DIA Biosimilars 2013

Clinical Intelligence

Merck to continue development of Tecemotide in phase III trial

Tuesday, October 1, 2013 10:30 AM

Merck Serono, the biopharmaceutical division of Merck, has decided to continue clinical development of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide  (also known as L-BLP25 and formerly known as Stimuvax). Merck Serono, which is developing tecemotide under a license agreement with Oncothyreon, will conduct a new phase III trial called START2 for patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).

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Cenduit: Now with Patient Reminders

Caris Life Sciences study reports positive results for evidence-guided tumor profiling

Tuesday, October 1, 2013 10:00 AM

Caris Life Sciences, a biosciences company focused on personalized medicine, has announced data from two studies which demonstrate the potential of evidence-guided tumor profiling to immediately improve the treatment of patients with hard-to-treat cancers, including cancers of unknown primary (CUP) and rarer and refractory cancers.

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CRF Health – eCOA Forum

The CenterWatch Monthly, October 2013

Tuesday, October 1, 2013 09:00 AM

New growth and decline in Asia clinical trials

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X-Chem achieves milestones, licenses drug discovery programs to AstraZeneca

Wednesday, September 25, 2013 02:43 PM

X-Chem, a privately-held biotechnology company focused on applying its drug discovery capabilities to the generation of novel small molecule therapeutics, has achieved several milestones leading to the licensing of three drug discovery programs by AstraZeneca, in the context of a collaboration the companies established in May 2012.

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KaloBios publishes KB001 phase I study results

Monday, September 23, 2013 01:33 PM

KaloBios Pharmaceuticals has published phase I study results for KB001, a first-generation, anti-Pseudomonas aeruginosa (Pa) type III secretion system (TTSS) antibody for use in patients with cystic fibrosis (CF). Data from this initial single-dose clinical study support the continuation of KaloBios' ongoing phase II study of KB001-A, a second-generation, anti-TTSS antibody in CF patients with chronic Pa infections.

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NIH awards $33m grant to Banner Alzheimer's Institute, study planned

Friday, September 20, 2013 11:14 AM

Banner Alzheimer's Institute (BAI) has announced a major prevention trial to evaluate a treatment in cognitively healthy older adults at the highest known genetic risk for developing Alzheimer's disease at older ages. An NIH grant, expected to total $33.2 million, will support this research.

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Boehringer Ingelheim collaborates with Presidio Pharmaceuticals

Monday, September 16, 2013 03:12 PM

Boehringer Ingelheim has completed patient enrollment for a phase IIa clinical trial (NCT01859962) investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection. This trial is conducted in collaboration with Presidio Pharmaceuticals and evaluates Boehringer Ingelheim’s investigational compounds, the protease inhibitor faldaprevir (BI 201335) and non-nucleoside NS5B polymerase inhibitor, deleobuvir (BI 207127), in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.

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Analysis highlights predictive biomarkers discovery for Vectibix

Monday, September 16, 2013 03:11 PM

Amgen has published a biomarker analysis of Vectibix (panitumumab) in combination with FOLFOX, a type of oxaliplatin-based chemotherapy, for the first-line treatment of patients with metastatic colorectal cancer (mCRC). Published in the New England Journal of Medicine, the analysis found that RAS mutations, beyond the known KRAS exon 2 mutations, predict lack of response to Vectibix in combination with FOLFOX. RAS mutations are mutations occurring in exons 2, 3 and 4 of KRAS and NRAS.

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Camurus receives milestone from Novartis

Monday, September 16, 2013 08:45 AM

Novartis has exercised its option to acquire an exclusive license for the further development and worldwide commercialization of CAM2029 for treatment of patients with acromegaly and neuroendocrine tumors (NETs). The license also covers additional future products based on the Camurus' FluidCrystal Injection depot technology. Camurus is a research-based pharmaceutical company dedicated to developing therapeutics for diseases with high unmet medical needs.

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Study concludes Stretta is desirable GERD treatment

Tuesday, September 10, 2013 01:00 PM

A newly published peer-review study that examines Stretta therapy is bringing renewed attention to this non-surgical procedure that has 10 years of patient data and recently earned The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) highest GRADE recommendation.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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