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Solid but not spectacular: Victoza's weight loss verdict in non-diabetics

Fri, 24 May 2013 17:20:00 +0100

Despite reporting positive weight loss data from the third of four Phase IIIa trials from the SCALE program investigating liraglutide (Victoza) for obesity Novo Nordisk has failed to dazzle analysts who have questioned the commercial potential of the.....

Merck hit with Phase III failure for Parkinson's drug

Fri, 24 May 2013 17:20:01 +0100

Merck & Co is discontinuing development of its adenosine A2a receptor antagonist, preladenant, for Parkinson's disease (PD) after an initial review of data from three separate Phase III trials failed to provide evidence of efficacy for.....

Astellas seeks Japan approval of Xtandi

Fri, 24 May 2013 08:35:00 +0100

Following a go-ahead for marketing approval in the EU last month, Medivation's novel prostate cancer drug enzalutamide has been filed for approval in Japan by ex-US global licensee Astellas.

The once-daily oral androgen receptor.....

Astellas set for more Vesomni approvals after Netherlands nod

Thu, 23 May 2013 16:20:02 +0100

Astellas Pharma has secured marketing authorisation for its combination urology drug, Vesomni, in its first market, the Netherlands, which will now act as the reference member state for further approvals throughout Europe under the mutual recognition.....

Zensun eyes US Phase III start for first-in-class CHF drug

Thu, 23 May 2013 16:20:00 +0100

Ahead of initiating a US Phase III program for Neucardin, a novel biologic therapy for chronic heart failure (CHF), Zensun (Shanghai) Science & Technology has provided a brief glimpse at positive interim Phase II data generated in this.....

Salix to file budesonide foam NDA on Phase III success

Thu, 23 May 2013 05:20:00 +0100

Salix Pharmaceuticals plans to submit a new drug application (NDA) to the US FDA by the end of September for budesonide foam in the treatment of active mild-to-moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS) based.....

EMA accelerates Gilead HCV drug

Wed, 22 May 2013 16:20:00 +0100

Gilead Sciences hopes to launch sofosbuvir for chronic hepatitis C virus (HCV) infection in the first half of 2014 in Europe after the European Medicines Agency ( EMA) accepted the firm's marketing authorization application (MAA) for the drug, and.....

Baxter to launch HyQvia in Germany first

Wed, 22 May 2013 16:20:00 +0100

Baxter is to introduce HyQvia, a replacement therapy for adult patients with primary and secondary immunodeficiencies, in select countries in the coming weeks with further EU launches scheduled for 2014 after the European Commission granted.....

Pfizer's leading ADC in Phase III study failure

Tue, 21 May 2013 17:20:00 +0100

Pfizer's Phase III program for its leading antibody-drug conjugate drug inotuzumab ozogamicin has got off to a disappointing start after a Phase III study in one of its indications was stopped due to futility. A positive outcome from this study would.....

The acid that launched 10,000 clinical trials

Mon, 20 May 2013 16:50:00 +0100

On this day in 1747, the Scottish doctor James Lind started the first ever clinical trial – comparing possible treatments for scurvy. While serving as a surgeon aboard HMS Salisbury, he provided the first scientific evidence that.....

EMA reprieve for Bayer's Diane 35 for acne

Mon, 20 May 2013 16:20:00 +0100

Bayer's oral contraceptive, Diane 35 (cyproterone acetate plus ethinylestradiol), still offers more benefits than risks, but only if actions to minimize the risk of thromboembolism are taken, says the European Medicines Agency's Pharmacovigilance.....

XenoPort drops MS spasticity drug after PhIII flop

Mon, 20 May 2013 16:20:00 +0100

XenoPort has dropped multiple sclerosis spasticity candidate arbaclofen placarbil (AP) after a pivotal Phase III trial failed to meet its efficacy endpoints.

Santa Clara, California-based XenoPort had already suspended development of the drug.....

First positive PhIII for Novo Nordisk long-acting FIX

Mon, 20 May 2013 14:20:00 +0100

Novo Nordisk has reported positive results from the first of its three Phase III paradigm trials of the long-acting Factor IX treatment N9-GP for hemophilia B patients. The data unveiled were limited, but the company reported that the.....

Sanofi planning filings on top-line JAKARTA read-out

Mon, 20 May 2013 09:59:00 +0100

Top-line results for the Phase III JAKARTA trial of Sanofi's JAK 2 inhibitor SAR302503 have come in positive and on schedule in myelofibrosis.

Sanofi says the study met the primary endpoint, which is based on the proportion of patients.....

Promising first Phase III data for Takeda's fasiglifam

Fri, 17 May 2013 07:20:00 +0100

Takeda has released the first Phase III results for its novel antidiabetic fasiglifam (TAK-875), which show promising signs of efficacy for the first-in-class oral GPR40 agonist in a first-line setting.

Full findings from the international,.....

Dollar-a-dose rotavirus vaccine on Indian horizon

Wed, 15 May 2013 13:20:00 +0100

India has announced positive late-stage clinical results from its first indigenous oral rotavirus vaccine developed through a unique public-private partnership.

The vaccine, if approved by the national regulator, is expected to be.....

Piramal's GPR40 agonist set for US trial

Wed, 15 May 2013 01:05:00 +0100

Piramal Enterprises, the diversified Indian pharmaceuticals-to-financial services group, has received US FDA investigational new drug approval for P11187, a selective agonist of the G-protein-coupled receptor GPR40, marking new progress.....

AbbVie collaborates on celiac disease drug

Tue, 14 May 2013 22:35:00 +0100

AbbVie said it entered into a collaboration with closely held Alvine Pharmaceuticals to develop a treatment for people with celiac disease.

The agreement calls for AbbVie to pay $70 million upfront to help develop the Phase II drug......

Lilly's blood cancer drug fails in study

Mon, 13 May 2013 11:32:00 +0100

Eli Lilly & Co. said a lymphoma drug failed in a late-stage study and the company will stop development of the experimental treatment, enzastaurin.

The company plans to record a $30 million expense in the second quarter.....

CytRx abandons Phase II-stage tamibarotene for NSCLC

Fri, 10 May 2013 08:05:02 +0100

CytRx is stopping development of tamibarotene after an independent Data Safety Monitoring Committee said it was unlikely to meet its primary endpoint in a Phase IIb trial as a first-line treatment for patients with advanced non-small-cell lung cancer......