Theorem Clinical Research

Global News

Lilly’s CYRAMZA phase III colorectal cancer trial meets primary endpoint

Friday, September 12, 2014 01:35 PM

Eli Lilly has announced that the RAISE trial, a phase III study of ramucirumab (CYRAMZA) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting.

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Gates Foundation commits $50M to support emergency response to Ebola

Friday, September 12, 2014 01:13 PM

The Bill & Melinda Gates Foundation plans to commit $50 million to support the scale up of emergency efforts to contain the Ebola outbreak in West Africa and interrupt transmission of the virus.

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Report: Research indicates mangos may lower blood sugar in obese adults

Friday, September 12, 2014 01:08 PM

Regular consumption of mango by obese adults may lower blood sugar levels and does not negatively impact body weight, according to research published in the journal Nutrition and Metabolic Insights. These are important findings considering that approximately 34% of U.S. adults have been classified as obese and given the health concerns related to obesity, such as type 2 diabetes (T2DM) and metabolic syndrome.

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Evotec, CHDI Foundation extend ongoing Huntington's disease collaboration

Friday, September 12, 2014 01:00 PM

The CHDI Foundation, a U.S. privately-funded nonprofit biomedical research organization, has extended and restated its collaboration with Evotec, a drug discovery solutions company based in Germany, through 2017. The collaboration, which aims to find new treatments for Huntington's disease, an inherited neurodegenerative disorder, means CHDI will fund up to 52 full-time scientists at Evotec over the next three years.

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SRI International, Nobelpharma partner on endometriosis treatment

Thursday, September 11, 2014 01:41 PM

SRI International, a California-based independent nonprofit research institute, and Nobelpharma, a Japanese pharmaceutical company, have entered into a licensing agreement to test SR16234, an SRI drug candidate that may be effective in treating endometriosis. SR16234 is a member of a class of drugs known as selective estrogen receptor modulators (SERMs) that regulate the effects of the hormone estrogen.

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Medidata, Icon partner to bring efficiencies to ePRO

Thursday, September 11, 2014 01:40 PM

Medidata, a NewYork-based global provider of cloud-based solutions for clinical research in life sciences, and global CRO Icon have formed a joint initiative designed to bring new efficiencies to the administration of electronic patient-reported outcomes (ePROs) in clinical trials. The new offering provides sponsors with an ePRO solution that reduces costs, saves time and enhances patient engagement.

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Report: Psoriatic arthritis market will reach more than $3.5B in 2023

Thursday, September 11, 2014 01:28 PM

The market for psoriatic arthritis (PsA) therapies will grow nearly 66%, increasing to $3.7 billion in 2023, due to the continued uptake of premium-price biologics and novel therapies expected to launch during the 2013 to 2023 forecast period, according to Burlington, Mass.-based Decision Resources Group.

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Seattle Genetics, Genmab enter into antibody-drug conjugate collaboration

Thursday, September 11, 2014 01:20 PM

Seattle Genetics, a biotech company focused on development and commercialization of innovative antibody-based therapies for cancer, and Genmab, a Denmark-based international biotech company specializing in differentiated human antibody therapeutics for cancer, have entered into an additional antibody-drug conjugate (ADC) collaboration.

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Almac’s releases clinical supply chain management service

Wednesday, September 10, 2014 03:02 PM

Almac, a contract development and manufacturing organization headquartered in Craigavon, Northern Ireland, has released a new clinical Supply Chain Management (SCM) service as a response to growth in demand for biologics and global trials.

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NeuroVive Pharmaceutical, Oncore Biopharma ink $150M agreement

Wednesday, September 10, 2014 03:01 PM

NeuroVive Pharmaceutical, a Swedish mitochondrial medicine company, has signed an exclusive global out-licensing agreement with the Pennsylvania-based OnCore BioPharma for the development and commercialization of NeuroVive’s drug candidate NVP018 for oral treatment of chronic hepatitis B virus (HBV) infection. The agreement could give NeuroVive a total of $150 million in conditional milestone payments, plus royalties on future drug sales.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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