September 2015- Volume 11, Issue 9
September 2015
In this Issue
Preclinical
DNA-based monoclonal antibody protects animals against dengue
DNA-based monoclonal antibody protects animals against dengue
Inovio Pharmaceuticals Inc. announced that its DNA-based monoclonal antibody (dMAb) targeting dengue virus provided protection against a lethal dengue virus challenge in mice
Preclinical progress for PLAP
Preclinical progress for PLAP
A recombinant molecule from CEVEC shows prolonged serum half-life in animal study
Summit publishes preclinical data on utrophin modulation in DMD
Summit publishes preclinical data on utrophin modulation in DMD
Data support utrophin modulation as mechanism to treat Duchenne muscular dystrophy regardless of mutation status
Moving away from animal models?
Moving away from animal models?
Group petitions FDA to change test procedures and give more weight to newer preclinical models
Scholar Rock beats drum for novel approach to disease
Scholar Rock beats drum for novel approach to disease
Innovative approach shows potential for therapeutic modulation of growth factor activation across TGFβ superfamily
Clinical Trials
Targeting TNF
Targeting TNF
Protalix’s anti-TNF fusion protein shows promising safety, biological activity in Phase 1
Looking to fill HIV vaccine void with VAC-3S
Looking to fill HIV vaccine void with VAC-3S
Clinical trial shows encouraging results for vaccine designed to prevent human immunodeficiency virus infection
Lung and lymph results for Roche
Lung and lymph results for Roche
Lung and lymph results for Roche
Third-gen TKI for lung cancer
Third-gen TKI for lung cancer
Boehringer Ingelheim enters into an exclusive license agreement with Hanmi Pharmaceutical to develop third-generation EGFR-targeted therapy
It’s ‘T’ time
It’s ‘T’ time
Adaptimmune’s TCR-engineered T cells demonstrate ‘durable persistence, tolerability’ in clinical study of multiple myeloma patients
Contract Services
PAREXEL expands model-based discovery services
PAREXEL expands model-based discovery services
Expansion of QCD group fueled by absorption of GSK pharmacology
Consolidating CROs
Consolidating CROs
Chiltern to acquire Theorem Clinical Research and become eighth-largest CRO globally
BioClinica acquires MediciGroup
BioClinica acquires MediciGroup
Adds global patient recruitment-retention engine to accelerate clinical trials
Geneuity adopts Thermo’s next- gen tech and Oncomine assay
Geneuity adopts Thermo’s next- gen tech and Oncomine assay
Company is expanding early access to Thermo Fisher technology for upcoming services to pharma customer base
Research & Development
Just a gut feeling
Just a gut feeling
BGI study finds gut and oral microbiomes relevant to early diagnosis and treatment of rheumatoid arthritis
Immune regulation with PLX
Immune regulation with PLX
Recent study sheds light on mechanism of action for Pluristem’s placenta-based MSCs
Deerfield launches $550M healthcare VC fund
Deerfield launches $550M healthcare VC fund
Fund aims to advance transformative new therapies and enable improved models for the delivery of care
Paclical goes head-to-head with Abraxane
Paclical goes head-to-head with Abraxane
Oasmia Pharmaceutical announces positive top-line results for comparison study, showing nearly identical concentration curves for both
Double-dealing in immunotherapy
Double-dealing in immunotherapy
AstraZeneca strikes pair of deals to strengthen its immunotherapy portfolio
Discovery
How do T cells cross vessel walls to reach tumors?
How do T cells cross vessel walls to reach tumors?
Findings by Roswell Park highlight central role of CXCR3 receptor and suggest options for improving immunotherapies
Getting ahead with GPCRs
Getting ahead with GPCRs
MorphoSys-Heptares deal advances as Heptares exercises option
Diabetes development team-up
Diabetes development team-up
Sanofi and Evotec join forces to develop next-generation therapies
Bicoastal discoveries from Scripps
Bicoastal discoveries from Scripps
In Florida, an antibiotic/antitumor connection; in California, a bacterial enzyme that might fight nicotine addiction
Business & Government Policy
Oh say can you see, Watson?
Oh say can you see, Watson?
IBM’s $1B acquisition of Merge Healthcare could be good news for discovery and clinical trial communities
Emulating the lung
Emulating the lung
DefiniGEN licenses lung stem cell technology from University of Cambridge
Patent Docs: Federal Circuit construes patent litigation provisions of biosimilars law
Patent Docs: Federal Circuit construes patent litigation provisions of biosimilars law
One consequence of latest interpretation may be that it becomes more difficult for reference product sponsors to identify which of their patents a biosimilar applicant may be infringing
On the cutting edge
On the cutting edge
A roundup of instrumentation, software and other tools and technology news
Diagnostics
Say ‘ahhh’ for tumor screening?
Say ‘ahhh’ for tumor screening?
Saliva and plasma testing finds head and neck tumor DNA
A leg up on multiple sclerosis (and Alzheimer’s)
A leg up on multiple sclerosis (and Alzheimer’s)
Amarantus study shows MSPrecise helps diagnose multiple sclerosis patients with 84-percent accuracy
Marrying diagnosis and treatment
Marrying diagnosis and treatment
R-Biopharm and Apogenix team up to tackle glioblastoma multiforme
Feature
Neuroscience 2015 Preview: Convening on the Lake Michigan shore
Neuroscience 2015 Preview: Convening on the Lake Michigan shore
Annual meeting of the Society for Neuroscience will tackle broad range of topics that includes traumatic brain injury, addiction, technology and aging
Q&A
Q&A: On the front lines of biodefense and more with Soligenix
Q&A: On the front lines of biodefense and more with Soligenix
DDNews recently interviewed the Soligenix’s president and CEO, Dr. Christopher J. Schaber, to find out more about what they have done and what they plan in the areas of biodefense and vaccines in particular
Commentary
Guest Commentary: Building a problem or a solution?
Guest Commentary: Building a problem or a solution?
Removing the manufacturing facility as an obstacle to commercial success in cell therapy
Out of order: When numbers fail
Out of order: When numbers fail
In our zeal to standardize healthcare and make medicine more scientific, we have to be careful not to ignore the natural variabilities of individuals within those populations
Editor's Focus
At your ‘service’
At your ‘service’
DDNews is rolling out a new section in the magazine (titled Contract Services) to cover news of the contract research and contract manufacturing sides of the pharma, biotech and diagnostics markets
