December 2016- Volume 12, Issue 12

December 2016

In this Issue

Business & Government Policy

On the cutting edge

On the cutting edge

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

Improving FDA metrics and ‘quality culture’

Improving FDA metrics and ‘quality culture’

CPhI Worldwide experts propose new FDA quality metrics system and recommend critical formulation attributes

Partnering for production

Partnering for production

Horizon announces bioproduction outlicense deal with unnamed partner

Commenting on Cures

Commenting on Cures

What are some of the life-sciences players saying about 21st Century Cures?

Research & Development

New research into NR

New research into NR

ChromaDex says nicotinamide riboside is essential to cellular energy production

Two-pronged response

Two-pronged response

MIT advancement in immunotherapy fights cancer in mice

Lipid profiling steps up a notch

Lipid profiling steps up a notch

Multi-lipid profiling highlighted as potential new pathway for COPD biomarker development

ADI-PEG 20 can boost antitumor immune surveillance

ADI-PEG 20 can boost antitumor immune surveillance

Findings suggest that ADI-PEG 20 could potentially enhance the activity of antitumor immune therapies, including checkpoint inhibitors

PrOCTOR prediction

PrOCTOR prediction

‘Moneyball’ approach may help predict new drug toxicity in humans

Diagnostics

Making a case for Vectra

Making a case for Vectra

Crescendo highlights poster data at rheumatology meeting for its multi-biomarker blood test

Epic uncovers prostate cancer biomarker

Epic uncovers prostate cancer biomarker

Liquid biopsy test matches patients to metastatic prostate cancer treatment

NSCLC stratification

NSCLC stratification

Biodesix’s VeriStrat proves capable of identifying patients who will respond to EGFR-TKI therapy

Clinical Trials

Aduro reports on mesothelioma trial

Aduro reports on mesothelioma trial

Research shows promising results on the use of CRS- 207

New disease findings and old clinical trials

New disease findings and old clinical trials

Study supports using amyloid inhibitors to treat Alzheimer’s disease

PS promise in cancer

PS promise in cancer

Peregrine preclinical studies support a combo approach being studied in clinical trials

Novel antiepileptic for Dravet syndrome

Novel antiepileptic for Dravet syndrome

New extended release formulation and preclinical data set stage for Phase 1b Trial to start in mid-2017

A deluge of data

A deluge of data

Past quarter saw Boehringer Ingelheim release results for multiple trials in pulmonary, oncology areas

Contract Services

Strengthening clinical research sites

Strengthening clinical research sites

INC Research unveils Catalyst Community and Catalyst Site Network at Global Site Solutions Summit

Massing in Massachusetts

Massing in Massachusetts

Neopharm joins Boston-area research cluster with the acquisition of Averica

Envigo’s new program to aid drug R&D

Envigo’s new program to aid drug R&D

Focus shifts to new and developing tech not involving the direct use of animals

Preclinical

Onxeo announces promising potential for Beleodaq

Onxeo announces promising potential for Beleodaq

Combining agent with checkpoint inhibitors expands therapeutic possibilities for tumor treatment

Cutting the fat to treat cancer

Cutting the fat to treat cancer

Salk Institute researchers and collaborators develop novel cancer treatment that halts fat synthesis in cells, stunting tumor growth

Healing ahead with Hsp60?

Healing ahead with Hsp60?

A topical treatment of the protein heals wounds in diabetic mice in just three weeks

Discovery

Growing interest in IP6K1

Growing interest in IP6K1

TSRI studies show the protein is a promising target for treating obesity, diabetes

New findings about cytomegalovirus

New findings about cytomegalovirus

Research into CPEB1 protein may offer hope for new therapies to fight CMV infection

As simple as ADC

As simple as ADC

Swiss-based NBE and Czech Republic’s SOTIO sign license deal for next-gen ADCs in oncology

Amyris achieves key milestone in major drug discovery collaboration

Amyris achieves key milestone in major drug discovery collaboration

Company’s µPharm technology platform delivers initial development work in just four months for new oncology drug development

Chemical tags on RNA silence female X chromosome

Chemical tags on RNA silence female X chromosome

Findings could lead to new treatments of Rett syndrome and other X-linked chromosomal female diseases

Editor's Focus

‘21st Century Curse’ in the making?

‘21st Century Curse’ in the making?

The U.S. Congress actually passed the 21st Century Cures Act in both houses, but while there are very bright spots in the legislation, it remains uncertain if it will be a mostly good move in the end

Commentary

The next big thing

The next big thing

We have increasing noise out there as we make more advances, and picking up the actual signals is becoming harder and harder; maybe it's time to consider slowing down a little and increasing ambiguity

Guest Commentary: The Science of cell culture--Maintaining phenotypic and genotypic heterogeneity

Guest Commentary: The Science of cell culture--Maintaining phenotypic and genotypic heterogeneity

Through periodic testing and proper cell culture management, misidentified and contaminated cell lines can be identified before publication of results or release into the scientific community, thus protecting the validity of research results and the credibility of the biomedical community as a whole

Special Reports

Q&A

Q&A: Solosec’s trajectory among antibiotics

Q&A: Solosec’s trajectory among antibiotics

Robert Jacks, president and chief financial officer of Symbiomix, discusses briefly the company’s product Solosec (secnidazole), a next-generation 5-nitroimidazole antibiotic
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