Other
Journal
News Categories
- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
- Guidelines
Clinical Trials
Long-Term Data Support Safety Profile of Dabigatran (Pradaxa) for Stroke Prevention
Major bleeding rate less than 4% per year in extension trial (June 14)
Phase III Trial Evaluates Novel Insulin Inhalation Powder for Type 2 Diabetes
Study results due this summer (June 17)
Alzheimer’s Drug Trial Halted Because of Liver Problems
Research continues on beta secretase inhibitor (June 13)
Positive Phase III Results With Tocilizumab (RoACTEMRA) in Early RA
Two studies presented at EULAR congress (June 13)
Tenofovir (Viread) Halves HIV Risk in Intravenous Drug Users
Researchers recommend pre-exposure prophylaxis (June 13)
Abatacept (Orencia) and Adalimumab (Humira) Show Comparable Efficacy in RA Patients
Two-year data reported at EULAR congress (June 11)
Positive Phase III Results With Trebananib in Recurrent Ovarian Cancer
Trebananib/paclitaxel combo improves survival versus paclitaxel alone (June 12)
Tyrosine Kinase Inhibitor Lenvatinib Shows Promise in Melanoma Patients
Lenvatinib/dacarbazine combo more effective than dacarbazine alone in phase II trial (June 10)
Extended-Release Amantadine (Nurelin) Shows Promise in Parkinson’s Disease
Drug reduces levodopa-induced dyskinesia (June 10)
Triple Compound Shows Promise in Patients With Colorectal and Head-and-Neck Cancers
Phase III data presented at ASCO meeting (June 6)
New Data Show Fingolimod (Gilenya) Helps MS Patients
Treatment improves key measures of disease (June 5)
Mixed Results Reported for Arthritis Drug Fostamatinib, Regulatory Filing Scrapped
First STK inhibitor completes phase III program (May 4)
Positive Phase III Results With Bevacizumab (Avastin) in Cervical Cancer
Survival and response rates improved versus chemotherapy alone (June 2)
Breast Cancer Drug Lapatinib (Tykerb/Tyverb) Fails Gastric Cancer Study
Overall survival similar to that of placebo (June 3)
Immunotherapy Candidate CV-301 Shows Promise in Colorectal Cancer
Treated patients have significantly better survival versus matched controls (May 29)
Teriparatide (Forteo) Increases Bone Mineral Density in Men with Glucocorticoid-Induced Osteoporosis
Treatment more effective than risedronate (May 29)
Positive Phase III Results for Extended-Release Topiramate in Epilepsy Patients
FDA review expected in December (May 22)
Positive Phase III Results With Simeprevir in Hepatitis Patients
NDA submitted for treatment of genotype 1 hepatitis C (May 21)
Positive Phase III Results With Sublingual Sufentanil in Management of Postoperative Pain
Sublingual NanoTabs reduce pain intensity in third pivotal study (May 21)
Inotuzumab ozogamicin unlikely to help survival (May 20)
Multiple Sclerosis Drug Fails Phase III Trial
Arbaclofen placarbil has no effect on spasticity (May 20)
Positive Phase III Results for Myelofibrosis Treatment
JAK2 inhibitor reduces spleen volume (May 17)
Breast Cancer Drug, EndoTAG-1, Shows Promise in Phase II Trial
Paclitaxel/lipid combo targets blood supply to tumors (May 16)
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)
New Screening Test Shows High Sensitivity in Detecting Colorectal Cancer
But precancerous sensitivity is low, disappointing investors (Apr. 18)
Positive Phase II Results With Opioid Receptor Modulator in Patients With Major Depression
Depressive symptoms significantly reduced versus placebo (Apr. 17)
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)
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)
Positive Phase II Results for Anti-Interleukin Nanobody ALX-0061 in Rheumatoid Arthritis
Up to 63% of patients achieved disease remission (Feb. 13)
Improved Survival in Phase III Trial of Sarcoma Drug Palifosfamide
Further results expected in March (Feb. 12)
Positive Phase II Results for Virus Drug Reolysin in Squamous Cell Lung Cancer
Tumor shrinkage observed in 19 of 20 patients (Feb. 8)
NIH Trial: Avastin (Bevacizumab) Improves Survival in Women With Cervical Cancer
Treated patients lived 4 months longer than nontreated patients (Feb. 7)
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)
New vaccine provides no extra protection for infants after BCG (Feb. 4)
Positive Results for Sofosbuvir in Two Phase III Hepatitis Studies
Drug meets efficacy endpoints in both trials (Feb. 4)
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)
ThermoDox (Liposomal Doxorubicin) Ineffective in Liver Cancer
Drug plus ablation fails to improve survival versus ablation alone (Jan. 31)
Tasimelteon Fails Phase IIb/III Study as Treatment for Major Depression
Circadian regulator no better than placebo at reducing symptoms (Jan. 31)
Positive Phase III Results for Obinutuzumab (GA101) in CLL Patients
Improved progression-free survival versus chlorambucil (Jan. 30)
Positive Results for Mechlorethamine Gel in Cutaneous T-Cell Lymphoma
FDA submission expected in early 2013 (Jan. 30)
Positive Phase III Results for Peginterferon in Multiple Sclerosis
Regulatory submission expected this year (Jan. 24)
Tofacitinib (Xeljanz) Slows RA Joint Damage
Disease progression reduced in patients unresponsive to methotrexate (Jan. 24)
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)
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)
Phase III Results Announced for Protease Inhibitor Simeprevir in Hepatitis C Patients
Drug achieves sustained virologic response (Dec. 20)
Research Offers New Target for Stroke Treatments
Investigators learn how blood vessels are regenerated in brain (Dec. 20)
