October 2015 Volume 11, Issue 10

Volume 11, Issue 10 | October 2015

October 2015

In this Issue

Clinical Trials

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Taking time and money out of clinical trials

ICON and IBM plan to revolutionize clinical trial feasibility, patient recruitment and study start-up timelines
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Biogen licenses Mitsubishi’s MT-1303 for autoimmune diseases

Potential exists for development of the therapeutic in multiple sclerosis, ulcerative colitis and Crohn’s disease
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Moving forward on HIV

CytoDyn’s PRO 140, first self-injectable treatment for HIV patients, heads to Phase 3 and could go commercial by 2017
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Adocia, Lilly advance BioChaperone Lispro into Phase 1b study

The companies will evaluate the effects of multiple daily doses of Adocia’s ultra-rapid insulin product in type 1 diabetics
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OSE reports Phase 2 results with Tedopi

Company unveils clinical and immunological outcomes in patients with brain metastases
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Time keeps on ticking

Cycle time reduction remains elusive, according to KMR Group’s annual cycle time trends analysis
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ArQule presents additional clinical biomarker data from Phase 2 study of tivantinib in hepatocellular carcinoma

ArQule presents additional clinical biomarker data from Phase 2 study of tivantinib in hepatocellular carcinoma
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Advaxis’ axalimogene filolisbac shows mettle against metastatic cervical cancer

Advaxis’ axalimogene filolisbac shows mettle against metastatic cervical cancer

Business & Government Policy

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The XF factor

California’s Agilent to acquire Massachusetts-based Seahorse Bioscience and its assay kits for measuring cell metabolism for $235 million
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Toward a total solution

Roche acquires Kapa Biosystems to boost next-gen sequencing product offerings
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A partner for the global stage

Apricus sends out the call for global development partner for Femprox
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For your approval

A collection of recent regulatory approvals and actions globally
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On the cutting edge

A roundup of instrumentation, software and other tools and technology news

Editor's Focus

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The price of doing drugs...er, drug development

The price of doing drugs...er, drug development

Commentary

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Reader discretion is advised

Differences of opinion should be part of life, but perhaps they are not allowed as much freedom anymore as they should be
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Guest Commentary: Defeating lupus starts with a diagnosis

One of the challenges at the heart of tackling systemic lupus erythematosus is the intense difficulty associated with reaching an accurate diagnosis early in the disease, and there are ways we can start doing that

Discovery

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MorphoSys and Immatics ally in immuno-oncology field

Collaboration aims to develop novel antibody-based therapies targeting tumor-associated peptides derived from intracellular proteins
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Genetic trigger for obesity discovered

South Australian researchers find unexpected potential in MNK gene
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Cancer answers in the South Pacific

Yabao Pharmaceuticals and University of South Australia collaborate on joint drug discovery laboratory.
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Discovery boom in Southern California

UCSD releases news on a trio of studies that have promise for drug discovery efforts

Research & Development

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Invoking Fitzgerald

Scripps Florida scientists’ structural discoveries could aid in better drug design
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Jackson Lab launches precision genetics center

Center’s mission is to create disease models to develop therapies for life-threatening and genetically complex conditions
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Inflammation intervention

Botanisol wins NIH grant for anti-inflammatory compound that could bypass side effects of NSAIDs
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Two advances in sequencing prep

Roche and Lumora make a deal and Fluidigm enhances its C1 system

Preclinical

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NCI grant pushes forward bone cancer research

Though most common bone cancer in children, osteosarcoma’s rarity limits study funding
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Dismantling viruses

NanoViricides reports two successful studies of topical antiherpes treatment in animal models
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Hope or hype for spinal injuries?

Asterias announces preclinical data supporting the safety and use of AST-OPC1 as a treatment for spinal cord injury
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A model mouse

Probiodrug licenses transgenic Alzheimer’s mouse model to QPS Austria Neuropharmacology
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Setting the stage for development

Rounding up some recent news of preclinical studies and results around the world A quartet of brief stories to give you a quick peek across the globe (a few select portions, anyway) into what researchers have turned up in preclinical efforts in recent months.

Special Reports

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Diagnostics Special Report: Non-invasion of the body snatchers

To avoid tissue biopsy, researchers are turning to diagnostic biofluids

Diagnostics

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Roche acquires GeneWEAVE

GeneWEAVE’s Smarticles technology enhances Roche’s diagnostics role in fighting drug-resistant bacteria
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Muddy waters for cancer detection?

Study of multigene panel raises questions about heredity risk of breast and ovarian cancer
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A pan-Pacific partnership

Burning Rock, Illumina ink molecular diagnostics deal

Contract Services

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No seven-year itch for CRO

At over $158 million, Rho nets its largest federal contract ever
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Navitas introduces new regulatory process outsourcing model

Move is driven in large part by pressure on pharmas and biotechs to do more regulatory work even as budgets tighten
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goBalto making tracks with platform adoption

More than 2,000 CROs and pharma firms now employ the company’s Activate software-as-a-service application
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Contractual matters

An overview of recent news on the CRO and CMO fronts

Q&A

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Q&A: Big Data for oncology

Oncology Research Information Exchange Network could make huge steps to bring together oncology research, oncology patients and drug developers
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