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Clinical Trials

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 Drugs Offer Hope for Migraine Prevention

Monoclonal antibodies target calcitonin gene-related peptide

Captisol-Enabled Melphalan Meets Primary Endpoint in Melanoma Trial

Product does not contain propylene glycol

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

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

SGLT2 inhibitor reduces hemoglobin A1c

Psoriasis Drug Meets Primary Endpoint in Phase II Study

GSK2586184 improves Psoriasis Area Severity Index

New Kind of Trial Speeds Development of Cancer Drugs

Up to 14 medications can be studied at one time

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

Treatment added to standard chemotherapy with carboplatin and paclitaxel

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

NDA submission expected before end of year

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

Data expected to be submitted to FDA at end of 2014

Diabetes Drug LX4211 Achieves Primary Endpoint in Phase II Trial

Need for mealtime insulin reduced

Immune Modulator CYT003 Fails Asthma Study

Company faces bankruptcy

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

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

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

Study: Hepatitis C Combo Therapy Cures Up to 90%

Data reinforce potential of daclatasvir-based regimens

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

Intravitreal Sirolimus Meets Phase III Goal as Uveitis Therapy

Study tests nonsteroidal alternative to current treatments

Resiniferatoxin Shows Promise as Cancer Pain Treatment

Intractable pain improved with single injection

Mixed Results Reported for Talimogene Laherparepvec in Patients With Metastatic Melanoma

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

Votrient (Pazopanib) Tops Sutent (Sunitinib) in Patient Preference Study

Phase III assessment compares renal cancer therapies

Glaxo Walks Away From Lung Cancer Vaccine

Trial data fail to identify subgroup that would benefit from treatment

Evolocumab Reduces LDL Cholesterol in Phase III Studies

Treatment is significantly more effective than ezetimibe

Disappointing Late-Stage Results Reported for Darapladib in Patients With Chronic CHD

Trial fails to meet primary endpoint

Heart Failure Compound LCZ696 Shows Promise in Phase III Trial

Study closes early after endpoints are met

Psoriasis Drug Shows Promise in Mid-Stage Trial

Toll-like receptor antagonist meets primary endpoint of safety and tolerability

Bococizumab Reduces LDL Cholesterol in Phase II Study

Monoclonal antibody blocks function of PCSK9 protein

Xalkori (Crizotinib) Tops Chemotherapy in Lung Cancer Trial

Phase III data show prolonged progression-free survival

Monoclonal Antibody Guselkumab Shows Promise in Treatment of Plaque Psoriasis

Phase II trial demonstrates drug's efficacy in moderate-to-severe disease

Small, Wireless Pacemaker Is Safe, Effective in Early Testing

Device may reduce risk of complications associated with traditional pacemakers

Herpes Simplex Vaccine Reduces Symptoms at 6 Months

Early-stage trial achieves reductions in both clinical lesion days and rate of viral shedding

New Pain Device May Reduce Chemo-Induced Pain Scores by 30%

Study evaluates cancer patients

Self-Administered Psoriasis Drug Shows Promise in Late-Stage Trial

Secukinumab delivers significant skin clearance at 12 weeks

Phase III Trials Evaluate Antibiotic Candidate Eravacycline

Investigational treatment targets multidrug-resistant infections

Positive Results Reported for Adjunctive Treatment With Caripazine in Patients With Major Depressive Disorder

Drug significantly improves depression rating score versus placebo

Vintafolide/Docetaxel Shows Promise in Lung Cancer Patients

Combo therapy improves progression-free survival in phase IIb study

Lung Cancer Drug Fails Another Late-Stage Trial

Testing of MAGE-A3 immunotherapy continues

Statins Slow Progression of Advanced MS in Clinical Trial

Researchers find unlikely new weapon

Evolocumab Shows Promise in Patients With Familial Hypercholesterolemia

Positive phase III results reported

Positive Results Reported for Bile Acid Analog in Pivotal Phase III Study

Treatment reduces alkaline phosphatase in patients with biliary cirrhosis

Bladder Cancer Patient With Rare Genetic Mutations Responds to Everolimus

Findings support targeted therapies

New NSAID Polmacoxib Shows Promise in OA Patients

Phase III trial demonstrates non-inferiority to celecoxib

Landmark Study Provides Positive Data for Prevnar 13 in Older Adults

Multi-valent vaccine prevents community-acquired pneumonia

Asthma Drug Mepolizumab Shows Promise in Phase III Trials

IL-5 antibody reduces both exacerbations and corticosteroid use

Positive Phase III Results Reported for Extended-Release Hydrocodone Bitartrate

Opioid analgesic incorporates abuse-deterrent technology

Sorafenib (Nexavar) Fails Phase III Trial in Patients With Liver Cancer

Treatment has no effect on recurrence-free survival

Study: Erlotinib (Tarceva) May Prolong Survival in Women With Cervical Cancer

Treatment is indicated for NSCLC and pancreatic cancer in U.S.

NIH Launches Study of New Tinnitus Treatment Device

Technique combines audio tone therapy and vagus nerve stimulation

Positive Phase III Data Reported for Jakafi (Ruxolitinib) in Patients With Rare Blood Cancer

Treatment currently approved for myelofibrosis patients in U.S.

Positive Phase III Results Reported for Faldaprevir in HCV/HIV Co-Infected Patients

Oral protease inhibitor targets viral replication in the liver

Lebrikizumab Reduces Asthma Attack Rate in Mid-Stage Trials

Improved lung function linked to periostin biomarker

Asthma Treatment Shows Promise in Mid-Stage Trial

CRTh2 antagonist improves lung function versus placebo

Multi-Drug Hepatitis C Regimen Meets Phase III Endpoints

Sustained virologic response achieved in 99% of patients

Positive Late-Stage Data Reported for Tiotropium in Asthma Patients

Treatment improves lung function in mild, moderate, and severe disease

Lung Cancer Drug Onartuzumab Fails Phase III Study

Trial halted because of lack of efficacy

Postsurgery Painkiller Exparel (Bupivacaine) Effective in Late-Stage Trial

FDA filing expected soon (February 27)

Pirfenidone Delays Progression of Pulmonary Fibrosis in Late-Stage Study

Progression-free survival significantly improved versus placebo (February 25)

Once-Weekly Dulaglutide Non-Inferior to Liraglutide in Phase III Diabetes Trial

Hemoglobin A1c reduced at 26 weeks (February 25)

Prevnar 13 Prevents Community-Acquired Pneumonia in Older Adults

Pivotal trial meets primary objective in subjects aged 65 years and older (February 24)

New Phase III Study Evaluates Masitinib in Prostate Cancer

Combo treatment with docetaxel viewed as first-line therapy (February 20)

Apixaban (Eliquis) Superior to Warfarin in Phase III Trial

Subanalysis finds reduced risks of stroke and bleeding (February 21)

Huntington’s Disease Drug Shows Promise in Phase II/III Trial

Treatment slows loss of muscle control (February 20)

Positive Mid-Stage Results Reported for Oral Antifungal Compound

VT-1161 treats vulvovaginal candidiasis (February 18)

Ramucirumab Meets Primary Endpoints in Phase III Lung Cancer Trial

Combination treatment with docetaxel improves survival (February 19)

Breast Cancer Vaccine Shows Promise in Mid-Stage Trial

Compound activates immune cells (February 12)

Treatment for Anxious Depression Fails Mid-Stage Trial

First-in-class allosteric modulation-based drug is no better than placebo (February 7)

Positive Long-Term Results Reported for Aflibercept (Eylea) in Patients With Diabetic Macular Edema

Phase III trial shows improved visual acuity versus laser photocoagulation (February 10)

Vyvanse (Lisdexamfetamine Dimesylate) Fails Phase III Studies in Adults With Major Depressive Disorder

Shire terminates clinical development program (February 6)

Positive Results Reported for Golimumab (Simponi) in Patients With Ulcerative Colitis

Treatment induces clinical response in phase III trials (February 5)

EMA401 Reduces Pain of Postherpetic Neuralgia in Mid-Stage Trial

AT2 receptor antagonist meets primary endpoint (February 5)

Amgen and Merck Collaborate on Combo Treatment for Advanced Melanoma

Clinical trial to begin in fall of 2014 (February 5)

Zoptarelin Doxorubicin Shows Promise in Patients With Endometrial Cancer

Hybrid molecule consists of peptide carrier and chemotherapy agent (February 4)

Positive Phase III Data Reported for IBS Drug Eluxadoline

Response rates significantly higher versus placebo (February 4)

More Phase III Results Confirm Response to Investigational Hepatitis C Regimen

All-oral, interferon-free therapy studied with and without ribavirin in 2,300 patients (January 31)

Positive Results Reported From Late-Stage Trial of Evolocumab in Patients With Familial Hypercholesterolemia

Study meets co-primary endpoints of LDL cholesterol reduction (January 31)

Antibody Fails Mid-Stage Study in Asthma Patients

Treatment is no better than placebo in improving pulmonary function (January 29)

Oral Insulin Capsule for Type 2 Diabetes Shows Promise in Phase II Trial

Study meets all endpoints (January 30)

Positive Late-Stage Data Reported for Enzalutamide (Xtandi) in Men With Metastatic Prostate Cancer

Treatment provides significant survival benefits (January 28)

Updated Results Reported for ThermoDox in Primary Liver Cancer

Doxorubicin plus radio frequency ablation improves overall survival (January 27)

Lung Cancer Drug Dacomitinib Fails Two Phase III Trials

Treatment provides no survival benefit compared with erlotinib or placebo in NSCLC patients (January 27)

Positive Results Reported From Phase III Trial of BEMA Buprenorphine in Opioid-Naïve Patients With Chronic Pain

Pain relief significantly improved versus placebo (January 23)

New Data on Brexpiprazole in Major Depressive Disorder

Serotonin–dopamine activity modulator completes phase III study (January 24)

Combo Therapy Meets Main Goal in Melanoma Trial

Dabrafenib and trametinib increase progression-free survival (January 24)

New Drug Shows Promise in Treating Indolent Non-Hodgkin Lymphomas

Idelalisib could be on market later this year (January 22)

Inhaled Glycopyrronium Improves Lung Function in COPD Patients

Phase II study evaluates once-daily, orally inhaled monotherapy (January 23)

Positive Results Reported for Evolocumab in Statin-Intolerant Patients With High Cholesterol

Phase III study meets co-primary endpoints of LDL cholesterol reduction (January 23)

Positive Results Reported for Metoclopramide Nasal Spray for Gastroparesis in Diabetics

Intranasal delivery more effective than oral tablets in mid-stage trial (January 22)

Varenicline (Chantix) Demonstrates Smoking-Cessation Efficacy

Subjects were unable or unwilling to quit (January 21)

Disappointing Results Reported for Schizophrenia Drug Bitopertin in Late-Stage Trials

Treatment fails to improve negative symptoms (January 21)

Stem Cell Therapy Following Knee Surgery May Reduce Pain, Restore Meniscus

First study of its kind assesses knee injection (January 16)

Positive Phase III Results Reported for Lanreotide (Somatuline) in Patients With Carcinoid Syndrome

Drug improves chances of treatment success versus placebo (January 17)

Atherosclerosis Drug Shows Promise in Mid-Stage Studies

Significantly fewer major events in CVD patients (January 15)

Positive Phase II Data Reported for Bevacizumab (Avastin) in Cervical Cancer Patients

Two-year survival rate nears 90% (January 15)

Flu Vaccine Shows Promise in Phase III Trials

Studies test subcutaneous and intramuscular administration (January 15)

Ovarian Cancer Treatment Shows Promise in Mid-Stage Trial

Nanopharmaceutical releases camptothecin (January 13)

Early Data Are Promising for Oral H1N1 Flu Vaccine

Antibody response observed in nearly 90% of subjects (January 10)

Liver Drug Meets Primary Endpoint in Late-Stage Trial

Obeticholic acid treats nonalcoholic fatty liver disease (January 9)

Hypertension Device Ineffective in Pivotal Study

Radiofrequency energy deactivates renal nerves (January 9)

Lung Cancer Immunotherapy Shows Promise in Mid-Stage Trial

Treatment improves overall response versus antibody/chemotherapy combo (January 7)

Movement Disorder Drug Shows Promise in Mid-Stage Study

VMAT2 inhibitor improves AIMS scores (January 6)

Positive Phase III Results Reported for Oral Ferric Iron in Anemic Patients With Irritable Bowel Disease

Therapy offers alternative to IV iron treatment (January 7)

Leukemia/Lymphoma Drug Ibrutinib (Imbruvica) Meets Primary Endpoint in Phase III Study

Treatment improves progression-free survival versus ofatumumab (January 7)

Romosozumab Increases Bone Mineral Density in Mid-Stage Trial

Treatment benefits postmenopausal women (January 1)

Dry Eye Treatment Fails Late-Stage Trial

Phase III endpoints elude monoclonal antibody (December 30)

Breast Cancer Treatments Show Promise in Mid-Stage Trial

Study matches therapies to patients (December 26)

Investigational Lung Cancer Drug Disappoints in Phase II Study

Treatment shows no difference from docetaxel (December 27)

Nausea Drug Rolapitant Shows Promise in Phase III Trials

Complete response achieved in two studies (December 23)

Positive Results Reported for Sofosbuvir/Ledipasvir in Hepatitis Patients

High cure rate achieved with single-tablet regimen (December 18)

Cystic Fibrosis Drug Ivacaftor (Kalydeco) Fails to Meet Primary Endpoint in Phase III Trial

Study focuses on patients with R117H mutation (December 19)

Evolocumab Shows Promise in Long-Term Cholesterol Study

Monoclonal antibody reduces LDL-C levels (December 19)

Dabigatran (Pradaxa) Superior to Warfarin in Patients With Thrombosis or Embolism

Phase III study shows reduced bleeding (December 17)

Positive Phase II Results Reported for Brain Cancer Vaccine

Survival rate exceeds 90% at 6 months after surgery (December 16)

Positive Phase III Results Reported for Evolocumab in Patients With High Cholesterol

Study meets co-endpoints of LDL cholesterol reduction (December 17)

Positive Results Reported for Ceftolozane/Tazobactam in Intra-Abdominal Infections

Phase III trial shows noninferiority versus meropenem (December 16)

Positive Results Reported for Gout Therapy Lesinurad in Phase III Trial

Treatment reduces serum uric acid (December 13)

New Combination Therapy Fails to Delay Progression of Advanced Breast Cancer

Docetaxel/ramucirumab is equivalent to docetaxel alone (December 13)

Positive Results Reported for Aldoxorubicin in Sarcoma Patients

Phase II trial shows drug's superiority over doxorubicin (December 11)

Triple Antiviral Regimen Shows Promise Against Hepatitis C in Phase III Trial

96% of subjects achieve consistent virologic response (December 10)

Once-Daily Edoxaban Reduces VTE Recurrence Compared With Warfarin in Phase III Study

Treatment also reduces clinically relevant bleeding (December 9)

Extended-Release Topiramate Shows Promise in Late-Stage Epilepsy Trial

Treatment reduces frequency of partial-onset seizures (December 9)

Combo Asthma Drug Improves Lung Function in Phase III Study

Fluticasone furoate/vilanterol meets primary endpoint (December 6)

Depression Drug Fails Late-Stage Trials

Edivoxetine is equivalent to placebo (December 5)

Positive Phase III Results Reported for Investigational Insulin

U300 is noninferior to insulin glargine (December 3)

High-Sodium Effervescent Products Linked to Increased Heart Problems

‘Fizzy’ medications may contain harmful amounts of salt (November 26)

A Negative BRCA Test May Still Suggest Higher Breast Cancer Risk

BRCA2 gene mutation may mean a four times higher risk (November 27)

Study: Experimental Obesity Drug Does Not Increase Heart Risks

Sustained-release naltrexone/bupropion set for FDA submission (November 25)

New Blood Test Confirms Breast Cancer After Mammography

Pilot programs under way in Europe (November 25)

Antibiotic Combo Shows Promise in Treating Urinary Tract Infections

Ceftolozane/tazobactam superior to levofloxacin in phase III trial (November 25)

Positive Results Reported for Arthritis Drug Sarilumab in Phase III Trial

Treatment inhibits progression of joint damage (November 22)

Reolysin Shows Promise in Treatment of Head-and-Neck Cancers

Drug extends progression-free survival in phase III trial (November 21)

Evolocumab, an Injectable Drug, Lowers Cholesterol by 52%

New biologic found safe after 1 year (November 19)

Edoxaban Found Safer Than and as Effective as Warfarin

Positive results announced from a phase III trial (November 19)

NIH Report: Chelation Therapy Reduces Cardiovascular Events in Older Patients With Diabetes

Treatment is not currently approved by FDA (November 19)

Lomitapide (Juxtapid) Shows Promise in Treatment of Hypercholesterolemia

Positive phase III data reported at heart meeting (November 19)

Sanofi Dumps Bone Marrow Cancer Drug, Fedratinib

Risk of encephalopathy outweighs potential benefits (November 18)

Oral, Interferon-Free Hepatitis C Vaccine Shows Promise in Phase III Trial

Treatment helps 96% of patients (November 18)

Promising Phase III Data Reported for Hemophilia Drug, Eloctate

Treatment requires fewer infusions than current therapies (November 13)

Heart Disease Treatment Darapladib Fails Phase III Trial

No reduction in risk of heart attacks and strokes (November 12)

Hyperkalemia Drug Shows Promise in Phase III Trial

Data presented at annual kidney meeting (November 9)

NIH Launches Trial of Investigational Vaccine for Genital Herpes

Study will be completed in 2016 (November 8)

C1 Esterase Inhibitor (Ruconest) Shows Promise in Treating Recurrent Angioedema

FDA review set for April 2014 (November 8)

Genital Herpes Vaccine Shows Promise in Mid-Stage Trial

Viral shedding reduced after three injections (November 7)

Positive Results Reported for Leukemia Drug Obinutuzumab (Gazyva) in Phase III Study

Survival increased versus rituximab (November 7)

Patient’s Death Halts Cancer Drug Trial

Breast cancer patient succumbs to liver failure after investigational treatment (November 6)

Positive Phase III Results Reported for Vyvanse (Lisdexamfetamine) in Adults With Binge Eating Disorder

Regulatory filing expected in 2014 (November 5)

Study: Oral Hepatitis Drugs Achieve High Cure Rates

Sustained virologic response seen in 100% of patients (November 2)

HPV Vaccine Shows Promise in Phase III Trial

Immunogenicity non-inferior to that of Gardasil (November 4)

Pre-Hospital Bivalirudin Improves Outcomes Compared With Heparin in Heart Attack Patients

Death rate and major bleeding reduced (October 30)

Sustained-Release Steroid Shows Promise in Knee OA

Sustained-release triamcinolone more effective than suspension formulation (October 30)

Ovarian Cancer Drug Fails Mid-Stage Trial

No survival improvement with monoclonal antibody (October 30)

Arthritis Drug Apremilast Appears Safe, Effective in 1-Year Trials

Up to 63% of patients achieve ACR 20 at week 52 (October 28)

Tiotropium Improves Lung Function in Patients With Severe Asthma

Treatment reduces risk of severe exacerbations (October 28)

Positive 2-Year Data Reported for Simponi Aria (Golimumab) in Active RA

Nearly 70% of patients demonstrate ACR 20 response (October 28)