February 2016- Volume 12, Issue 2
February 2016
In this Issue
Business & Government Policy
The toxicity challenge
The toxicity challenge
Current HTS assays may miss chemicals that are metabolized to a more toxic form; government agencies are encouraging solutions
10 by 2018
10 by 2018
Spark unveils vision of having 10 clinical-stage gene therapy programs by 2018, including one commercial and two in pivotal trials
On the cutting edge
On the cutting edge
A roundup of instrumentation, software and other tools and technology news
$32 billion for Baxalta
$32 billion for Baxalta
Shire, Baxalta to combine in deal set to create largest rare diseases company
Clinical Trials
New data on colorectal cancer
New data on colorectal cancer
XBiotech reports additional positive data from Phase 3 European trial of Xilonix in advanced colorectal cancer
Evaluating eltoprazine
Evaluating eltoprazine
Amarantus reports positive Phase 2 data for eltoprazine to treat Alzheimer’s aggression
Heart smart
Heart smart
iCardiac to take part in Cardiac Safety Research Consortium validation program
Discovery
Betting on bispecifics
Betting on bispecifics
F-star, AbbVie link up to develop bispecific antibodies
A new kind of periodic table
A new kind of periodic table
U.K. researchers present Periodic Table of Protein Complexes to better understand and predict proteins
Active on improving trials
Active on improving trials
ACRES, ActivMed partner for quality and sustainability of clinical research sites
A ‘gold mine’ of drug targets for autism
A ‘gold mine’ of drug targets for autism
UCLA researchers explore uncharted territory in brain cells with mutated genes previously tied to autism
Preclinical
Hep B functionally cured in AIC649 animal studies
Hep B functionally cured in AIC649 animal studies
Compound in combination therapy induces natural immune response to hepatitis B virus
Partnering against pertussis
Partnering against pertussis
University of Texas teams with Synthetic Biologics to develop whooping cough treatment
Restoring sight in achromatopsia
Restoring sight in achromatopsia
Preclinical data evaluating cone-specific promoters further validate company’s technology
Rising out of the ASH
Rising out of the ASH
Immune Design and bluebird bio share preclinical oncology data from annual hematology meeting
Diagnostics
Illumina’s GRAIL
Illumina’s GRAIL
Sequencing leader launches new company for early cancer detection via blood-based screening
Cancer confirmation
Cancer confirmation
California-based MDxHealth says positive data support expanded diagnostic test for prostate cancer
Fighting HPV to fight cancer
Fighting HPV to fight cancer
Genticel to evaluate Roche HPV test in preparation for Phase 3 program of GTL001
PerkinElmer acquires Vanadis Diagnostics
PerkinElmer acquires Vanadis Diagnostics
PerkinElmer acquires Vanadis Diagnostics
Delving into dark matter
Delving into dark matter
Non-coding RNA molecules in cancer cells trigger immune response because of pathogen-like features
Research & Development
Shank3 side effects
Shank3 side effects
Neuroscientists unravel gene’s role in autism and schizophrenia
Simplifying single-cell efforts
Simplifying single-cell efforts
Bio-Rad and Illumina partner on single-cell genomics solution
A LEAP forward for autism
A LEAP forward for autism
The EU-AIMS LEAP study gains EMA support for its biomarkers, study criteria
Addressing chronic inflammatory and degenerative diseases
Addressing chronic inflammatory and degenerative diseases
Fibrocell and Intrexon to develop treatment for arthritis and related conditions through targeted, long-term therapeutic delivery
Sanofi and Innate Pharma collaborate in immuno-oncology
Sanofi and Innate Pharma collaborate in immuno-oncology
The companies will apply Innate Pharma’s proprietary technology to develop innovative bispecific antibody formats engaging natural killer cells
Contract Services
CRO growth
CRO growth
Charles River Labs acquires Germany-based CRO Oncotest GmbH for $36 million, broadens oncology pipeline
Pairing with Paragon
Pairing with Paragon
IAVI contracts with Paragon Bioservices to develop and manufacture an HIV vaccine candidate
Crown Bioscience holds symposium; expands in Asia-Pacific region
Crown Bioscience holds symposium; expands in Asia-Pacific region
Symposium focused on precision medicine and translating oncology drug discovery into clinical success
Q&A
Q&A: SCILEX pursues responsible pain management
Q&A: SCILEX pursues responsible pain management
DDNews speaks with Anthony Mack of SCILEX Pharmaceuticals on the management of pain
Feature
Show Preview: Molecular Med Tri-Con--Visit the preeminent event on molecular medicine
Show Preview: Molecular Med Tri-Con--Visit the preeminent event on molecular medicine
Molecular Medicine Tri-Conference wiill be held in San Francisco and attract several thousand people from several dozen nations to learn about molecular medicine from the angles of diagnostics, genomics, cancer and informatics
Editor's Focus
Get off the fence, FDA, and deal with generic labeling
Get off the fence, FDA, and deal with generic labeling
The FDA did good last year with approvals of novel new drugs and of therapeutics for rare diseases, but it seems to be slacking on updates to generic labeling rules
Commentary
R&D: Risk and delivery in different cultures
R&D: Risk and delivery in different cultures
The worlds of academia and business view each other with jaundiced eyes at times, but both add value to the research process
Market insight: Prescription medicines-- Costs in context
Market insight: Prescription medicines-- Costs in context
The pharma and biotech sectors are significant drivers within the U.S. economy and huge contributors to funding and employment in the R&D sector overall
News Briefs
Valneva signs new R&D collaboration with GlaxoSmithKline for the EB66 cell line
Valneva signs new R&D collaboration with GlaxoSmithKline for the EB66 cell line
Valneva to supply process development services for EB66-based influenza vaccines–Advanced Development program sponsored by the U.S. Department of Health and Human Services—Valneva to receive research fees under the new agreement
Patent News
Scope of safe harbor provisions of Hatch-Waxman Act still unclear
Scope of safe harbor provisions of Hatch-Waxman Act still unclear
A recent decision provides another example of the court setting forth the contours of the scope of the safe harbor, particularly with regard to activities performed by a generic drug maker to ensure quality control and other aspects of drug making post approval
