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Clinical Trials

Study of Lymphoma Drug Halted

Inotuzumab ozogamicin unlikely to help survival (May 20)

Positive Phase III Results With Sublingual Sufentanil in Management of Postoperative Pain

Sublingual NanoTabs reduce pain intensity in third pivotal study (May 21)

Multiple Sclerosis Drug Fails Phase III Trial

Arbaclofen placarbil has no effect on spasticity (May 20)

Breast Cancer Drug, EndoTAG-1, Shows Promise in Phase II Trial

Paclitaxel/lipid combo targets blood supply to tumors (May 16)

Positive Phase III Results for Myelofibrosis Treatment

JAK2 inhibitor reduces spleen volume (May 17)

Positive Phase III Data for New Leukemia Drug, Obinutuzumab

Disease progression, death significantly reduced versus chlorambucil (May 16)

Study: Treatment With Two Osteoporosis Drugs Better Than Either Drug Alone

Combination of denosumab and teriparatide achieves greatest increase in bone density (May 15)

Positive Phase II Results Reported for Ovarian Cancer Vaccine

Time to recurrence more than double that of standard treatment (May 15)

Alzheimer’s Drug Fails Phase III Study

Immunoglobulin no more effective than placebo (May 7)

Sublingual Sufentanil More Effective Than IV Morphine in Phase III Trial

Study finds significantly faster pain reduction (May 2)

Ofatumumab/Bendamustine Combo Shows Promise in Leukemia Patients

95% response rate in phase II trial (May 1)

Positive Phase III Results With Aclidinium/Formoterol in COPD

Regulatory filing planned for fourth quarter 2013 (May 1)

Positive Phase III Results for Pneumococcal Vaccine, Prevenar 13, in Adults

All primary and secondary endpoints met (Apr. 28)

Celecoxib (Celebrex) Meets Primary Goals in Juvenile Rheumatoid Arthritis Study

Effects on SBP and DBP similar to those of naproxen (Apr. 25)

High Response Rates Reported With Hepatitis C Vaccines in Phase II Trial

Study evaluates triple therapy plus ribavirin (Apr. 23)

Sublingual Sufentanil Shows Mixed Results in Phase II Pain Study

Higher dose meets primary endpoint, but lower dose doesn’t (Apr. 24)

Positive Phase III Results With Faldaprevir-Based Regimen in Patients with Hepatitis C

80% of patients achieve sustained viral response at 3 months (Apr. 23)

Mixed Phase II Results With Gene Therapy in Parkinson’s Disease

Treatment fails to meet primary endpoint (Apr. 19)

Non-Toxigenic C. difficile Reduces Recurrence of Infection in Phase II Trial

Recurrence rate 2% in colonized patients (Apr. 22)

Combo Therapy Improves Lung Function in Cystic Fibrosis Patients

Phase II trial evaluates VX-661 and ivacaftor (Apr. 18)

Positive Phase II Results With Opioid Receptor Modulator in Patients With Major Depression

Depressive symptoms significantly reduced versus placebo (Apr. 17)

New Screening Test Shows High Sensitivity in Detecting Colorectal Cancer

But precancerous sensitivity is low, disappointing investors (Apr. 18)

COPD Patients Benefit From Aclidinium/Formoterol in Phase III Study

Combo therapy more effective than either drug used alone (Apr. 16)

Positive Phase III Results for Dulaglutide in Type 2 Diabetes

Non-inferiority to insulin glargine demonstrated in two studies (Apr. 16)

Positive Phase II Results for Dalfampridine (Ampyra) in Stroke Patients

Drug currently indicated for improvement of walking in patients with MS (Apr. 15)

Submicron NSAIDs Reduce Acute and Chronic Pain in Phase III Trials

Data presented at two medical meetings (Apr. 11)

‘Excellent’ Outcomes Reported in NIH Trial of Lymphoma Therapy in Young People

Most patients achieve complete remission with multidrug regimen (Apr. 10)

New Clinical Data on Bortezomib (Velcade) in Multiple Myeloma

Induction therapy more effective with bortezomib than without (Apr. 7)

Positive Results Reported for Vortioxetine (Brintellix) in Adult Patients With Major Depression

Drug significantly more effective than comparator, agomelatine (Apr. 8)

Mixed Results With RA Drug Fostamatinib in Phase III Trial

Only one of two endpoints met (Apr. 5)

Positive Phase II Results With Subcutaneous Daclizumab in MS

Relapsed rate reduced by up to 54% at 1 year (Apr. 4)

Positive Phase II Results With Respiratory Virus Vaccine in Women of Childbearing Age

Vaccine candidate may have role in maternal immunization (Apr. 2)

Equivocal Results With Hepatitis C Vaccine, ChronVac-C, in Phase II Trial

Outcomes not significantly different between vaccinated and non-vaccinated subjects (Apr. 2)

Lung Cancer Drug Reolysin Meets Primary Endpoint in Phase II Trial

Patients show objective tumor response (Mar. 28)

Positive Phase II Results for Miravirsen in HCV Infection

First RNA-targeted drug to enter clinical trials (Mar. 27)

NIH Report: EDTA Chelation Therapy Modestly Reduces Cardiovascular Events

Alternative medicine not approved for heart disease in U.S. (Mar. 26)

Positive Phase III Results for Tedizolid in Severe Skin Infections

Study shows non-inferiority versus linezolid (Mar. 25)

COPD Drug Symbicort (Budesonide/ Formoterol) More Effective Than Advair (Fluticasone/Salmeterol) in ‘Real World’ Study

Disease flares and hospitalizations reduced (Mar. 19)

Hypertension Drug Aliskiren (Tekturna) Fails to Reduce Cardiovascular Deaths or Rehospitalizations

Study finds drug treatment equivalent to placebo (Mar. 20)

Positive Phase III Results for Extended-Release Budesonide (Uceris) in Ulcerative Colitis

Drug significantly more effective than placebo in inducing remission (Mar. 18)

New Data on Natalizumab (Tysabri) in Multiple Sclerosis

Relapses less likely than with IFN and glatiramer acetate (Mar. 18)

Positive Results Reported for Ferumoxytol (Feraheme) in Iron Deficiency Anemia

FDA review scheduled for October (Mar. 15)

Platinum-Free Drug Combo Provides No Survival Benefit in Cervical Cancer Patients

Data do not support replacing cisplatin with topotecan (Mar. 9)

Hormone Therapy May Help MS Patients

Chronic treatment with ACTH reduces relapse rates (Mar. 10)

Positive Phase IV Results for Ranexa (Ranolazine) in Angina Patients With Diabetes

Drug lowers angina frequency versus placebo (March 10)

Wider Use Sought for Xarelto (Rivaroxaban)

Anticoagulant drug rejected for ACS patients earlier this month (Mar. 8)

Study: Pitavastatin (Livalo) More Effective Than Pravastatin at Lowering LDL-C in HIV Patients

Dyslipidemia common with HIV infection (Mar. 7)

Positive Phase III Results for Pneumococcal Vaccine in Adults With HIV Infection

Patients show immune response to S. pneumoniae strains (Mar. 4)

Apremilast Meets Primary Endpoint in Phase III Psoriasis Trial

Drug significantly more effective than placebo in chronic plaque psoriasis (Mar. 2)

Tofacitinib (Xeljanz) Inhibits Joint Damage in Arthritis Trial

Radiographic scores significantly better versus placebo (Feb. 28)

Phase III Trial Evaluates New Irinotecan Formulation in Colorectal Cancer

Goal is progression-free survival (Feb. 28)

Brain Cancer Drug Cilengitide Fails Phase III Trial

No improvement in survival when added to standard therapy (Feb. 25)

Positive Phase III Results for Dalbavancin in Patients With Skin Infections

Antibiotic drug noninferior to vancomycin (Feb. 25)

Positive Phase III Results for Tiotropium in Asthma Patients

Drug improves lung function and reduces exacerbations (Feb. 23)

Hepatitis C Drug Sofosbuvir Meets Primary Endpoint in Phase III Trial

Treatment achieves sustained virologic response (Feb. 19)

Positive Phase II Results for Insomnia Drug Piromelatine

Significant improvements in sleep parameters versus placebo (Feb. 18)

Positive Patient-Reported Outcomes for Humira (Adalimumab) in Pediatric Crohn’s Disease

Significant improvements in health-related quality of life at 52 weeks (Feb. 15)

ASCO Meeting Features New Data on Prostate Cancer Drug Xtandi (Enzalutamide)

Treatment approved in 2012 for metastatic castration-resistant disease (Feb. 13)

Improved Survival in Phase III Trial of Sarcoma Drug Palifosfamide

Further results expected in March (Feb. 12)

Positive Phase II Results for Anti-Interleukin Nanobody ALX-0061 in Rheumatoid Arthritis

Up to 63% of patients achieved disease remission (Feb. 13)

NIH Trial: Avastin (Bevacizumab) Improves Survival in Women With Cervical Cancer

Treated patients lived 4 months longer than nontreated patients (Feb. 7)

Positive Phase II Results for Virus Drug Reolysin in Squamous Cell Lung Cancer

Tumor shrinkage observed in 19 of 20 patients (Feb. 8)

Phase III Program for Arthritis Drug Tabalumab Terminated Based on Efficacy Results

Human immunoglobulin fails to show treatment effect (Feb. 7)

Three NIH-Sponsored Trials Test Flu Treatments

Researchers seek more effective therapies (Feb. 5)

Positive Results for Sofosbuvir in Two Phase III Hepatitis Studies

Drug meets efficacy endpoints in both trials (Feb. 4)

Key TB Vaccine Trial Fails

New vaccine provides no extra protection for infants after BCG (Feb. 4)

ThermoDox (Liposomal Doxorubicin) Ineffective in Liver Cancer

Drug plus ablation fails to improve survival versus ablation alone (Jan. 31)

Study Shows Weight-Loss Drug Qsymia (Phentermine/Topiramate) Improves Cardiovascular Risk Factors

Improvements greater in patients who lost 10% or more of starting weight (Feb. 1)

Positive Phase III Results for Obinutuzumab (GA101) in CLL Patients

Improved progression-free survival versus chlorambucil (Jan. 30)

Tasimelteon Fails Phase IIb/III Study as Treatment for Major Depression

Circadian regulator no better than placebo at reducing symptoms (Jan. 31)

Positive Results for Mechlorethamine Gel in Cutaneous T-Cell Lymphoma

FDA submission expected in early 2013 (Jan. 30)

Armodafinil (Nuvigil) Fails Phase III Trial in Patients With Bipolar Disorder

Sleep drug no better than placebo as adjunct to mood stabilizers and/or atypical antipsychotics (Jan. 23)

Tofacitinib (Xeljanz) Slows RA Joint Damage

Disease progression reduced in patients unresponsive to methotrexate (Jan. 24)

Positive Phase III Results for Peginterferon in Multiple Sclerosis

Regulatory submission expected this year (Jan. 24)

Researchers Choose Solanezumab for Alzheimer’s Disease (A4) Prevention Trial

First time an amyloid-clearing drug is tested in presymptomatic patients (Jan. 18)

NIH-Supported Studies Will Focus on New Alzheimer’s Treatments

Four clinical trials to be conducted over 5 years (Jan. 14)

Research Offers New Target for Stroke Treatments

Investigators learn how blood vessels are regenerated in brain (Dec. 20)

Phase III Results Announced for Protease Inhibitor Simeprevir in Hepatitis C Patients

Drug achieves sustained virologic response (Dec. 20)

Positive Phase III Results for Gattex (Teduglutide) in Short Bowel Syndrome

Drug reduced parenteral support and number of infusion days versus placebo (Nov. 29)

Potential Drug Target May Curb Hospital-Acquired Infection

Researchers focus on intestinal C. difficile (Nov. 30)

Men With Belly Fat at Risk for Osteoporosis

Researchers link higher visceral and total abdominal fat to bone strength (Nov. 28)