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Clinical Trials

Pertuzumab (Perjeta) Regimen Extends Survival in Women With Metastatic Breast Cancer

Treatment compared with trastuzumab and chemotherapy in phase III study

Afatinib (Gilotrif) Superior to Erlotinib (Tarceva) in Late-Stage Lung Cancer Trial

Progression-free survival improved in patients with squamous-cell carcinoma

Bevacizumab/Capecitabine Combo Shows Promise in Women With HER2-Negative Metastatic Breast Cancer

Phase III trials demonstrate improved survival

Secukinumab Meets Key Objectives in Phase III Trials

Monoclonal antibody improves psoriatic arthritis

Positive Late-Stage Data Reported for Glaucoma Candidate Vesneo (Latanoprostene Bunod)

FDA submission expected in mid-2015

Single-Tablet HIV Regimen Shows Promise in Late-Stage Studies

Trials meet 48-week primary objectives

Oral Testosterone Replacement Therapy Meets Phase III Goals

Treatment restores testosterone levels in 88% of subjects

Elusys Completes Phase III Studies Of Anthrax Anti-Toxin

The biologic appears well tolerated

Positive Results Reported for Insulin Degludec/Insulin Aspart (Ryzodeg) in Phase III Diabetes Trial

Combo therapy requires fewer injections than basal–bolus regimen

Ramucirumab/Paclitaxel Improves Survival in Second-Line Gastric Cancer Patients

Phase III data support combination of biologic agent and chemotherapy

Pancreatic Cancer Drug Simtuzumab Fails Mid-Stage Study

Monoclonal antibody equivalent to placebo in improving survival

Insulin Degludec (Tresiba) Demonstrates Long-Term Efficacy in Children and Adolescents With Type-1 Diabetes

Treatment noninferior to insulin detemir

Positive Phase III Data Reported for Osteoporosis Drug Odanacatib

Cathepsin K inhibitor reduces fracture risk

Ivabradine Shows Promise in Phase III Heart Failure Trial

FDA approval decision expected in February 2015

Positive Results Reported for Ramucirumab (Cyramza) in Phase III Second-Line Colorectal Cancer Study

Treatment provides survival benefit

Fingolimod (Gilenya) Achieves ‘No Evidence of Disease Activity’ in MS Patients

Drug targets both focal and diffuse CNS damage

Positive Phase III Results Reported for Humira (Adalimumab) in Treatment of Inflammatory Skin Disease

No approved treatment options available for hidradenitis suppurativa

Two-Year Data Confirm Efficacy of Plegridy (Peginterferon Beta-1a) in MS Patients

Subjects demonstrate improvement in clinical and MRI outcomes

Asthma Drug Mepolizumab Shows Promise in Phase III Studies

Treatment reduces exacerbations and corticosteroid use

Once-Daily Ultibro Breezhaler Superior to Twice-Daily Seretide Accuhaler in Reducing COPD Flare-Ups

Exacerbations reduced by 31%

Peramivir Injection Shows Promise Against Influenza

FDA approval decision expected in December

Positive Phase III Results Reported for Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients

Combo therapy submitted for FDA review in April

Basal Insulin Peglispro Superior to Insulin Glargine in Phase III Studies

New drug application expected in early 2015

Extended-Release Hydrocodone/ Acetaminophen Combo Shows Efficacy Against Acute Pain

Treatment under FDA review

Positive Phase III Results Reported for Anti-Cancer Agent Xilonix

‘True human’ monoclonal antibody treats colorectal cancer

Company Responds to FDA’s Concerns About Rifaximin (Xifaxan) for Repeat Treatment of IBS With Diarrhea

Phase III trial finds significantly greater symptom relief versus placebo

High-Dose Rosuvastatin (Crestor) Shrinks Coronary Plaque in Heart Attack Patients

Study is first to use ultrasound imaging inside coronary arteries

Cabozantinib (Cometriq) Fails to Meet Primary Endpoint in Pivotal Study of Men With Metastatic Prostate Cancer

Drug currently approved for thyroid cancer

Irinotecan-Based Therapy Shows Promise in Subset of Stage III Colon Cancer Patients

CIMP status plays crucial role

Crizotinib/Pembrolizumab Combo to Be Tested in Lung Cancer Patients

Pharma giants join forces

Psoriasis Drug Ixekizumab Superior to Etanercept in Phase III Studies

Regulatory submission expected in early 2015

New Skin Wound-Healing Compound Shows Promise in First Clinical Trial

ACT1 peptide stops immune response

Positive Phase III Results Reported for BAX 855 in Treatment of Hemophilia A

Prophylaxis more effective than on-demand therapy

Ceftazidime/Avibactam Shows Promise in Patients With Complicated Intra-Abdominal Infections

Combo therapy noninferior to merepenem in phase III trials

Intra-Articular Treatment (Ampion) Shows Promise in Early OA Trial

Endogenous immunomodulatory molecule reduces inflammation

Ribavirin-Free Regimen (ACH-3102/Sofosbuvir) Achieves 100% Response Rate in HCV Patients

Interim data reported from mid-stage trial

Positive Phase III Results Reported for Gout Drug Lesinurad

Combo treatment with XO inhibitors reduces uric acid levels

Positive Results Reported for Concentrated Insulin (BIOD-531) in Mid-Stage Trial

Treatment more effective than Humalog Mix 75/25 and Humulin R U-500

Breast Cancer Drug Eribulin (Halaven) Fails Lung Cancer Trial

No survival improvement in phase III study

Phase III Trial of Carfilmozib (Kyprolis) in Multiple Myeloma Meets Primary Endpoint

Treatment extends progression-fee survival

Positive Phase III Results Reported for Ofatumumab (Arzerra) as Maintenance Therapy for Relapsed CLL

Treatment achieves significance level for efficacy

Positive Results Reported From Nine Phase III Trials of Alirocumab in Hypercholesterolemia

Antibody targets PCSK9 protein

Simeprevir/Sofosbuvir Combo Provides Sustained Virologic Response in HCV Patients

Positive mid-stage data published in The Lancet

ThermaDox Shows Promise in Primary Liver Cancer

Treatment combines heat-activated doxorubicin and RFA

Sorafenib/Capecitabine Combo Fails to Meet Primary Endpoint in Breast Cancer Trial

Treated patients show no improvement in progression-free survival

Positive Phase III Results Reported for Brivaracetam in Epilepsy Patients

New drug application expected early next year

Breast Cancer Drug Neratanib Meets Trial Goal

Treatment extends disease-free survival versus placebo

Trametinib/Dabrafenib Combo Shows Survival Benefit Versus Vemurafenib in Melanoma Patients

Phase III trial stopped early

New Coagulation Factor Shows Promise as Once-Weekly Prophylaxis for Hemophilia B

Bleeding reduced compared with on-demand treatment

Positive Phase IV Data Reported for Nuedexta (Dextromethorphan/ Quinidine) in Patients With Alzheimer’s Disease/Dementia

Treatment reduces symptoms of pseudobulbar affect

Alzheimer’s Drug Fails Mid-Stage Study

TC-1734 not superior to donepezil, researchers find

Melanoma Treatment Cobimetinib Helps Prolong Survival in Phase III Trial

Study investigates cobimetinib/vemurafinib combo

Positive Results Reported for Psoriasis Drug Secukinumab in Phase III Trials

Data show superiority over etanercept

Positive Phase III Results Reported for BEMA Buprenorphine in Opioid-Experienced Patients With Chronic Pain

FDA meeting scheduled for July

Little Benefit From Corticosteroid Injections for Pain of Spinal Stenosis

Treatment fails to enhance lidocaine’s anesthetic effects

Study: Everolimus Does Not Improve Survival in Liver Cancer Patients

Failed phase III trials offer important lessons

Brain Cancer Vaccine Improves Survival in Mid-Stage Trial

Prophage tested in glioblastoma patients

Study Shows TAS-102 Improves Survival in Refractory Metastatic Colorectal Cancer

Phase III RECOURSE findings to form foundation for FDA submission

Emend Eases Children’s Chemotherapy-Induced Nausea and Vomiting, Study Shows

Merck plans FDA submission in second half of 2014

Positive Phase III Results Reported for Angiogenic Gene Therapy in Patients With Myocardial Ischemia

Generx promotes growth of microvascular circulation in the heart

Lumacaftor/Ivacaftor Combo Improves Lung Function in CF Patients

Findings reported from two phase III trials

Vilazodone (Viibryd) Shows Promise as Anxiety Treatment in Phase III Studies

Trials meet primary endpoint of improved HAM-A scores

Phase III Trials: Naloxegol Improves Opioid-Induced Constipation in Pain Patients

FDA approval decision expected in September

Takeda Halts Development of Prostate Cancer Drug Orteronel

Treatment has no effect on overall survival

Aripiprazole Lauroxil Shows Promise in Late-Stage Schizophrenia Trial

Once-monthly treatment reduces PANSS scores

Antiepileptic Drug Perampanel (Fycompa) Meets Primary Endpoints in Phase III Trial

Treatment is approved in U.S. for adjunctive therapy of partial-onset seizures

Dulaglutide Superior to Insulin Glargine in Phase III Trials

Treatment reduces hemoglobin with lower risk of hypoglycemia

Daclizumab Superior to IFN Beta in Phase III Multiple Sclerosis Trial

Relapse rate reduced

Positive Results Reported for Vortioxetine (Brintellix) in Patients With Major Depressive Disorder

Treatment approved in 2013

New Data on Liraglutide (Victoza) in Adults With Type-2 Diabetes

Phase III study shows increased glycemic control versus placebo

Pancreatic Cancer Vaccine Enters Mid-Stage Trial

Researchers evaluate genetically modified bacterium

Small-Particle Meloxicam Shows Promise in Treatment of OA Pain

Low-dose therapy evaluated in phase III trial

Liver Cancer Treatment Ramucirumab (Cyramza) Fails to Meet Primary Endpoint in Pivotal Trial

Overall survival similar between active treatment and placebo

Romosozumab Increases Bone Density in Postmenopausal Women

New findings presented at EULAR congress

First-Line Leukemia Drug Pracinostat Shows Promise in Phase II Study

Initial data indicate overall response rate of 67%

Positive Results Reported From Head-to-Head Comparison of Intranasal Versus Oral Sumatriptan for Migraine Pain

Intranasal form shows significant pain reduction within 30 minutes after use

Positive Pivotal Data Reported for Tedizolid Phosphate (Sivextro) in Treatment of Skin Infections

Treatment noninferior to linezolid in phase III trial

New Pancreatic Cancer Treatment Shows Promise in Phase III Study

Irinotecan liposome injection helps prolong overall survival

Phase III Study: Once-Weekly Dalbavancin as Effective as Twice-Daily Vancomycin in Treating Bacterial Skin Infections

Authors see reduced need for hospital admission

Ivacaftor (Kalydeco) Monotherapy Improves Lung Function in CF Patients With Residual Function Mutation

Clinical effect observed within 2 weeks

Alzheimer’s Drug Halts Clinical Progression in Mid-Stage Trial

First treatment to meet FDA’s disease-modification criteria

Positive Results Reported From Pivotal Phase III Trial of Ruxolitinib (Jakafi) in Polycythemia Vera

Study meets primary composite endpoint of hematocrit control and reduced spleen volume

NIH Study: Drug Combination May Be Effective for Recurrent Ovarian Cancer

Early data support treatment with olaparib and cediranib

Positive Results Reported for Panobinostat in Pivotal Myeloma Trial

Investigators report improvement in progression-free survival

Yervoy (Ipilimumab) Meets Primary Endpoint in Phase III Melanoma Trial

Recurrence-free survival shows significant improvement

Immune System Booster Pembrolizumab Effective in Skin, Lung Cancer in Early Study

Treatment shrinks tumors in both cohorts

Immunotherapy for Melanoma Demonstrates Clinical Efficacy in Phase II Trial

Genetically modified melanoma cells elicit immune response

Breast Cancer Test Predicts Late Recurrence

Clinicians can identify patients who will benefit most from extended hormonal therapy

Gastroesophageal Cancer Treatment Shows Promise in Mid-Stage Trial

Antibody reduces disease progression

Positive Results Reported for Targeted Immunotherapy in Lung Cancer Patients

Investigators evaluate recombinant vaccinia virus

Positive Results Reported for Kallikrein Inhibitor in Patients With Hereditary Angioedema

Mid-stage trial shows reduced angioedema attack rate compared with placebo

Idebenone (Catena/Raxone) Shows Promise in Phase III Study of Patients With Duchenne Muscular Dystrophy

Respiratory function endpoints corroborate previous positive data

Positive Results Reported for Tiotropium/Olodaterol Combo in Patients With COPD

Phase III data show improved lung function

Ofatumumab Fails to Meet Primary Endpoint in Head-to-Head Comparison With Rituximab

No difference in progression-free survival in lymphoma patients

Positive Results Reported for Pulmonary Hypertension Drug Riociguat (Adempas) in Phase III Trial

One-year data show sustained improvement

Positive Mid-Stage Data Reported for Investigational Clostridium difficile Vaccine

Candidate vaccine generates immune response against C. difficile toxins A and B

Liraglutide Helps Obese Patients Lose Weight in Phase III Study

Treatment improves blood glucose levels, blood pressure, and lipids levels

Orteronel/Prednisone Combo Improves Progression-Free Survival in Men With Metastatic Prostate Cancer

Improvement in overall survival not statistically significant

Mixed Results Reported for Inhaled Emphysema Drug in Pivotal Trial

Study fails to meet primary endpoint

Pooled Data Show Benefits of Linagliptin (Tradjenta) in African-American Adults With Type-2 Diabetes

Phase III trials compare linagliptan and placebo

Virus Vaccine Wipes Out Woman’s Cancer

Researchers evaluate oncolytic virotherapy in myeloma patients

Lung Cancer Drug Necitumumab Improves Survival in Phase III Trial

Largest phase III study ever conducted in first-line squamous NSCLC

Positive Phase III Data Reported for Antifungal Agent Isavuconazole

Superiority over voriconazole demonstrated in patients with invasive aspergillosis

Diabetes Drug ISIS-GCGRRx Shows Promise in Mid-Stage Trial

HbA1c reduced by more than 2% after 13 weeks of dosing

Phase III Study of Heart Drug Darapladib Fails to Meet Primary Endpoint

Lp-PLA2 inhibitor equivalent to placebo in reducing coronary events

Evolocumab Reduces LDL Cholesterol in Statin-Treated Patients

Treatment effect is evident regardless of statin dose

Late-Stage Data Support Efficacy of Saxagliptin/Dapagliflozin in Patients With Type 2 Diabetes

Combo treatment reduces hemoglobin compared with individual components

Basal Insulin Peglispro Tops Insulin Glargine in Three Phase III Trials

Regulatory submission scheduled for early 2015

Trifluridine/Tipiracil (TAS-102) Improves Survival in Colorectal Cancer Patients

Phase III data to be presented at oncology congress

Rolapitant Shows Promise in Prevention of Chemo-Induced Nausea and Vomiting

FDA submission expected in mid 2014

Positive Results Reported From Late-Stage Study of Brodalumab (AMG 827) in Patients With Plaque Psoriasis

IL-17 receptor antibody improves disease severity versus placebo

First-in-Class, Non-Antibiotic Treatment for Acne Vulgaris Shows Promise in Mid-Stage Trial

Positive data reported at dermatology meeting

Positive Results Reported for Non-Stimulant Therapy (EB-1020 SR) in Adults With ADHD

Medication shows stimulant-like efficacy

Phase III Immunotherapy Study Evaluates MEDI4736 in Patients With Lung Cancer

Monoclonal antibody counters tumors’ immune-evading tactics

Vonoprazan Fumarate Shows Promise for Treatment of Acid-Related Diseases

Phase III data demonstrate non-inferiority to lansoprazole

Acromegaly Drug Pasireotide LAR Shows Promise in Late-Stage Trial

Treatment achieves biochemical disease control

Mixed Results Reported for NGR-hTNF in Patients With Mesothelioma

Trial fails to meet primary endpoint

Long-Term Safety Data Reported for Certolizumab Pegol (Cimzia) in Crohn’s Disease

Seven-year results presented at Digestive Disease Week

Ovarian Cancer Drug Vintafolide Fails Phase III Trial

Treatment has no effect on progression-free survival

New Version of Old MS Drug Performs Well in Clinical Trial

Scientists test long-acting peg-interferon

Combo Therapy Improves Survival in Pancreatic Cancer Patients

Phase III trial evaluates irinotecan liposome injection

Intranasal Capsaicin Shows Promise for Pain Relief of Severe Headaches and Migraine

Treatment desensitizes trigeminal nerve

Estriol/Copaxone Reduces Relapse in Women With MS

Mid-stage trial shows efficacy over 1 year

Inhaled Levodopa Shows Promise for Treatment of Parkinson’s Disease

Therapy provides relief from 'off' episodes

Positive Data Reported for RSV Vaccine in Women of Childbearing Age

Mid-stage trial shows increase in antibody levels

Stem Cell Study in ALS Patients Gets FDA Green Light

Mesenchymal stromal cells secrete neurotropic factors

Mixed Results Reported From Phase II Trial of CTP-499 in Diabetic Kidney Disease

PDE inhibitor fails to meet primary endpoint

Late-Stage Trial Shows Inhaled Indacaterol Noninferior to Salmeterol/Fluticasone for COPD

Phase IV study meets primary objective

Positive Phase III Data Reported for Sorafenib in Thyroid Cancer Patients

First effective therapy for patients with progressive disease after standard treatments

New TB Drug Regimen Moves to Phase III Trial

Study will test first therapy for both drug-sensitive and drug-resistant disease

Glioblastoma Vaccine Shows Promise in Early Trial

Ninety percent of subjects respond to treatment

Captisol-Enabled Melphalan Meets Primary Endpoint in Melanoma Trial

Product does not contain propylene glycol

New Drugs Offer Hope for Migraine Prevention

Monoclonal antibodies target calcitonin gene-related peptide

Positive Results Reported From Two Phase III Trials of Tofacitinib (Xeljanz) in Adults With Plaque Psoriasis

Pfizer will seek new indication for arthritis drug

New Trials Will Assess Muscle Disorder Drug After FDA Criticism

Agency says previous data may not support approval of eteplirsen

Sprifermin Shows Mixed Results in Knee OA

One-year data reported from proof-of-concept trial

New Kind of Trial Speeds Development of Cancer Drugs

Up to 14 medications can be studied at one time

Psoriasis Drug Meets Primary Endpoint in Phase II Study

GSK2586184 improves Psoriasis Area Severity Index

Promising Results Reported for Remogliflozin Etabonate in Mid-Stage Diabetes Trials

SGLT2 inhibitor reduces hemoglobin A1c

Recombinant Treatment for von Willebrand Disease Meets Primary Efficacy Endpoint in Phase III Trial

NDA submission expected before end of year

Pivotal Phase III Study Evaluates Veliparib (ABT-888) in Lung Cancer Patients

Treatment added to standard chemotherapy with carboplatin and paclitaxel

Immune Modulator CYT003 Fails Asthma Study

Company faces bankruptcy

Diabetes Drug LX4211 Achieves Primary Endpoint in Phase II Trial

Need for mealtime insulin reduced

Late-Stage Trial Supports Efficacy of Obeticholic Acid in Patients With Biliary Cirrhosis

Data expected to be submitted to FDA at end of 2014

HCV Combo Therapy Demonstrates Antiviral Activity in Hard-to-Cure Patients

MK-5172/MK-8742 shows promise in mid-stage trial

Study: Hepatitis C Combo Therapy Cures Up to 90%

Data reinforce potential of daclatasvir-based regimens

Positive Efficacy and Safety Results Reported From Phase III Pediatric Study of Eloctate (rFVIII-Fc) for Hemophilia

Twice-weekly prophylactic dosing maintains low bleeding rates

Positive Results Reported From Pivotal Phase III Study of Aripiprazole Lauroxil for Treatment of Schizophrenia

Once-monthly injection achieves primary and secondary endpoints

Positive Results Reported for Palbociclib Plus Letrozole in Patients With Advanced Breast Cancer

Combo therapy prolongs survival in mid-stage trial

Mixed Results Reported for Talimogene Laherparepvec in Patients With Metastatic Melanoma

Treatment shrinks tumors but doesn’t improve survival in phase III trial

Resiniferatoxin Shows Promise as Cancer Pain Treatment

Intractable pain improved with single injection

Intravitreal Sirolimus Meets Phase III Goal as Uveitis Therapy

Study tests nonsteroidal alternative to current treatments