifene/Conjugated Estrogens MAA for Review
7/19/2012
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Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization in France for the Treatment of Chronic Diabetic Macular Edema
7/18/2012
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Teva Pharmaceutical Industries Limited (TEVA)/Active Biotech AB (BTPC) MS Pill Accepted for Review in Europe
7/17/2012
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GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) Announce Regulatory Submissions for FF/VI in the US and Europe
7/13/2012
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Arena Pharmaceuticals, Inc. (ARNA) Seeks Weight Control Drug Approval in Switzerland
7/12/2012
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Vitrolife: Application for Market Approval of STEEN Solution™ in the USA Has Been Submitted to the FDA
7/10/2012
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Acusphere Inc. (ACUS) Announces Completion of Marketing Authorisation Application for Imagify™ in Europe; Secures Additional Financing
7/9/2012
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Johnson & Johnson (JNJ) Pulls File to Extend Velcade's Use in EU
7/5/2012
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Medivation, Inc. (MDVN) Says Astellas Pharma Inc. (YPH.BE) Submits MAA to European Medicines Agency for Enzalutamide
6/27/2012
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Protalix Biotherapeutics, Inc. (PLX) to Review CHMP Opinion for ELELYSO(TM)
6/22/2012
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AMAG Pharmaceuticals, Inc. (AMAG) Release: Rienso® (Ferumoxytol) Receives European Marketing Authorization for the Treatment of Iron Deficiency Anemia in Adult Patients with Chronic Kidney Disease
6/22/2012
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Receives Positive CHMP Opinion for Teduglutide (Revestive®) for Patients with Short Bowel Syndrome
6/22/2012
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European Medicines Agency Gives First Opinion for Sanofi Pasteur (SASY.PA)'s Vaccine for Use Outside the EU
6/22/2012
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Novartis AG (NVS), AstraZeneca PLC (AZN) Win EU Drug Okays; Pfizer Inc. (PFE) Loses Out
6/22/2012
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Gentium S.p.A. Submits Day 180 Response to List of Outstanding Issues Received From the EMA's CHMP for Defibrotide MAA
6/21/2012
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Furiex Pharmaceuticals, Inc. (FURX) Confirms Takeda Global Research & Development Center, Inc.'s Announcement on the Acceptance of the EMA Submissions for Two Fixed-Dose Alogliptin Combination Therapies for the Treatment of Type 2 Diabetes
6/19/2012
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European Medicines Agency Validates Gilead Sciences, Inc. (GILD)'s Marketing Application for Elvitegravir for Treatment of HIV Infection
6/19/2012
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Johnson & Johnson (JNJ)'s) Janssen-Cilag International NV (JNJ) Submits Additional Marketing Application for ZYTIGA
6/15/2012
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Sanofi (France) (SAN.PA) Seeks Approval for Diabetes Drug in Japan
6/11/2012
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pSivida Corp (PSDV) Announces Portugal Grants ILUVIEN® Marketing Authorization for the Treatment of Chronic Diabetic Macular Edema
6/5/2012
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Alimera Sciences (ALIM)' ILUVIEN(R) Receives Marketing Authorization in Portugal for the Treatment of Chronic Diabetic Macular Edema
6/5/2012
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VIVUS, Inc. (VVUS) Provides Update on Timing of European Decision for Qnexa(R)
6/5/2012
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Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Submits US and European Regulatory Applications for use of PROMACTA/REVOLADE to Increase Platelet Counts in Patients with Hepatitis C
5/30/2012
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Eisai Inc. (ESALF.PK) Receives Positive CHMP Opinion for Fycompa
5/29/2012
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Pfizer Inc. (PFE)’s Axitinib Receives Positive Opinion from the Committee for Human Medicinal Products for the Second-line Treatment of Advanced Kidney Cancer in the EU
5/25/2012
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Vertex Pharmaceuticals (MA) (VRTX) Receives European CHMP Positive Opinion for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis
5/25/2012
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Boehringer Ingelheim Corporation and Eli Lilly and Company (LLY) Release: Jentadueto™ (Linagliptin/Metformin Hydrochloride) Tablets Recommended for Approval in the Treatment of Adults with Type 2 Diabetes in Europe
5/25/2012
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Gilead Sciences, Inc. (GILD) European Marketing Application for Boosting Agent Cobicistat
5/24/2012
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Biovest International, Inc. to Seek Marketing Approval in the EU for BiovaxID® Personalized Lymphoma Cancer Vaccine
5/14/2012
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Cell Therapeutics, Inc. (CTIC)' Pixuvri® Approved in European Union as Monotherapy to Treat Adult Patients With Multiply Relapsed or Refractory Aggressive Non-Hodgkin B-Cell Lymphomas
5/11/2012
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Nuvo Research Inc. (NRI.TO)'s Pliaglis Receives Positive Opinion from the BfArM in the E.U.
5/7/2012
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pSivida Corp (PSDV) Announces United Kingdom Grants ILUVIEN® Marketing Authorization for the Treatment of Chronic Diabetic Macular Edema
5/7/2012
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Curis, Inc. (CRIS) Announces Collaborator Roche (RHHBY)'s Submission of Erivedge(TM) for Registration With Australian Regulatory Authority
5/7/2012
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Gentium S.p.A. Receives Day 180 List of Outstanding Issues From the CHMP for Defibrotide MAA
5/4/2012
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Alimera Sciences (ALIM) Release: ILUVIEN(R) Receives Marketing Authorization in Austria for the Treatment of Chronic Diabetic Macular Edema
4/24/2012
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AMAG Pharmaceuticals, Inc. (AMAG) Gets Initial EU Nod, Potentially Bagging a $30 Million Milestone Payment From Takeda Pharmaceutical Co. Ltd. (TKDG.DE)
4/23/2012
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Amsterdam Molecular Therapeutics (AMT) (RHP.DE) Receives Further Opinion on Glybera® Marketing Authorization Application
4/23/2012
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AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Say FORXIGA Gets Positive CHMP Opinion in EU
4/23/2012
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Allos Therapeutics, Inc. (ALTH) Announces Outcome of Request for Re-examination of CHMP Opinion for FOLOTYN® in Europe
4/20/2012
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Incyte Corporation (INCY) Announces EU Regulatory Milestone for Ruxolitinib; Triggering a $40 Million Milestone Payment From Novartis AG (NVS)
4/20/2012
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Arena Pharmaceuticals, Inc. (ARNA) Announces European Medicines Agency's Acceptance of Lorcaserin Marketing Authorization Application for Weight Control
3/27/2012
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VIVUS, Inc. (VVUS) Announces Acceptance of Avanafil Application in Europe
3/26/2012
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Raptor Pharmaceutical Inc. (RPTP) Announces EMA Validation of Marketing Authorization Application for RP103 for the Treatment of Nephropathic Cystinosis
3/26/2012
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Aegerion Pharmaceuticals, Inc. Announces EMA Acceptance for Review of Marketing Authorization Application for Lomitapide
3/20/2012
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Endocyte, Inc. (ECYT) to Submit EU Conditional Marketing Authorization Applications for EC145 and EC20
3/14/2012
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Arena Pharmaceuticals, Inc. (ARNA) Files European Marketing Authorization Application for Lorcaserin for Weight Control
3/6/2012
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Repligen Corporation (RGEN) Announces Submission of Marketing Authorization Application in EU for SecreFlo™ to Improve Pancreatic Imaging in Patients with Pancreatitis
3/5/2012
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Baxter International, Inc. (BAX) Receives Marketing Authorization in European Union for VEPACEL Pre-Pandemic Influenza Vaccine
3/2/2012
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Genzyme Corporation (GENZ) Announces European Medicines Evaluation Agency Accepts Oral Teriflunomide Marketing Application for Treatment of Multiple Sclerosis
2/23/2012
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Gentium S.p.A. Responds to the EMA's Day 120 List of Questions for Defibrotide MAA
2/21/2012
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Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) Say CHMP Recommends Approval of BYETTA for Use With Basal Insulin
2/21/2012
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Cell Therapeutics, Inc. (CTIC) Release: European Medicines Evaluation Agency Committee for Medicinal Products for Human Use Issues Positive Opinion for Conditional Approval on Marketing Authorization Application for Pixuvri™
2/17/2012
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Horizon Pharma, Inc. Modifies DUEXIS(R) Marketing Authorization Application to Include Recently Approved Manufacturing Site
2/13/2012
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Alexza Pharmaceuticals, Inc. (ALXA) Receives Day 80 Assessment Report for ADASUVE (Staccato(R) Loxapine) MAA
2/13/2012
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Clinuvel Files European Marketing Authorisation Application for SCENESSE® (afamelanotide)
2/6/2012
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Navidea Biopharmaceuticals (NEOP) Obtains Positive European Medicines Evaluation Agency Guidance for Lymphoseek® (Tilmanocept); Company to Submit Marketing Authorization Application in Europe
2/2/2012
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Amsterdam Molecular Therapeutics (AMT) (RHP.DE) Announces European Commission (EC) Delays Decision on Glybera® Marketing Authorisation and Requests Further Information From the CHMP
1/30/2012
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Cell Therapeutics, Inc. (CTIC) Expects That the European Medicines Evaluation Agency Committee for Medicinal Products for Human Use (CHMP) May Issue an Opinion on the Marketing Authorization Application ("MAA") on Pixuvri(TM) in Mid-February
1/20/2012
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Shire plc's Venvanse(R) (Lisdexamfetamine Dimesylate) Marketing Application Accepted for Review in Europe
1/5/2012
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Basilea Pharmaceutica (BSLN.SW) to File Application for Marketing Authorization of Ceftobiprole for the Treatment of Pneumonia
1/5/2012
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Gentium S.p.A. Provides Update on MAA Process for Defibrotide in Europe
12/29/2011
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Curis, Inc. (CRIS) Announces Collaborator Roche (RHHBY)’s Submission of Marketing Authorization Application for Vismodegib in Advanced Basal Cell Carcinoma
12/22/2011
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BioTie Therapies Corp.'s Partner Lundbeck Inc. Submits European Marketing Authorization Application for Selincro(TM) (nalmefene)
12/21/2011
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Gilead Sciences, Inc. (GILD) Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection
12/21/2011
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Optimer Pharmaceuticals, Inc. (OPTR) Release: The European Commission (EC) Grants Marketing Authorization for DIFICLIR(TM) (fidaxomicin) Tablets for Treatment of Clostridium difficile Infections
12/14/2011
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Cell Therapeutics, Inc. (CTIC) European Medicines Evaluation Agency's (EMA) Committee for Human Medicinal Products (CHMP)Tentatively Scheduled to Render an Opinion on PixuvriTM Marketing Authorization Application on January 19, 2012
12/5/2011
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Alexion Pharmaceuticals Inc. (ALXN)'s Soliris® (eculizumab) Granted Marketing Authorization in Europe for Treatment of Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
11/29/2011
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Gilead Sciences, Inc. (GILD) Receives European Marketing Authorization for Eviplera®, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults
11/28/2011
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Allergy Therapeutics plc Release: Submissions of Complete Response to PEI in Germany and Clinical Study Protocol to US FDA
11/28/2011
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Pfizer Inc. (PFE) Announces European Medicines Evaluation Agency Acceptance of Regulatory Submission For Tofacitinib For the Treatment of Rheumatoid Arthritis
11/21/2011
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EU Regulators Back AstraZeneca PLC (AZN) Thyroid Cancer Drug
11/18/2011
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AVANIR Pharmaceuticals (AVNR) Announces European Medicines Evaluation Agency Acceptance of Marketing Authorization Application for NUEDEXTA
11/17/2011
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BioDelivery Sciences International (BDSI) Release: BEMA Fentanyl Submitted for Marketing Authorization in Taiwan
11/7/2011
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Zealand Pharma Announces That a European Regulatory Application Has Been Submitted for Lyxumia(R) (Lixisenatide) by Its Partner Sanofi (France) (SASY.PA), as a Novel Once-Daily GLP-1 Agonist for Type-2 Diabetes
11/3/2011
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AVANIR Pharmaceuticals (AVNR) Submits European Marketing Authorization Application for NUEDEXTA
10/31/2011
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Alexza Pharmaceuticals, Inc. (ALXA) Announces Submission of European Marketing Authorization Application for Adasuve(R) (Staccato(R) Loxapine)
10/27/2011
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Pharmaxis Ltd (PXS.AX) Announces Major Milestone: Positive Bronchitol Opinion for Europe
10/24/2011
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Amsterdam Molecular Therapeutics (AMT) (RHP.DE) Receives Opinion on Re-examination of Glybera(R) Marketing Authorisation Application
10/21/2011
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Gentium S.p.A. Provides Update on MAA Process for Defibrotide in Europe
10/20/2011
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ThromboGenics NV Announces EMA Acceptance for Review of Marketing Authorisation Application for Ocriplasmin
10/19/2011
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Inspiration Biopharmaceuticals Announces Acceptance of European Marketing Authorization Application for IB1001 for the Treatment of Hemophilia B
10/3/2011
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Ipsen's Partner, Inspiration Biopharmaceuticals, Announces Acceptance of European Marketing Authorization Application for IB1001 for the Treatment of Hemophilia B and Will Receive $35 Million
10/3/2011
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Baxter International, Inc. (BAX) Submits European Marketing Authorization Application for HyQ, an Investigational IG Therapy for Primary Immunodeficiencies
9/30/2011
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Ironwood Pharmaceuticals Partner Almirall Announces Linaclotide European Regulatory Submission for the Treatment of Irritable Bowel Syndrome with Constipation
9/29/2011
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Novartis AG (NVS) Seeks Approval for New Smoker's Cough Drug
9/28/2011
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European CHMP Adopts Positive Opinion for Gilead Sciences, Inc. (GILD)'s Eviplera(R), a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection
9/23/2011
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Astellas Pharma Inc. (YPH.BE) and Theravance, Inc. (THRX) Announce European Marketing Authorization for VIBATIV(R) for Nosocomial Pneumonia Caused by MRSA
9/16/2011
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ViroPharma Incorporated (VPHM)'s Buccolam(R) (Midazolam, Oromucosal Solution) Granted European Marketing Authorization for Treatment of Acute Seizures
9/8/2011
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Astellas Pharma Inc. (YPH.BE) Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe
8/29/2011
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Cell Therapeutics, Inc. (CTIC) Submits Day 120 Response for Pixantrone Marketing Authorization Application to European Medicines Evaluation Agency; Potential Q1 2012 Opinion on Approval
8/23/2011
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Apricus Biosciences (APRI) to File for Market Authorization to Sell Vitaros(R) for Erectile Dysfunction in Latin America
8/9/2011
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Apricus Biosciences (APRI) to File for Market Authorization to Sell Vitaros(R) for Erectile Dysfunction in Latin America
8/8/2011
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Teva Pharmaceutical Industries Limited (TEVA) Receives European Marketing Authorization for ZOELY(TM) Oral Contraceptive
8/2/2011
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Ariad Pharmaceuticals, Inc. (ARIA) Announces That Its Partner, Merck & Co., Inc. (MRK), Has Submitted for Approval of Ridaforolimus, an Investigational mTOR Inhibitor, in the European Union
8/1/2011
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Genzyme Corporation (GENZ) and Isis Pharmaceuticals, Inc. (ISIS) Announce Submission of European Marketing Authorization Application for Mipomersen (Kynamro(R))
7/28/2011
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AVANIR Pharmaceuticals (AVNR) Provides Update on European Regulatory Filing for NUEDEXTA
7/26/2011
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European Medicines Agency Accepts Vanda Pharmaceuticals, Inc. (VNDA)'s Marketing Authorization Application For Oral Iloperidone Tablets
7/25/2011
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Apricus Biosciences (APRI) Files Marketing Application for Vitaros(R) as a Treatment for Erectile Dysfunction in Switzerland
7/19/2011
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Amgen (AMGN) Release: XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
7/15/2011
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Amgen (AMGN) Release: XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
7/14/2011
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Amsterdam Molecular Therapeutics (AMT) (RHP.DE) Files Glybera® European Marketing Application
7/8/2011
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Nuvo Research Inc. (NRI.TO) Announces Marketing Authorization Application For PLIAGLIS® Validated By European Regulatory Agencies
7/6/2011
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Regeneron Pharmaceuticals, Inc. (REGN) and Bayer HealthCare (BAY) Release: EYLEA™ (aflibercept injection) Submitted in Japan for Marketing Authorization for the Treatment of Wet Age-Related Macular Degeneration
6/29/2011
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Apricus Biosciences (APRI)' Marketing Application for Vitaros(R), for the Treatment of Erectile Dysfunction, is Accepted for Review in Europe
6/28/2011
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ViroPharma Incorporated (VPHM) Announces Positive CHMP Opinion for Buccolam® (Midazolam, Oromucosal Solution) in the European Union
6/24/2011
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MEDA: Zyclara Filed in Europe
6/23/2011
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Clinical Development Plan for Pediatric Use of PROLOR Biotech (PBTH)'s Long-Acting Human Growth Hormone has Been Accepted for Review by European Medicines Agency
6/20/2011
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ViroPharma Incorporated (VPHM)'s Cinryze® (C1 Inhibitor [Human]) Granted European Marketing Authorization for Hereditary Angioedema (HAE)
6/15/2011
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