BioSpace.com News

Cell Therapeutics, Inc. Release: New EXTEND Analyses Evaluate Efficacy of Single Agent PIXUVRI® in 3rd and 4th Line Salvage Setting With and Without Prior Rituximab Treatment

Mon, 17 Jun 2013 12:00:00 AM GMT

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SEATTLE, June 17, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced results...

Orexo AB Release: First Patient Dosed in New Phase III Study Targeted Towards a Future Clinical Indication Expansion for Zubsolv

Mon, 17 Jun 2013 12:00:00 AM GMT

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Uppsala, Sweden June 17, 2013 - Orexo AB announces today that the firstpatient has been dosed with Zubsolv in a phase III study for a new clinicalindication for Zubsolv.

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NPS Pharmaceuticals, Inc. Release: Initial Findings from PARADOX, Largest and Most Comprehensive Research Analyzing the Burden of Hypoparathyroidism, Reveals Collection of Nearly 40 Physical, Cognitive, Emotional Symptoms

Mon, 17 Jun 2013 12:00:00 AM GMT

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BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide...

Orexo AB: First Patient Dosed in New Phase III Study Targeted Towards a Future Clinical Indication Expansion for Zubsolv

Mon, 17 Jun 2013 12:00:00 AM GMT

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UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Orexo AB (STO:ORX) announces today that the first patient has been dosed with Zubsolv in a phase III study for a new clinical indication for Zubsolv. Currently...

MannKind Corporation Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes

Mon, 17 Jun 2013 12:00:00 AM GMT

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VALENCIA, Calif.--(BUSINESS WIRE)--MannKind Corporation (Nasdaq: MNKD) today announced that all follow-up visits have been completed for the patients enrolled in Study 175, a Phase 3 clinical study of AFREZZA...

Incyte Corporation Drug Jakafi® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients With Myelofibrosis

Mon, 17 Jun 2013 12:00:00 AM GMT

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STOCKHOLM--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today announced results from two ongoing clinical trials of Jakafi (ruxolitinib), an oral JAK1 and JAK2 inhibitor that is FDA-approved for the treatment...

These Mutated Cystic Fibrosis Cells are Worth Billions to Vertex Pharmaceuticals (MA)

Fri, 14 Jun 2013 12:00:00 AM GMT

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This is my favorite data slide from Vertex Pharmaceuticals' (VRTX_) presentation at the European Cystic Fibrosis Society meeting. The slide is important because it helps explain how Vertex will dominate cystic...

Amgen Shows Off Phase 3 Ovarian Cancer Data

Fri, 14 Jun 2013 12:00:00 AM GMT

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Amgen Announces Top-Line Results Of Phase 3 Trebananib (AMG 386) TRINOVA-1 Trial In Recurrent Ovarian Cancer

THOUSAND OAKS, Calif., June...

Boehringer Ingelheim Corporation Release: New Long-Term Data Published in /i> Reinforce Safety Profile of Pradaxa® (dabigatran etexilate mesylate)

Fri, 14 Jun 2013 12:00:00 AM GMT

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RIDGEFIELD, Conn., June 14, 2013 /PRNewswire/ --Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from...

Immunomedics, Inc. Presents Epratuzumab's Mechanism of Action in Systemic Lupus Erythematosus

Thu, 13 Jun 2013 12:00:00 AM GMT

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MADRID, Spain, June 13, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq: IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment...

Data and Safety Monitoring Board Recommends Continuation of Sunesis Pharmaceuticals, Inc.' VALOR Trial With No Change to Study Conduct

Thu, 13 Jun 2013 12:00:00 AM GMT

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SOUTH SAN FRANCISCO, Calif., June 13, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the independent Data and Safety Monitoring Board (DSMB) for the VALOR trial has...

Janssen Research & Development Release: STELARA® Phase 3 Study Published in the Lancet Reports One Year Efficacy and Safety in Treatment of Active Psoriatic Arthritis

Thu, 13 Jun 2013 12:00:00 AM GMT

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SPRING HOUSE, Pa., June 13, 2013 /PRNewswire/ -- Results from a Janssen Research & Development, LLC (Janssen)-sponsored...

Intarcia Therapeutics, Inc. Supports American Diabetes Association Call For Independent Review Of Incretin-Based Therapies

Thu, 13 Jun 2013 12:00:00 AM GMT

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BOSTON, June 13, 2013 /PRNewswire/ -- Intarcia Therapeutics, Inc...

Ferrer Internacional Successfully Completes a Phase III Clinical Trial in Adult and Paediatric Patients With Impetigo for Novel Antibacterial Compound Ozenoxacin

Wed, 12 Jun 2013 12:00:00 AM GMT

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Barcelona, Spain, June 5, 2013 - Ferrer, a privately-held Spanish pharmaceutical company with full vertical integration from R&D to distribution, announces today that it has successfully completed a phase III...

Trius Therapeutics Announces Publication of Antibiotic Safety Study in /i>

Wed, 12 Jun 2013 12:00:00 AM GMT

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SAN DIEGO, June 12, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of antibiotics for serious infections...

Celgene International S??rl Release: Signs and Symptoms of Psoriatic Arthritis Significantly Improved in Patients Receiving Long-Term Oral Apremilast Treatment in Phase III Study (PALACE-1)

Wed, 12 Jun 2013 12:00:00 AM GMT

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BOUDRY, Switzerland (June 12, 2013) Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced 52-week results from PALACE 1, the Companys first phase III...

Janssen Biotech Inc. Release: Five-Year SIMPONI Data Reported In Treatment of Signs and Symptoms of Moderately to Severely Active Rheumatoid Arthritis

Wed, 12 Jun 2013 12:00:00 AM GMT

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MADRID, June 12, 2013 /PRNewswire/ --Janssen Biotech, Inc. announced today new five-year data from three pivotal Phase...

Argos Therapeutics, Inc. Announces US and Global Expansion for Ongoing Pivotal Phase 3 ADAPT Study for Personalized Immunotherapy

Tue, 11 Jun 2013 12:00:00 AM GMT

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DURHAM, N.C., June 10, 2013 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of...

Navidea Biopharmaceuticals Announces Results From Lymphoseek® Study on Accuracy of Lymph Node Detection From Injection Time to Surgery

Tue, 11 Jun 2013 12:00:00 AM GMT

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DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced positive results from a meta...

Cerus Corporation Initiates Patient Enrollment in European Phase III Clinical Trials for INTERCEPT Red Blood Cells for Acute and Chronic Anemia

Tue, 11 Jun 2013 12:00:00 AM GMT

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CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that it has initiated patient enrollment in two European Phase III clinical trials for the INTERCEPT System for red blood cells...

rEVO Biologics, an LFB Company, Announces Completion of a Dose Ranging Study of a Novel, Recombinant Form of Factor VIIa in Patients With Hemophilia A and B

Tue, 11 Jun 2013 12:00:00 AM GMT

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FRAMINGHAM, Mass.--(BUSINESS WIRE)--rEVO Biologics, an LFB Company, announced today that it has completed the treatment and follow up phase of a key dose ranging study of LR769, a novel recombinant form of human...

Boehringer Ingelheim Corporation's Investigational Faldaprevir+ Achieved Viral Cure in 88% of Treatment-Naive Hepatitis C Patients in Asia

Mon, 10 Jun 2013 12:00:00 AM GMT

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INGELHEIM, Germany--(BUSINESS WIRE)--New findings presented today during the APASL Liver Week in Singapore, highlighted the efficacy and safety of faldaprevir plus pegylated interferon and ribavirin (PegIFN...

Adamas Pharmaceuticals to Report Positive Phase 2/3 Results For ADS-5102 for the Treatment of Levodopa-Induced Dyskinesia in Parkinson's Disease

Mon, 10 Jun 2013 12:00:00 AM GMT

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EMERYVILLE, Calif., June 10, 2013 /PRNewswire/ -- Adamas Pharmaceuticals, Inc. announced today that the...

Argos Therapeutics, Inc. Announces U.S. and Global Expansion for Ongoing Pivotal Phase 3 ADAPT Study for Personalized Immunotherapy

Mon, 10 Jun 2013 12:00:00 AM GMT

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DURHAM, N.C. June 10, 2013 Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious...

AMAG Pharmaceuticals, Inc. Announces Submission of a Type II Variation for Rienso Label Expansion in Europe to Include All Adult Iron Deficiency Anemia Patients Who Cannot Take Oral Iron

Fri, 07 Jun 2013 12:00:00 AM GMT

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LEXINGTON, Mass., June 7, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that its European commercial partner, Takeda Pharmaceutical Company Limited, has submitted a type...

Puma Biotechnology Initiates Phase III Trial of PB272 (Neratinib) in HER2-Positive Metastatic Breast Cancer Patients

Fri, 07 Jun 2013 12:00:00 AM GMT

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LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE:PBYI), a development stage biopharmaceutical company, announced the initiation of its Phase III clinical trial of the Company's lead drug candidate...

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. Say VEGF Trap-Eye Shows Promise as mCNV Treatment

Thu, 06 Jun 2013 12:00:00 AM GMT

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Regeneron and Bayer Report Positive Phase 3 Results for EYLEA (aflibercept) Injection in Myopic Choroidal Neovascularization (mCNV)

TARRYTOWN, N.Y.,

AstraZeneca PLC Scraps Rigel Pharmaceuticals, Inc. Arthritis Pill in New R&D Blow, to Write Off $140 Million Charge

Thu, 06 Jun 2013 12:00:00 AM GMT

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AstraZeneca announces top-line results from Phase III OSKIRA Trials of FOSTAMATINIB and decision not to proceed with regulatory filings

June 04, 2013 -- Rights to the...

Medivir AB Release: Primary Efficacy and Safety Data From Four Phase III Japanese Studies of Simeprevir Presented at

Thu, 06 Jun 2013 12:00:00 AM GMT

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Stockholm, Sweden Medivir AB (OMX: MVIR) reports that its partner JanssenPharmaceutical R&D Ireland (Janssen) today announced primary efficacy and safetyresults from four Japanese phase III clinical studies...

Vanda Pharmaceuticals, Inc. Presents Data From Tasimelteon Phase III Studies in Non-24-Hour Disorder

Thu, 06 Jun 2013 12:00:00 AM GMT

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WASHINGTON, June 5, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) presented additional entrainment...

ARCA biopharma Release: Gencaro™ Potential Efficacy in Preventing Atrial Fibrillation Paper Published in /i>: Heart Failure

Thu, 06 Jun 2013 12:00:00 AM GMT

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BROOMFIELD, Colo.--(BUSINESS WIRE)--ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the paper Prevention...

Receptos Provides Update on Progress of Lead Product Candidate RPC1063

Wed, 05 Jun 2013 12:00:00 AM GMT

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SAN DIEGO, June 5, 2013 (GLOBE NEWSWIRE) -- Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, confirmed today that...

BioMarin Pharmaceutical Inc. Initiates Phase 3 Trial for PEG-PAL for the Treatment of PKU

Wed, 05 Jun 2013 12:00:00 AM GMT

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SAN RAFAEL, Calif., June 5, 2013 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has initiated the Phase 3 program for PEG-PAL (PEGylated recombinant Phenylalanine Ammonia...

Eli Lilly and Company Says Superiority Study of Alimta for Lung Cancer Fails to Meet Goals

Tue, 04 Jun 2013 12:00:00 AM GMT

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PRONOUNCE Study Does Not Achieve Primary Superiority Endpoint for ALIMTA (Pemetrexed for Injection), Similar PFS and OS Results Were Observed Between the Two Drug and the Three Drug Regimens...

Hospira, Inc. Data on European Biosimilar Epoetin, Retacrit, Affirm Treatment Response, Tolerability in Management of Anemia Secondary to Chemotherapy

Tue, 04 Jun 2013 12:00:00 AM GMT
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LAKE FOREST, Ill., June 3, 2013 /PRNewswire/ -- Hospira, Inc.<...

PROLOR Biotech Initiates Pivotal Phase III Trial Of Its Longer-Acting Version Of Human Growth Hormone

Tue, 04 Jun 2013 12:00:00 AM GMT
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NES-ZIONA, Israel, June 4, 2013 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Mkt: PBTH), a company developing next...

CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A

Tue, 04 Jun 2013 12:00:00 AM GMT
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KING OF PRUSSIA, Pa., June 4, 2013 /PRNewswire/ -- CSL...

Genentech's Avastin Fails Studies in New Brain Tumor Patients

Mon, 03 Jun 2013 12:00:00 AM GMT
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Genentech Announces Final Phase III Study Results of Avastin Plus Radiotherapy and Chemotherapy in People with an Aggressive Form of Brain Cancer

CHICAGO--(BUSINESS WIRE...

Amgen Melanoma Drug Improved Survival by 21 Pct in Interim Look

Mon, 03 Jun 2013 12:00:00 AM GMT
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Amgen Presents Positive Results From Talimogene Laherparepvec Phase 3 Study In Patients With Metastatic Melanoma

THOUSAND OAKS, Calif.,

Novartis AG Says BOLERO-3 Trial Meets Primary Endpoint

Mon, 03 Jun 2013 12:00:00 AM GMT
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Novartis pivotal Phase III trial shows Afinitor significantly delays tumor growth in women with HER2 positive advanced breast cancer

EAST HANOVER, N.J.,

AstraZeneca PLC Advances PARP Inhibitor Into Phase 3 Trial With BRACAnalysis®

Mon, 03 Jun 2013 12:00:00 AM GMT
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SALT LAKE CITY, June 1, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that AstraZeneca will use Myriad's BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca...

Boehringer Ingelheim Corporation Release: LUME-Lung 1: Nintedanib* Plus Chemotherapy Extends the Life of Lung Cancer Patients With Adenocarcinoma

Mon, 03 Jun 2013 12:00:00 AM GMT
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INGELHEIM, Germany--(BUSINESS WIRE)--The LUME-Lung 1 Phase III clinical trial results showed that the novel investigational compound nintedanib*, an oral triple angiokinase inhibitor, extended life by 2.3 months...

Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc.'s Liver Cancer Drug Nexavar Slows Rare Thyroid Tumor

Mon, 03 Jun 2013 12:00:00 AM GMT
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Phase 3 DECISION Trial Investigating the Use of Nexavar (sorafenib) Demonstrated Significant Improvement in Progression-Free Survival in Patients with Radioactive Iodine-Refractory Differentiated...

MannKind Corporation Completes Phase 3 Clinical Study of AFREZZA in Patients With Type 1 Diabetes

Mon, 03 Jun 2013 12:00:00 AM GMT
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VALENCIA, Calif.--(BUSINESS WIRE)--MannKind Corporation (Nasdaq: MNKD) today announced that all follow-up visits have been completed for the patients enrolled in Study 171, a Phase 3 clinical study of AFREZZA...

Ampio Pharmaceuticals, Inc. Provides Clinical Updates

Mon, 03 Jun 2013 12:00:00 AM GMT
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GREENWOOD VILLAGE, Colo., June 3, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) today announced...

Takeda Pharmaceutical Co. Ltd. Release: American Society of Clinical Oncology Presentation Highlights Results of Single Agent oral MLN9708 in Heavily Pretreated Patients with Relapsed and/or Refractory Multiple Myeloma

Mon, 03 Jun 2013 12:00:00 AM GMT
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CHICAGO & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) today reported results from a Phase 1 study evaluating the safety, tolerability, and maximum tolerated dose (MTD) of...

Celgene International S??rl Release: Analyses of MPACT Trial Evaluating ABRAXANE?? Combination Therapy for the Treatment of Advanced Pancreatic Cancer Presented at American Society of Clinical Oncology 2013

Mon, 03 Jun 2013 12:00:00 AM GMT
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BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced several analyses of a phase III clinical trial of ABRAXANE (paclitaxel protein...

KAEL???GemVax Release: Final Results From the Phase III TeloVac Trial in Pancreatic Cancer Presented at American Society of Clinical Oncology, Chicago, June 3rd 2013.

Mon, 03 Jun 2013 12:00:00 AM GMT
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CHICAGO, Ill.--(BUSINESS WIRE)--The final results from TeloVac, a multi-centre Phase III trial of the GV1001 vaccine in advanced and metastatic pancreatic cancer were presented today at the annual ASCO meeting...

Celgene International S??rl Release: Updated Studies Evaluating POMALYST® (pomalidomide) In Previously Treated Multiple Myeloma Patients Presented at American Society of Clinical Oncology

Mon, 03 Jun 2013 12:00:00 AM GMT
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BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced updated data from MM-003, the Companys phase III international...

Janssen Therapeutics Release: Survey of Participants from Landmark GRACE Trial Provides Patients' Perspectives From an HIV Clinical Study

Fri, 31 May 2013 12:00:00 AM GMT
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TITUSVILLE, N.J., May 30, 2013 /PRNewswire/ -- A survey of a segment of clinical trial participants from the GRACE...

FDA Designates Alexion Pharmaceuticals Inc.'s Product for Rare Disease as "Breakthrough Therapy"

Thu, 30 May 2013 12:00:00 AM GMT
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LAUSANNE, Switzerland--(BUSINESS WIRE)--Alexion Pharma International Srl, a subsidiary of Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), today announced that the U...

GlaxoSmithKline, Genmab A/S Say Combo Boosts PFS in P3 Leukemia Study

Thu, 30 May 2013 12:00:00 AM GMT
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GSK and Genmab Announce Positive Top-Line Results From Pivotal Study of ARZERRA(R) (ofatumumab) Combined With Chlorambucil in Previously Untreated Chronic Lymphocytic Leukemia...

Beijing Vigoo Biological Says EV71 Vaccine Passes Phase III Test

Thu, 30 May 2013 12:00:00 AM GMT
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by Richard Daverman, PhD
May 29, 2013 -- Beijing Vigoo Biological, a vaccine-focused subsidiary of China National Biotec Group, reported that its Enterovirus 71 vaccine was effective in up to 90% of...

Sunesis Pharmaceuticals, Inc. Release: Vosaroxin Review Published in /i>

Thu, 30 May 2013 12:00:00 AM GMT
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SOUTH SAN FRANCISCO, Calif., May 30, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the publication of a peer-reviewed paper in Expert Opinion on Pharmacotherapy featuring...

Amarin Corporation PLC Announces Additional Effects of Vascepa® on Lipoprotein Particle Concentration From the ANCHOR Study Presented at the Annual Scientific Sessions

Thu, 30 May 2013 12:00:00 AM GMT
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BEDMINSTER, N.J. and DUBLIN, Ireland, May 30, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve...

NeuroVive Pharmaceutical AB: European Phase III Study Approaches Its Final Stage

Wed, 29 May 2013 12:00:00 AM GMT
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NeuroVive Pharmaceutical AB (publ), a leading mitochondrial medicine company,announces that the ongoing international multicenter phase III study on thecompanys drug candidate CicloMulsion (the CIRCUS...

Novo Nordisk A/S Says Obesity Drug Trial Confirms Weight Loss

Tue, 28 May 2013 12:00:00 AM GMT
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BAGSVAERD, Denmark I 23 May 2013 I Novo Nordisk today announced the headline results from a 56-week double-blind phase 3a clinical trial investigating the potential of liraglutide to induce and maintain weight...

SALVAT Completes Enrollment of Phase III Study for a New Combination in Acute Otitis Media in Pediatric Patients With Tympanostomy Tubes (AOMT)

Tue, 28 May 2013 12:00:00 AM GMT
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BARCELONA, Spain--(BUSINESS WIRE)--SALVAT announced that clinical trial enrollment has completed for the Phase III study evaluating the efficacy and safety of a new otic solution containing Ciprofloxacin and...

Zensun Announces Positive Clinical Results for Neucardin™ to Improve Heart Function and Reduce Mortality in Chronic Heart Failure Patients

Thu, 23 May 2013 12:00:00 AM GMT
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SAN DIEGO and SHANGHAI, May 23, 2013 /PRNewswire/ -- Zensun Sci & Tech, Ltd., a...

TauRx Therapeutics Release: First UK Patients Enroll in Phase 3 Clinical Trials of LMTX™ for Alzheimer's Disease

Thu, 23 May 2013 12:00:00 AM GMT
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Aberdeen, United Kingdom, 22 May 2013 Coinciding with Dementia Awareness Week in the UK, TauRx Therapeutics Ltd announced that the first of more than 100 UK patients have enrolled in the global Phase 3 clinical...

Takeda Pharmaceutical Co. Ltd. Initiates TOURMALINE-MM2 Pivotal Phase 3 Trial of MLN9708 in Patients With Newly Diagnosed Multiple Myeloma

Thu, 23 May 2013 12:00:00 AM GMT
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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) today announced the initiation of an international phase 3 clinical trial evaluating once a week MLN9708 in combination with...

Opko Health, Inc. Surpasses 50% Enrollment in First Phase 3 Trial of Rayaldy™ (CTAP101 Capsules)

Thu, 23 May 2013 12:00:00 AM GMT
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MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE: OPK), has surpassed 50% enrollment in the first phase 3 trial of RayaldyTM to treat patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney...

Bayer HealthCare Says Lung Drug Shows Promise in Prolonged Trial

Wed, 22 May 2013 12:00:00 AM GMT
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Bayer Presents Positive Interim Results from Long-term Extension Study PATENT-2 with Riociguat

Berlin, May 20, 2013 Bayer HealthCare today announced positive data from...

Upsher-Smith Laboratories Successfully Completes Phase III Study of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Epilepsy in Patients With Refractory Partial-Onset Seizures

Wed, 22 May 2013 12:00:00 AM GMT
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MAPLE GROVE, Minn., May 22, 2013 /PRNewswire/ -- Upsher-Smith...

Salix Pharmaceuticals, Ltd. Announces Statistically Significant Results for Budesonide Foam in the Treatment of Active Mild to Moderate Ulcerative Proctitis or Ulcerative Proctosigmoiditis in Two Pivotal Phase 3 Studies

Wed, 22 May 2013 12:00:00 AM GMT
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RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful completion and outcome of two pivotal Phase 3 studies to evaluate the efficacy and safety of budesonide...

FDA Staff Says Merck & Co., Inc.'s Sleep Drug Effective, Questions Dosage

Tue, 21 May 2013 12:00:00 AM GMT
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Merck & Co. (MRK)s experimental insomnia drug, designed to turn off wakefulness rather than subdue the brain into slumber like Ambien, may only be safe at lower doses than what the company has proposed, U...

XenoPort, Inc. Drops Multiple Sclerosis Drug After Trial Failure

Tue, 21 May 2013 12:00:00 AM GMT
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SANTA CLARA, Calif., May 20, 2013 (BUSINESS WIRE) -- XenoPort, Inc. XNPT 4.33% announced today top-line results from its pivotal Phase 3 clinical trial of arbaclofen placarbil (AP) for the treatment of patients...

AMAG Pharmaceuticals, Inc. Release: Ferumoxytol Treatment Produced Significant Hemoglobin Increases in Adult Iron Deficiency Anemia Patients With Gastrointestinal Disease Who Had Failed or Could Not Tolerate Oral Iron Therapy

Tue, 21 May 2013 12:00:00 AM GMT
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LEXINGTON, Mass., May 21, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) announced that a new sub-group analysis from IDA-301, a phase III, randomized, placebo-controlled clinical trial, will...

Medivir AB Release: Primary Efficacy and Safety Findings From Phase III Study of Simeprevir in Treatment-Experienced Patients Demonstrate Sustained Virologic Response

Tue, 21 May 2013 12:00:00 AM GMT
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Stockholm, Sweden Medivir AB (OMX: MVIR) reports that its partner Janssen R&DIreland (Janssen) today announced primary efficacy and safety results from theglobal phase III PROMISE study. Results demonstrated...

Vectura Group plc Release: New Data Presented at the American Thoracic Society Meeting Highlights Strength of Once-Daily COPD Portfolio in Improving Lung Function, Shortness of Breath and Reducing Rate of Exacerbations

Tue, 21 May 2013 12:00:00 AM GMT
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Chippenham, UK 21 May 2013: Vectura Group plc (LSE: VEC) (Vectura), confirms theinformation released today by Novartis announcing that new data from the chronic obstructivepulmonary disease (COPD) portfolio...

Boehringer Ingelheim Corporation Release: Phase III Results: Tiotropium* Respimat® Effective in Symptomatic Asthma Patients Despite at Least ICS???/LABA??? Independent of Their Age, Allergic Status, Smoking Status and Bronchodilator Response

Tue, 21 May 2013 12:00:00 AM GMT
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PHILADELPHIA--(BUSINESS WIRE)--In patients with symptomatic asthma despite at least ICS/LABA therapy, tiotropium delivered by the Respimat SoftMistTM Inhaler increases time to first severe exacerbation and...

Primary Efficacy and Safety Findings from Phase 3 Study of Janssen Research & Development's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients

Tue, 21 May 2013 12:00:00 AM GMT
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ORLANDO, Fla., May 21, 2013 /PRNewswire/ -- Janssen R&D Ireland (Janssen) today announced primary efficacy and safety...

AstraZeneca PLC Release: Results From Phase III Studies of Naloxegol for Treatment of Opioid-Induced Constipation Presented at

Tue, 21 May 2013 12:00:00 AM GMT
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ORLANDO, Fla.--(BUSINESS WIRE)--AstraZeneca (NYSE: AZN) today presented the results of two pivotal Phase III studies of naloxegol showing the 25 mg dose of the investigational drug met its primary and secondary...

AcelRx Pharmaceuticals Drug Device Meets Main Goal of Late-Stage Study

Tue, 21 May 2013 12:00:00 AM GMT
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Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain

REDWOOD CITY...

Genentech Cancer Antibody, Son of Rituxan, Nails Pivotal Study

Mon, 20 May 2013 12:00:00 AM GMT
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Roche's obinutuzumab (GA101) significantly reduced the risk of disease progression or death in people with one of the most common forms of blood cancer

Basel, 16 May 2013 -- Roche (SIX: RO...

Sanofi (France) Plans to File JAK2 Inhibitor After Positive Phase III

Mon, 20 May 2013 12:00:00 AM GMT
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Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis

Paris, France - May 17, 2013- Sanofi (EURONEXT: SAN and...

Veloxis Pharmaceuticals A/S Release: Final STRATO Clinical Study Data Demonstrates Potential for LCP-TacroTM to Improve Tacrolimus-Induced Tremors

Mon, 20 May 2013 12:00:00 AM GMT
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Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that data from the STRATO study demonstrates the potential for LCP-Tacro to improve tacrolimus-induced tremors in stable kidney transplant patients. ...

Lundbeck Inc. Release: Vortioxetine Clinical Phase III Data Show Significant Improvement in Symptoms of Major Depression

Mon, 20 May 2013 12:00:00 AM GMT
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Valby, Denmark, 18 May 2013 - H. Lundbeck A/S (Lundbeck) and partner Takeda Pharmaceutical Company Limited (Takeda) today announced that the companies will be presenting new data on four pivotal studies on vortioxetine...

Takeda Pharmaceuticals and Lundbeck Inc. Present Results From Pivotal Phase 3 Clinical Trials With Vortioxetine, an Investigational Compound for Major Depressive Disorder

Mon, 20 May 2013 12:00:00 AM GMT
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SAN FRANCISCO, May 18, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck...

Veloxis Pharmaceuticals A/S Release: Final STRATO Clinical Study Data Demonstrates Potential for LCP-Tacro™ to Improve Tacrolimus-Induced Tremors

Mon, 20 May 2013 12:00:00 AM GMT
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HORSHOLM, Denmark, May 20, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that data from...

BioSpace.com News

Cell Therapeutics, Inc. Release: New EXTEND Analyses Evaluate Efficacy of Single Agent PIXUVRI® in 3rd and 4th Line Salvage Setting With and Without Prior Rituximab Treatment

Orexo AB Release: First Patient Dosed in New Phase III Study Targeted Towards a Future Clinical Indication Expansion for Zubsolv

NPS Pharmaceuticals, Inc. Release: Initial Findings from PARADOX, Largest and Most Comprehensive Research Analyzing the Burden of Hypoparathyroidism, Reveals Collection of Nearly 40 Physical, Cognitive, Emotional Symptoms

Orexo AB: First Patient Dosed in New Phase III Study Targeted Towards a Future Clinical Indication Expansion for Zubsolv

MannKind Corporation Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes

Incyte Corporation Drug Jakafi® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients With Myelofibrosis

These Mutated Cystic Fibrosis Cells are Worth Billions to Vertex Pharmaceuticals (MA)

Amgen Shows Off Phase 3 Ovarian Cancer Data

Boehringer Ingelheim Corporation Release: New Long-Term Data Published in /i> Reinforce Safety Profile of Pradaxa® (dabigatran etexilate mesylate)

Immunomedics, Inc. Presents Epratuzumab's Mechanism of Action in Systemic Lupus Erythematosus

Data and Safety Monitoring Board Recommends Continuation of Sunesis Pharmaceuticals, Inc.' VALOR Trial With No Change to Study Conduct

Janssen Research & Development Release: STELARA® Phase 3 Study Published in the Lancet Reports One Year Efficacy and Safety in Treatment of Active Psoriatic Arthritis

Intarcia Therapeutics, Inc. Supports American Diabetes Association Call For Independent Review Of Incretin-Based Therapies

Ferrer Internacional Successfully Completes a Phase III Clinical Trial in Adult and Paediatric Patients With Impetigo for Novel Antibacterial Compound Ozenoxacin

Trius Therapeutics Announces Publication of Antibiotic Safety Study in /i>

Celgene International S??rl Release: Signs and Symptoms of Psoriatic Arthritis Significantly Improved in Patients Receiving Long-Term Oral Apremilast Treatment in Phase III Study (PALACE-1)

Janssen Biotech Inc. Release: Five-Year SIMPONI Data Reported In Treatment of Signs and Symptoms of Moderately to Severely Active Rheumatoid Arthritis

Argos Therapeutics, Inc. Announces US and Global Expansion for Ongoing Pivotal Phase 3 ADAPT Study for Personalized Immunotherapy

Navidea Biopharmaceuticals Announces Results From Lymphoseek® Study on Accuracy of Lymph Node Detection From Injection Time to Surgery

Cerus Corporation Initiates Patient Enrollment in European Phase III Clinical Trials for INTERCEPT Red Blood Cells for Acute and Chronic Anemia

rEVO Biologics, an LFB Company, Announces Completion of a Dose Ranging Study of a Novel, Recombinant Form of Factor VIIa in Patients With Hemophilia A and B

Boehringer Ingelheim Corporation's Investigational Faldaprevir+ Achieved Viral Cure in 88% of Treatment-Naive Hepatitis C Patients in Asia

Adamas Pharmaceuticals to Report Positive Phase 2/3 Results For ADS-5102 for the Treatment of Levodopa-Induced Dyskinesia in Parkinson's Disease

Argos Therapeutics, Inc. Announces U.S. and Global Expansion for Ongoing Pivotal Phase 3 ADAPT Study for Personalized Immunotherapy

AMAG Pharmaceuticals, Inc. Announces Submission of a Type II Variation for Rienso Label Expansion in Europe to Include All Adult Iron Deficiency Anemia Patients Who Cannot Take Oral Iron

Puma Biotechnology Initiates Phase III Trial of PB272 (Neratinib) in HER2-Positive Metastatic Breast Cancer Patients

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. Say VEGF Trap-Eye Shows Promise as mCNV Treatment

AstraZeneca PLC Scraps Rigel Pharmaceuticals, Inc. Arthritis Pill in New R&D Blow, to Write Off $140 Million Charge

Medivir AB Release: Primary Efficacy and Safety Data From Four Phase III Japanese Studies of Simeprevir Presented at

Vanda Pharmaceuticals, Inc. Presents Data From Tasimelteon Phase III Studies in Non-24-Hour Disorder

ARCA biopharma Release: Gencaro™ Potential Efficacy in Preventing Atrial Fibrillation Paper Published in /i>: Heart Failure

Receptos Provides Update on Progress of Lead Product Candidate RPC1063

BioMarin Pharmaceutical Inc. Initiates Phase 3 Trial for PEG-PAL for the Treatment of PKU

Eli Lilly and Company Says Superiority Study of Alimta for Lung Cancer Fails to Meet Goals

Hospira, Inc. Data on European Biosimilar Epoetin, Retacrit, Affirm Treatment Response, Tolerability in Management of Anemia Secondary to Chemotherapy

PROLOR Biotech Initiates Pivotal Phase III Trial Of Its Longer-Acting Version Of Human Growth Hormone

CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A

Genentech's Avastin Fails Studies in New Brain Tumor Patients

Amgen Melanoma Drug Improved Survival by 21 Pct in Interim Look

Novartis AG Says BOLERO-3 Trial Meets Primary Endpoint

AstraZeneca PLC Advances PARP Inhibitor Into Phase 3 Trial With BRACAnalysis®

Boehringer Ingelheim Corporation Release: LUME-Lung 1: Nintedanib* Plus Chemotherapy Extends the Life of Lung Cancer Patients With Adenocarcinoma

Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc.'s Liver Cancer Drug Nexavar Slows Rare Thyroid Tumor

MannKind Corporation Completes Phase 3 Clinical Study of AFREZZA in Patients With Type 1 Diabetes

Ampio Pharmaceuticals, Inc. Provides Clinical Updates

Takeda Pharmaceutical Co. Ltd. Release: American Society of Clinical Oncology Presentation Highlights Results of Single Agent oral MLN9708 in Heavily Pretreated Patients with Relapsed and/or Refractory Multiple Myeloma

Celgene International S??rl Release: Analyses of MPACT Trial Evaluating ABRAXANE?? Combination Therapy for the Treatment of Advanced Pancreatic Cancer Presented at American Society of Clinical Oncology 2013

KAEL???GemVax Release: Final Results From the Phase III TeloVac Trial in Pancreatic Cancer Presented at American Society of Clinical Oncology, Chicago, June 3rd 2013.

Celgene International S??rl Release: Updated Studies Evaluating POMALYST® (pomalidomide) In Previously Treated Multiple Myeloma Patients Presented at American Society of Clinical Oncology

Janssen Therapeutics Release: Survey of Participants from Landmark GRACE Trial Provides Patients' Perspectives From an HIV Clinical Study

FDA Designates Alexion Pharmaceuticals Inc.'s Product for Rare Disease as "Breakthrough Therapy"

GlaxoSmithKline, Genmab A/S Say Combo Boosts PFS in P3 Leukemia Study

Beijing Vigoo Biological Says EV71 Vaccine Passes Phase III Test

Sunesis Pharmaceuticals, Inc. Release: Vosaroxin Review Published in /i>

Amarin Corporation PLC Announces Additional Effects of Vascepa® on Lipoprotein Particle Concentration From the ANCHOR Study Presented at the Annual Scientific Sessions

NeuroVive Pharmaceutical AB: European Phase III Study Approaches Its Final Stage

Novo Nordisk A/S Says Obesity Drug Trial Confirms Weight Loss

SALVAT Completes Enrollment of Phase III Study for a New Combination in Acute Otitis Media in Pediatric Patients With Tympanostomy Tubes (AOMT)

Zensun Announces Positive Clinical Results for Neucardin™ to Improve Heart Function and Reduce Mortality in Chronic Heart Failure Patients

TauRx Therapeutics Release: First UK Patients Enroll in Phase 3 Clinical Trials of LMTX™ for Alzheimer's Disease

Takeda Pharmaceutical Co. Ltd. Initiates TOURMALINE-MM2 Pivotal Phase 3 Trial of MLN9708 in Patients With Newly Diagnosed Multiple Myeloma

Opko Health, Inc. Surpasses 50% Enrollment in First Phase 3 Trial of Rayaldy™ (CTAP101 Capsules)

Bayer HealthCare Says Lung Drug Shows Promise in Prolonged Trial

Upsher-Smith Laboratories Successfully Completes Phase III Study of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Epilepsy in Patients With Refractory Partial-Onset Seizures

Salix Pharmaceuticals, Ltd. Announces Statistically Significant Results for Budesonide Foam in the Treatment of Active Mild to Moderate Ulcerative Proctitis or Ulcerative Proctosigmoiditis in Two Pivotal Phase 3 Studies

FDA Staff Says Merck & Co., Inc.'s Sleep Drug Effective, Questions Dosage

XenoPort, Inc. Drops Multiple Sclerosis Drug After Trial Failure

AMAG Pharmaceuticals, Inc. Release: Ferumoxytol Treatment Produced Significant Hemoglobin Increases in Adult Iron Deficiency Anemia Patients With Gastrointestinal Disease Who Had Failed or Could Not Tolerate Oral Iron Therapy

Medivir AB Release: Primary Efficacy and Safety Findings From Phase III Study of Simeprevir in Treatment-Experienced Patients Demonstrate Sustained Virologic Response

Vectura Group plc Release: New Data Presented at the American Thoracic Society Meeting Highlights Strength of Once-Daily COPD Portfolio in Improving Lung Function, Shortness of Breath and Reducing Rate of Exacerbations

Boehringer Ingelheim Corporation Release: Phase III Results: Tiotropium* Respimat® Effective in Symptomatic Asthma Patients Despite at Least ICS???/LABA??? Independent of Their Age, Allergic Status, Smoking Status and Bronchodilator Response

Primary Efficacy and Safety Findings from Phase 3 Study of Janssen Research & Development's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients

AstraZeneca PLC Release: Results From Phase III Studies of Naloxegol for Treatment of Opioid-Induced Constipation Presented at

AcelRx Pharmaceuticals Drug Device Meets Main Goal of Late-Stage Study

Genentech Cancer Antibody, Son of Rituxan, Nails Pivotal Study

Sanofi (France) Plans to File JAK2 Inhibitor After Positive Phase III

Veloxis Pharmaceuticals A/S Release: Final STRATO Clinical Study Data Demonstrates Potential for LCP-TacroTM to Improve Tacrolimus-Induced Tremors

Lundbeck Inc. Release: Vortioxetine Clinical Phase III Data Show Significant Improvement in Symptoms of Major Depression

Takeda Pharmaceuticals and Lundbeck Inc. Present Results From Pivotal Phase 3 Clinical Trials With Vortioxetine, an Investigational Compound for Major Depressive Disorder