Efficacy News and Research

RSS

Pacira to present EXPAREL data in postsurgical pain at two medical meetings

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that clinical and preclinical data highlighting the safety and efficacy of EXPAREL™ will be presented at two medical meetings.

6 May 2011

Omeros' PDE7 program expands addiction franchise

Omeros Corporation today announced that its phosphodiesterase 7 inhibitors demonstrated robust efficacy in animal models of nicotine addiction.

6 May 2011

Cook Medical introduces new Formula renal stent at SCAI 2011

Patients suffering from blockages of the arteries to the kidneys now have access to a new stenting treatment option with the launch today of Cook Medical's Formula Renal Balloon-Expandable Stent at the Society for Cardiovascular Angioplasty and Intervention 2011 Scientific Sessions.

6 May 2011

COIN hosts nanobiotechnology event on nanomedicines and the regulatory path

The Center of Innovation for Nanobiotechnology (COIN) today announced the upcoming NanoBio Executive Roundtable event to be hosted at RTP Foundation in Durham, NC on May 17, 2011. This Roundtable will tackle regulatory issues surrounding nanomedicine commercialization. The “Nanomedicines and the Regulatory Path” Roundtable will kick off with a presentation from Katherine Tyner, Ph.D., a Chemist in the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA).

5 May 2011

CytRx reports $6.3 million net loss for first quarter 2011

CytRx Corporation, a biopharmaceutical company specializing in oncology, today reported financial results for the three months ended March 31, 2011, and provided a business update.

5 May 2011

Pfizer’s Revatio receives European Commission approval for pediatric treatment of pulmonary arterial hypertension

Pfizer Inc. announced that Revatio (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

5 May 2011

Over 1000 patients enrolled in world's largest ever pancreatic cancer vaccine trial

KAEL-GemVax, a leading oncology biopharmaceutical company, today announced that it had been officially notified by the independent Data Monitoring Committee that over 1000 patients have been enrolled in the TeloVac Study, making it the world's largest ever pancreatic cancer vaccine trial.

5 May 2011

S*BIO regains North American, European rights to novel JAK2 inhibitors from Onyx

S*BIO Pte Ltd today announced the restructuring of its collaboration and option agreement with Onyx Pharmaceuticals, which was entered into in January 2009.

5 May 2011

Lead investigator to discuss growing impact of AFib on US health care costs and resources

Two studies to be presented this week address the often-overlooked costs associated with atrial fibrillation, the most common form of cardiac arrhythmia.

5 May 2011

Cameron Health completes enrollment in subcutaneous implantable defibrillator pivotal study

Cameron Health, Inc. announced today that it has completed enrollment in its pivotal FDA clinical study of the S-ICD System, the world's only completely subcutaneous implantable defibrillator.

5 May 2011

Durata receives positive EMA Scientific Advice on dalbavancin clinical development plan

Durata Therapeutics today announced the Company has received positive Scientific Advice from the European Medicines Agency on the pivotal clinical development plan for dalbavancin, Durata's long-acting, intravenous lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections.

4 May 2011

Cardiac Dimensions initiates two CARILLON device trials in Functional Mitral Regurgitation

Cardiac Dimensions, Inc. announced today the initiation of two new clinical studies using the CARILLON Mitral Contour System, an investigational device for percutaneous treatment of Functional Mitral Regurgitation.

4 May 2011

AHF cautions against fast track FDA-approval for expanded use of Gilead’s Truvada

During its quarterly meeting over the weekend, The Board of Directors of the AIDS Healthcare Foundation (AHF) adopted a resolution cautioning Gilead Sciences against seeking fast track FDA-approval for the expanded use of its best selling AIDS treatment, Truvada, as a possible form of pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV.

4 May 2011

Herbal remedies commonly used in infants without efficacy & safety guarantees: Study

According to a new U.S. government study parents commonly give infants teas or herbal supplements said to soothe “fussiness” even though there's no good evidence that the products work. The market is flooded with these teas and botanical products with ingredients like chamomile, ginger and fennel that are marketed for easing infants' tummy troubles, fussiness and sleep problems. However there is no evidence that these are effective and safe.

4 May 2011

PolyMedix Phase 1B/2 clinical study data presented at ATVB meeting

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, announced that clinical data with PMX-60056 were presented at the American Heart Association's Arteriosclerosis, Thrombosis, and Vascular Biology Meeting in Chicago on April 28, 2011.

4 May 2011

pSivida presents data of ILUVIEN Phase 3 trial in Diabetic Macular Edema at ARVO 2011

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the presentation of new data from the completed 36-month FAME Study of ILUVIEN for the treatment of Diabetic Macular Edema at the 2011 ARVO Annual Meeting.

4 May 2011

CTI to re-submit pixantrone NDA to FDA's Office of New Drugs for re-review

Cell Therapeutics, today announced that the Office of New Drugs of the U.S. Food and Drug Administration after carefully reviewing the materials CTI submitted in support of its appeal, the reviews of the New Drug Application for pixantrone prepared by the FDA staff, the transcript of the March 22, 2010 Oncology Drugs Advisory Committee meeting and consulting with the Center for Drug Evaluation and Research's Deputy Director of Clinical Science and the Office of Biostatistics, concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial, provided two key matters can be satisfactorily resolved.

3 May 2011

Desirudin more effective for VTE prevention in patients with renal impairment

Desirudin reduced major venous thromboembolism and post-operative bleeding compared with the standard of care, enoxaparin, in patients with poor kidney function undergoing orthopedic surgery, according to a poster presented at the Arteriosclerosis, Thrombosis and Vascular Biology meeting.

3 May 2011

Asthma research on its way to help sufferers

The University of Newcastle is now conducting a nationwide research program to help people with asthma better control their condition. This study will be testing the effectiveness of combining antibiotics with commonly used treatments in asthmatics. This news comes today on the World Asthma Day. Statistics show that commonly prescribed treatments and medications do not relieve the symptoms for about 10 per cent of asthma patients. It's thought about 80% of people with the condition suffer numerous symptoms, yet 80% say they believe they have it under control.

3 May 2011

Boehringer Ingelheim, Eli Lilly receive FDA approval for linagliptin to treat type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today announced that the U.S. Food and Drug Administration has approved linagliptin tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

3 May 2011

Efficacy News and Research

Pacira to present EXPAREL data in postsurgical pain at two medical meetings

Omeros' PDE7 program expands addiction franchise

Cook Medical introduces new Formula renal stent at SCAI 2011

COIN hosts nanobiotechnology event on nanomedicines and the regulatory path

CytRx reports $6.3 million net loss for first quarter 2011

Pfizer’s Revatio receives European Commission approval for pediatric treatment of pulmonary arterial hypertension

Over 1000 patients enrolled in world's largest ever pancreatic cancer vaccine trial

S*BIO regains North American, European rights to novel JAK2 inhibitors from Onyx

Lead investigator to discuss growing impact of AFib on US health care costs and resources

Cameron Health completes enrollment in subcutaneous implantable defibrillator pivotal study

Durata receives positive EMA Scientific Advice on dalbavancin clinical development plan

Cardiac Dimensions initiates two CARILLON device trials in Functional Mitral Regurgitation

AHF cautions against fast track FDA-approval for expanded use of Gilead’s Truvada

Herbal remedies commonly used in infants without efficacy & safety guarantees: Study

PolyMedix Phase 1B/2 clinical study data presented at ATVB meeting

pSivida presents data of ILUVIEN Phase 3 trial in Diabetic Macular Edema at ARVO 2011

CTI to re-submit pixantrone NDA to FDA's Office of New Drugs for re-review

Desirudin more effective for VTE prevention in patients with renal impairment

Asthma research on its way to help sufferers

Boehringer Ingelheim, Eli Lilly receive FDA approval for linagliptin to treat type 2 diabetes

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Latest News