October 2015- Volume 11, Issue 10
October 2015
In this Issue
Clinical Trials
Time keeps on ticking
Time keeps on ticking
Cycle time reduction remains elusive, according to KMR Group’s annual cycle time trends analysis
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
ArQule presents additional clinical biomarker data from Phase 2 study of tivantinib in hepatocellular carcinoma
Advaxis’ axalimogene filolisbac shows mettle against metastatic cervical cancer
Advaxis’ axalimogene filolisbac shows mettle against metastatic cervical cancer
Advaxis’ axalimogene filolisbac shows mettle against metastatic cervical cancer
Moving forward on HIV
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
Adocia, Lilly advance BioChaperone Lispro into Phase 1b study
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
OSE reports Phase 2 results with Tedopi
OSE reports Phase 2 results with Tedopi
Company unveils clinical and immunological outcomes in patients with brain metastases
Taking time and money out of clinical trials
Taking time and money out of clinical trials
ICON and IBM plan to revolutionize clinical trial feasibility, patient recruitment and study start-up timelines
Biogen licenses Mitsubishi’s MT-1303 for autoimmune diseases
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
Preclinical
Setting the stage for development
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.
NCI grant pushes forward bone cancer research
NCI grant pushes forward bone cancer research
Though most common bone cancer in children, osteosarcoma’s rarity limits study funding
Dismantling viruses
Dismantling viruses
NanoViricides reports two successful studies of topical antiherpes treatment in animal models
Hope or hype for spinal injuries?
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
A model mouse
A model mouse
Probiodrug licenses transgenic Alzheimer’s mouse model to QPS Austria Neuropharmacology
Q&A
Q&A: Big Data for oncology
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
Editor's Focus
The price of doing drugs...er, drug development
The price of doing drugs...er, drug development
The price of doing drugs...er, drug development
Commentary
Reader discretion is advised
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
Guest Commentary: Defeating lupus starts with a diagnosis
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
MorphoSys and Immatics ally in immuno-oncology field
MorphoSys and Immatics ally in immuno-oncology field
Collaboration aims to develop novel antibody-based therapies targeting tumor-associated peptides derived from intracellular proteins
Genetic trigger for obesity discovered
Genetic trigger for obesity discovered
South Australian researchers find unexpected potential in MNK gene
Cancer answers in the South Pacific
Cancer answers in the South Pacific
Yabao Pharmaceuticals and University of South Australia collaborate on joint drug discovery laboratory.
Discovery boom in Southern California
Discovery boom in Southern California
UCSD releases news on a trio of studies that have promise for drug discovery efforts
Special Reports
Diagnostics Special Report: Non-invasion of the body snatchers
Diagnostics Special Report: Non-invasion of the body snatchers
To avoid tissue biopsy, researchers are turning to diagnostic biofluids
Diagnostics
Roche acquires GeneWEAVE
Roche acquires GeneWEAVE
GeneWEAVE’s Smarticles technology enhances Roche’s diagnostics role in fighting drug-resistant bacteria
Muddy waters for cancer detection?
Muddy waters for cancer detection?
Study of multigene panel raises questions about heredity risk of breast and ovarian cancer
A pan-Pacific partnership
A pan-Pacific partnership
Burning Rock, Illumina ink molecular diagnostics deal
Research & Development
Invoking Fitzgerald
Invoking Fitzgerald
Scripps Florida scientists’ structural discoveries could aid in better drug design
Jackson Lab launches precision genetics center
Jackson Lab launches precision genetics center
Center’s mission is to create disease models to develop therapies for life-threatening and genetically complex conditions
Inflammation intervention
Inflammation intervention
Botanisol wins NIH grant for anti-inflammatory compound that could bypass side effects of NSAIDs
Two advances in sequencing prep
Two advances in sequencing prep
Roche and Lumora make a deal and Fluidigm enhances its C1 system
Contract Services
No seven-year itch for CRO
No seven-year itch for CRO
At over $158 million, Rho nets its largest federal contract ever
Navitas introduces new regulatory process outsourcing model
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
goBalto making tracks with platform adoption
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
Contractual matters
Contractual matters
An overview of recent news on the CRO and CMO fronts
Business & Government Policy
Toward a total solution
Toward a total solution
Roche acquires Kapa Biosystems to boost next-gen sequencing product offerings
A partner for the global stage
A partner for the global stage
Apricus sends out the call for global development partner for Femprox
For your approval
For your approval
A collection of recent regulatory approvals and actions globally
On the cutting edge
On the cutting edge
A roundup of instrumentation, software and other tools and technology news
The XF factor
The XF factor
California’s Agilent to acquire Massachusetts-based Seahorse Bioscience and its assay kits for measuring cell metabolism for $235 million
