March 2017- Volume 13, Issue 3

In this Issue

Business & Government Policy

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

NIH expands its ENCODE project

NIH expands its ENCODE project

The expansion will focus on increasing the project’s catalog and characterizing its contents

Celgene offers up to $775M for Delinia

Celgene offers up to $775M for Delinia

The biotech acquisition boosts Celgene’s inflammation and immunology pipeline

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

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

Diagnostics

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

Demonstrating prognostic power

Demonstrating prognostic power

Myriad Genetics’ EndoPredict test gets early support from doctors for predicting recurrence of breast cancer

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

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

Discovery

Key drug target

Key drug target

Scientists solve structure of CCR9 chemokine receptor

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

Growing pains

Growing pains

IU research connects fruit fly growth with cancer cell development

Contract Services

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

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

Bracket forms new SAB subcommittee

Bracket forms new SAB subcommittee

New entity focused on Alzheimer’s disease holds inaugural meeting at CTAD 2016

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

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

Commentary

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

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

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
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