January 2014- Volume 10, Issue 1
January 2014
In this Issue
Preclinical
Instem shows support for SEND
Instem shows support for SEND
Proper management of SEND information helps sponsors, CROs and regulators to share and analyze study data
Getting fired up over FynomAbs
Getting fired up over FynomAbs
Covagen has announced the expansion of its research collaboration with Tanabe Research Laboratories USA Inc., a fully owned subsidiary of Mitsubishi Tanabe Pharma Corp.
Inovio hopeful about potential MERS vaccine
Inovio hopeful about potential MERS vaccine
No vaccine currently exists for disease that so far has demonstrated a 42-percent fatality rate
Zurich team explores immunotherapy for brain tumors
Zurich team explores immunotherapy for brain tumors
Promising new approach emerges as researchers combine two compounds in preclinical studies
Project A.L.S. announces research effort with Lilly
Project A.L.S. announces research effort with Lilly
Pair will look to study cancer drugs that might treat devastating brain disease
Business & Government Policy
NIH green-lights first batch of Alzheimer’s genomic data
NIH green-lights first batch of Alzheimer’s genomic data
Data release includes genome sequences from 410 people in 89 families
FDA overstepping its bounds?
FDA overstepping its bounds?
Agency under some fire for ordering 23andMe to shut down consumer genetic tests
Patent Docs: Patent-eligible subject matter in the district courts
Patent Docs: Patent-eligible subject matter in the district courts
Last month, in a decision by the Northern District of California in Ariosa Diagnostics v. Sequenom, the court granted summary judgment of invalidity for claims directed to non-invasive prenatal diagnosis
Highlights from the pipeline
Highlights from the pipeline
Thomson Reuters highlights third quarter’s promising drugs to watch
Research & Development
An oncological group effort
An oncological group effort
GlaxoSmithKline (GSK) has launched a global consortium consisting of itself and six internationally renowned comprehensive cancer centers based in the United States, Canada and Europe to collaborate on a scientific research network aimed at focusing on oncology clinical trials and combination drug therapies, as well as translational research
The ‘real thing’ in cancer modeling
The ‘real thing’ in cancer modeling
Trevigen gets NIH SBIR contract to develop system that mimics body physiology
Biogen Idec and Proteostasis forge $200M+ neurodegenerative pact
Biogen Idec and Proteostasis forge $200M+ neurodegenerative pact
R&D effort will focus on candidates to inhibit Usp14, for Alzheimer’s disease and other conditions
Bayer picks up Algeta for $2.9 billion
Bayer picks up Algeta for $2.9 billion
Looking at potentially billions in milestone and royalty payments, Bayer makes a move to buy its Xofigo partner outright
Discovery
Define and regulate
Define and regulate
Conference assesses discovery challenges and other issues related to nanomedicines
Versant Ventures expands into Canada
Versant Ventures expands into Canada
U.S.-based firm to invest in innovative, early-stage drug discovery and accelerate commercialization of scientific research
Going social for Alzheimer’s research
Going social for Alzheimer’s research
Growing network gives small biotech and academia better access to CROs
New ALS impact from ImStar
New ALS impact from ImStar
ImStar’s lead candidate derived from withaferin A targets TANA inflammation pathway
Roche and Molecular Partners ally against cancer
Roche and Molecular Partners ally against cancer
Partnership will combine novel biologics with drug-conjugate technology
Diagnostics
Gaining GI ground with Given Imaging
Gaining GI ground with Given Imaging
Covidien to acquire developer of PillCam, an optical capsule endoscope
Choosing controls
Choosing controls
ATCC discusses trends and controls in molecular applications at AMP meeting
‘Personalizing’ NGS tools
‘Personalizing’ NGS tools
Cerner and Claritas Genomics will collaborate to advance personalized medicine
Pinning down prostate cancer
Pinning down prostate cancer
Vanderbilt University and University of Alberta identify prostate cancer biomarker that may predict patient outcomes
Clinical Trials
Antibiotic innovation
Antibiotic innovation
Helperby Therapeutics and Cadila Pharmaceuticals collaborate on ‘resistance breaker’ R&D agreement
SINE compound shows promise in blood malignancies
SINE compound shows promise in blood malignancies
Karyopharm data for first-in-class Selinexor shows effectiveness in Phase 1 study
Intra-Cellular Therapies goes after schizophrenia
Intra-Cellular Therapies goes after schizophrenia
Company announces positive topline Phase 2 results for ITI-007
Jump-starting immunotherapies with Juno
Jump-starting immunotherapies with Juno
Fred Hutchinson, Memorial Sloan-Kettering, Seattle’s Children launch new company with $120M investment
Blood cancer compounds boding well
Blood cancer compounds boding well
Novartis announces positive results for cancer compounds for multiple myeloma, leukemia
Special Reports
Medicating metabolism
Medicating metabolism
Novel approaches are expanding the focus on both prominent and rare metabolic disorders
Editor's Focus
Warp speed ahead with the new DDNews
Warp speed ahead with the new DDNews
The magazine's new chief editor gives you a brief introduction to himself but mostly offers a tour around the new format because in 2014, instead of news sections based on therapeutic, technological and research areas, our sections will be based on the pipeline stages that most of you deal with in your day-to-day work.
Commentary
OUT OF ORDER: Taking a global view
OUT OF ORDER: Taking a global view
As DDNews Feature Editor Randy Willis notes, he and several others have harped over the years that the needs and practical realities of patients in the developing world are significantly different from those in the developed world. While that statement may sound patently obvious and therefore ridiculous, it has significant implications when it comes to delivering useful and sustainable healthcare, and he tells you why.
Commentary: Federal Circuit enforces written description requirement even for negative limitations and narrower clai
Commentary: Federal Circuit enforces written description requirement even for negative limitations and narrower clai
In two recent decisions, different panels of the Federal Circuit reaffirmed the importance of the written description requirement of 35 U.S.C. § 112(a). These cases underscore the importance of the written-description requirement, and suggest that the Federal Circuit may be inclined to reject as invalid broad claims covering solutions to problems not described in the patent.
Q&A
‘Breathing life’ into analytical data
‘Breathing life’ into analytical data
A Q&A with Ryan Sasaki, director of global strategy at ACD/Labs, and Steve Thomas, an investigator at GlaxoSmithKline
