February 2016- Volume 12, Issue 2

February 2016

In this Issue

Diagnostics

Delving into dark matter

Delving into dark matter

Non-coding RNA molecules in cancer cells trigger immune response because of pathogen-like features

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

Discovery

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

Betting on bispecifics

Betting on bispecifics

F-star, AbbVie link up to develop bispecific antibodies

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

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

Clinical Trials

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

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

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

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

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

Commentary

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

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

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

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

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
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