March 2017- Volume 13, Issue 3
In this Issue
Diagnostics
Demonstrating prognostic power
Demonstrating prognostic power
Myriad Genetics’ EndoPredict test gets early support from doctors for predicting recurrence of breast cancer
Predicting therapeutic benefit
Predicting therapeutic benefit
Nuclear localization of protein can change course of prostate cancer therapy
A Michigan match-up
A Michigan match-up
Zomedica to explore the use of Celsee’s human CTC test on canines
Serious plans for Series B
Serious plans for Series B
GRAIL expects nearly $1B in financing and plans to fund test development and repurchase Illumina stake
Business & Government Policy
NIH expands its ENCODE project
NIH expands its ENCODE project
The expansion will focus on increasing the project’s catalog and characterizing its contents
Broad Institute wins CRISPR patent rights (for now)
Broad Institute wins CRISPR patent rights (for now)
Fierce legal tussle over who owns the rights to genome-editing technology fails to go in favor University of California
On the cutting edge
On the cutting edge
A roundup of instrumentation, software and other tools and technology news
Sanquin and Synthon enter oncology deal
Sanquin and Synthon enter oncology deal
Exclusive global deal revolves around immuno-oncology therapeutic leads that modulate the CD47-SIRPα pathway
For your approval
For your approval
A collection of recent regulatory approvals and other actions globally
Patent Docs: FDA releases further guidances for its biosimilar drug approval pathway
Patent Docs: FDA releases further guidances for its biosimilar drug approval pathway
While provisional and still subject to revision, the trio of new guidances are beneficial in providing a starting point for the further development of the biosimilar pathway and lowering the cost of biologic drugs in the United States
Celgene offers up to $775M for Delinia
Celgene offers up to $775M for Delinia
The biotech acquisition boosts Celgene’s inflammation and immunology pipeline
Clinical Trials
Neurological news on multiple fronts
Neurological news on multiple fronts
MediciNova’s MN-166 could treat drug addiction, progressive multiple sclerosis and pain
A pair to test against lung cancer
A pair to test against lung cancer
Boehringer Ingelheim launches Phase 2 combo trial of afatinib in combination with pembrolizumab for patients with SqCC of the lung
GBM data goes to print
GBM data goes to print
Results from Diffusion’s Phase 1/2 trial of trans sodium crocetinate published in Journal of Neurosurgery
CPF and Cardiff University announce study of tefinostat
CPF and Cardiff University announce study of tefinostat
Phase 2 MONOCLE trial commences for orphan drug intended to treat chronic myelomonocytic leukemia
Out of the starting gate
Out of the starting gate
A roundup of clinical trial startups and initial breakthroughs
Discovery
Unlocking ligands
Unlocking ligands
New TSRI ligand method could turbocharge drug discovery, protein research
Understanding USP9
Understanding USP9
New potential Alzheimer’s target found to influence tau activity
Key drug target
Key drug target
Scientists solve structure of CCR9 chemokine receptor
Growing pains
Growing pains
IU research connects fruit fly growth with cancer cell development
Contract Services
INC named CRO for Phase 2 trial of CLR 131
INC named CRO for Phase 2 trial of CLR 131
Cellectar Biosciences chooses INC Research to handle hematologic malignancies clinical trial, boosted by NCI grant
Bracket forms new SAB subcommittee
Bracket forms new SAB subcommittee
New entity focused on Alzheimer’s disease holds inaugural meeting at CTAD 2016
New peptide tests possible due to recently announced partnership
New peptide tests possible due to recently announced partnership
SymCel and Colzyx will explore ability of 25 different new collagen VI-derived antimicrobial peptides to kill bacteria
Vetter starts operations at Ravensburg Vetter West
Vetter starts operations at Ravensburg Vetter West
Site enlargement enables increased capacity for state-of-the-art quality control and storage
Research & Development
Some ‘Wellcome’ funding for new antibiotics
Some ‘Wellcome’ funding for new antibiotics
Polyphor receives award from Wellcome Trust to advance OMPTA class against resistant infections
A growing GENE Consortium
A growing GENE Consortium
Intellia Therapeutics joins Genomics England’s industry initiative for the 100,000 Genomes Project
Validation trials to explore promise for organoids
Validation trials to explore promise for organoids
Organoids will be used in experimental drug research, with an original focus on cystic fibrosis
Nemus Bioscience teams up with UM
Nemus Bioscience teams up with UM
Research agreement will focus on advancing NB2111, an analogue of cannabidiol
Preclinical
Novel combination for HBV
Novel combination for HBV
Spring Bank and Arbutus Biopharma agree to preclinical collaboration for chronic hepatitis B
Is gemcabene a ‘gem’ in fatty liver effort?
Is gemcabene a ‘gem’ in fatty liver effort?
Gemphire to launch Phase 2 trial for the investigational compound, a potential new treatment for NAFLD/NASH
A new indication for GR-MD-02
A new indication for GR-MD-02
Galectin expands from fibrosis to explore drug in cancer
Positive preclinical data for Catalyst’s coagulation factors VIIa and IX
Positive preclinical data for Catalyst’s coagulation factors VIIa and IX
Next-gen coagulation factors demonstrate performance sufficient to support initiation of clinical studies in hemophilia B
Feature
AACR 2017 Preview: Trying to focus on everything
AACR 2017 Preview: Trying to focus on everything
The AACR annual meeting can’t cover everything, but it may be as close as you can get in one place this year
Special Focus on Nonalcoholic Steatohepatitis: NASH is coming on strong, but so is the response of researchers
Special Focus on Nonalcoholic Steatohepatitis: NASH is coming on strong, but so is the response of researchers
The liver disease poses a growing threat to many, but also an opportunity for pharmas and biotechs to fill a gaping void
Editor's Focus
Recurring themes around these parts
Recurring themes around these parts
A tour around some of the things that seem to be on an increasing number of minds lately, and thus showing up increasingly in DDNews
Commentary
Out of order: Reproduci-bull?
Out of order: Reproduci-bull?
When it comes to the challenges of reproducibility in research these days, we all stand to suffer if we don’t address some of the systemic issues opening the door to rot
Guest Commentary: Assessing the state of liquid biopsy and its future path
Guest Commentary: Assessing the state of liquid biopsy and its future path
Precision medicine must be the wave of the future, and liquid biopsies are poised to be part of this in predicting the prognosis and monitoring the clinical outcome of metastatic cancer patients
