May 2018- Volume 14, Issue 5

In this Issue

Q&A

Q&A: A new option for oral anticoagulants

Q&A: A new option for oral anticoagulants

A chat with Espero BioPharma’s CEO reveals shortcomings of current standard of care and efforts to advance a better candidate

Business & Government Policy

Patent Docs: Federal Circuit suggests way out of subject matter eligibility morass

Patent Docs: Federal Circuit suggests way out of subject matter eligibility morass

A tortured path on applying patent eligibility decisions finally offers some scant hope for better interpretation and understanding

On the cutting edge

On the cutting edge

A roundup of instrumentation, software and other tools and technology news

Predictive genomic medicine

Predictive genomic medicine

NIH project aims to determine phenotype from genotype, match researchers to genes and variants of interest

Novartis takes aim at SMA market with AveXis deal

Novartis takes aim at SMA market with AveXis deal

Company is acquiring AveXis and its spinal muscular atrophy drug candidate for $8.7 billion

NDA Group releases data comparing FDA and EMA

NDA Group releases data comparing FDA and EMA

Information released ahead of annual DIA Europe meeting in Basel

Clinical Trials

Positive results for novel antiviral in HBV

Positive results for novel antiviral in HBV

Assembly Biosciences to launch Phase 2a studies in summer 2018

Seladelpar impresses at International Liver Congress

Seladelpar impresses at International Liver Congress

CymaBay’s PPARδ agonist reduces alkaline phosphatase levels in PBC patients

Getting you where you need to go

Getting you where you need to go

ClinOne announces integration with Lyft and Uber for free patient transportation to study sites

A setback, but not for long

A setback, but not for long

Serlopitant misses primary and secondary efficacy endpoints, but Menlo continues with development program
Berubicin blasts glioblastoma

Berubicin blasts glioblastoma

Berubicin blasts glioblastoma

The anthracycline drug is the only one of its class engineered to attack tumor cells at the site

Diagnostics

Multiple studies show potential of T2’s diagnostics

Multiple studies show potential of T2’s diagnostics

Data indicate improved detection of sepsis-causing pathogens over blood culture-based diagnostics

Sample-to-insight pathogen testing improves

Sample-to-insight pathogen testing improves

QIAGEN acquires molecular diagnostics company STAT-Dx and its multiplex technologies

A 'FIGHT' for life in gastric cancer

A 'FIGHT' for life in gastric cancer

PGDx to develop companion diagnostic for Five Prime’s bemarituzumab

Illumina, Loxo and companions

Illumina, Loxo and companions

Deal expands Illumina’s oncology offerings for with a CDx version of TruSight Tumor 170 for solid tumors

Discovery

TSRI makes headway in neurology

TSRI makes headway in neurology

Two new discoveries have been made regarding Parkinson’s disease and depression

A new arrow in the treatment quiver

A new arrow in the treatment quiver

Boosting adenosine levels with a new stem cell population could help to treat epilepsy

C4XD signs license deal with Indivior for addiction program

C4XD signs license deal with Indivior for addiction program

Company receives $10 million up front, with potential milestones totaling $284 million plus royalties

BioAscent establishes integrated drug discovery services offering

BioAscent establishes integrated drug discovery services offering

New CSO hired to lead company’s extended capabilities in medicinal chemistry and in-vitro biosciences

Gems in the ‘junk’

Gems in the ‘junk’

Noncoding mutations found to be a major mechanism in cancer

Research & Development

Clathrin collaboration

Clathrin collaboration

Microscopy shows how cells engulf nutrients and viruses

Roswell Park data may link ovarian and testicular cancer

Roswell Park data may link ovarian and testicular cancer

Men with testicular cancer more likely to have female relatives with ovarian cancer

TSRI arm gets $34M from NIH

TSRI arm gets $34M from NIH

Scripps Translational Science Institute receives NIH Clinical and Translational Science Award

Agilent and BioTek join forces

Agilent and BioTek join forces

Companies create an integrated metabolic analysis and imaging platform

The chip craze continues

The chip craze continues

Research teams worldwide are working to harness the potential of organ-on-a-chip technology

Preclinical

Repair and regeneration

Repair and regeneration

Cell therapy study offers hope for Duchenne muscular dystrophy

Rhythm licenses RM-853 from Takeda

Rhythm licenses RM-853 from Takeda

Oral GOAT inhibitor complements and expands efforts in Prader-Willi syndrome

‘Tremendous potential’ against pancreatic cancer

‘Tremendous potential’ against pancreatic cancer

Combination of immune agonists may fight one of the fastest-moving and deadliest of cancers

THR-149 shows efficacy vs. DME

THR-149 shows efficacy vs. DME

ThromboGenics announces publication of preclinical data in The Journal of Medicinal Chemistry

Contract Services

Frontage acquires Concord Biosciences

Frontage acquires Concord Biosciences

Deal will add preclinical, toxicology and agrochemical services to Frontage’s existing product development portfolio

Boosting and complementing its DMPK

Boosting and complementing its DMPK

International CRO gobbles up drug transporter and drug-drug interaction specialist company

Helsinn wins across the board

Helsinn wins across the board

Company takes first in all core categories at 2018 CMO Leadership Awards

Feature

Special Focus on CRISPR: Regarding lipids and CRISPR

Special Focus on CRISPR: Regarding lipids and CRISPR

On one side, the gene-editing technology tackles lipids; on the other, it uses them for transportation; plus additional news of CRISPR research and technology and a bonus guest commentary

Special Reports

Editor's Focus

Editor’s focus: Navigating the gray areas

Editor’s focus: Navigating the gray areas

Gray literature isn't the same as peer-reviewed literature, but it doesn't need to be; however, we need to keep use of it in perspective and in balance

Commentary

Out of order: What lies beneath

Out of order: What lies beneath

Randomized, double-blinded, placebo-controlled clinical trials are the "gold standard" but let's remember that even gold can be tarnished and not all that glitters is truly gold

Guest commentary: Implications of cGMP for CRISPR/Cas9 cellular therapy

Guest commentary: Implications of cGMP for CRISPR/Cas9 cellular therapy

CRISPR/Cas9 offers the hope of a cure for various maladies, including genetic diseases and cancers, but current Good Manufacturing Practices still matter in handling this therapeutic avenue
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