FDA accepts lixisenatide NDA for review
29 September 2015 | By Victoria White
The NDA submission for lixisenatide is based on results from the GetGoal clinical programme and includes findings from the recently-completed ELIXA study...
List view / Grid view
News
CAMO Software and Stat-Ease, Inc. release software bundle for multivariate data analysis and design of experiments
CAMO Software, leaders in multivariate data analysis software, and Stat-Ease, Inc., a leading supplier of design of experiments (DOE) software and services, have released a software bundle for multivariate data analysis and design of experiments; The Unscrambler® X Design-Expert® Upgrade...
Baricitinib superior to methotrexate in rheumatoid arthritis
Lilly and Incyte have announced positive top-line results of a Phase 3 study evaluating the safety and efficacy of baricitinib in moderately-to-severely active rheumatoid arthritis (RA).
Piramal targets the Antibody Drug Conjugates market
29 September 2015 | By Victoria White
Piramal Enterprises' Pharma Solutions division has set a target of becoming the market leader in ADCs contract commercialisation over the next five years...
Esbriet data show benefits of long-term treatment in IPF
29 September 2015 | By Victoria White
A pooled analysis from two Phase III studies showed a 38% reduction in risk of death in IPF patients who stayed on Esbriet treatment up to two years...
HRT safe and perhaps beneficial in women treated for ovarian cancer
28 September 2015 | By Victoria White
A 24-year, Phase III international trial provides the strongest evidence yet that women with epithelial ovarian cancer can safely take HRT during or after their treatment.
Ocrelizumab first medicine to show efficacy in PPMS
28 September 2015 | By Victoria White
Roche's study met its primary endpoint, showing treatment with ocrelizumab significantly reduced the progression of clinical disability...
Aspirin improves survival in gastrointestinal cancer
28 September 2015 | By Victoria White
The results of the study, involving nearly 14,000 patients, may lead to new insights regarding the use of aspirin in gastrointestinal cancer...
Ramucirumab improves progression-free survival in bladder cancer trial
28 September 2015 | By Victoria White
Median progression-free survival was 5.4 months on the ramucirumab-docetaxel arm as compared to 2.8 months for patients treated with docetaxel alone...
Verastem stops enrolment in trial of VS-6063 in mesothelioma
28 September 2015 | By Victoria White
While VS-6063 had a generally well tolerated safety profile, there was not a sufficient level of efficacy to warrant continuation of the study...
EC approves LDL cholesterol treatment Praluent
28 September 2015 | By Victoria White
Praluent is the only EC-approved PCSK9 inhibitor that is available in two starting doses, offering two levels of efficacy...
Tafinlar + Mekinist combo demonstrates overall survival benefit in melanoma
28 September 2015 | By Victoria White
The combination also demonstrated significant health-related quality of life improvements, including overall health, physical and social functioning...
AbbVie’s Viekirax approved as HCV treatment in Japan
28 September 2015 | By Victoria White
The approval provides a new interferon and ribavirin-free treatment option for patients with most common type of hepatitis in Japan...
CHMP recommends Cotellic and Zelboraf combo in advanced melanoma
25 September 2015 | By Victoria White
The CHMP’s recommendation is based primarily on results of a Phase III study that showed that people who received the combination of Cotellic and Zelboraf lived over a year without their disease worsening...
CHMP adopts positive opinion of Genvoya for HIV-1
25 September 2015 | By Victoria White
The CHMP’s recommendation will now be reviewed by the European Commission. If approved, Genvoya would be Gilead’s first single tablet regimen to contain TAF...
