May 2018- Volume 14, Issue 5
In this Issue
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
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
On the cutting edge
On the cutting edge
A roundup of instrumentation, software and other tools and technology news
Making progress: A roundup of recent pharma/biotech milestones
Making progress: A roundup of recent pharma/biotech milestones
News from AiCuris, Organovo, Catalyst Biosciences and Zosano Pharma
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
Research & Development
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
Clathrin collaboration
Clathrin collaboration
Microscopy shows how cells engulf nutrients and viruses
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
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
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
Clinical Trials
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
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
Berubicin blasts glioblastoma
Berubicin blasts glioblastoma
The anthracycline drug is the only one of its class engineered to attack tumor cells at the site
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
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
Feature
ISSCR 2018 show preview: Heading Down Under to bring up matters about stem cells
ISSCR 2018 show preview: Heading Down Under to bring up matters about stem cells
International Society for Stem Cell Research’s 2018 annual meeting to be hosted in Australia
ASCO 2018 show preview: Deep dish--ASCO brings cancer researchers to Chicago
ASCO 2018 show preview: Deep dish--ASCO brings cancer researchers to Chicago
Annual clinical cancer research meeting dives deep into discovery
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
Special Report on Epigenetics: More than a number
Special Report on Epigenetics: More than a number
Epigenetics shows that not all aging is created equal
