July 2017- Volume 13, Issue 7

In this Issue

Business & Government Policy

EMA shares meeting highlights

EMA shares meeting highlights

Focus was on Brexit preparations and development of the EU clinical trial portal and database

On the cutting edge

On the cutting edge

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

Moving fusion proteins forward

Moving fusion proteins forward

Selexis announces commercial license agreement with Takeda for the development of fusion proteins

It’s all about timing

It’s all about timing

Supreme Court rules that market announcements for biosimilars can come before approval in Sandoz v. Amgen

BIO 2017 wrap-up

BIO 2017 wrap-up

A quick look at the recent BIO International Convention and what the event offers to attendees

Clinical Trials

Recruitment in practice

Recruitment in practice

With a eye on general practitioners, Interface Clinical Research looks to reduce patient dropout rates and rescue failed trials

Novo Nordisk unveils Tresiba results

Novo Nordisk unveils Tresiba results

Diabetes therapeutic reportedly superior to insulin glargine in reducing hypoglycemia, without raising cardiovascular risk

OmniComm expands global reach with new deals

OmniComm expands global reach with new deals

TrialOne system to standardize clinical development programs, ensure regulatory compliance and bring greater operational efficiency

Good news regarding diabetes and high cholesterol

Good news regarding diabetes and high cholesterol

Sanofi and Regeneron announce positive results from first dedicated studies evaluating Praluent in individuals with diabetes and hypercholesterolemia

Contract Services

CRO consolidation

CRO consolidation

International CRO acquisition deals popular in Q2

Streamlining drug discovery

Streamlining drug discovery

Dotmatics informatics services expected to aid integrated research capabilities at Domainex

Whole greater than the sum?

Whole greater than the sum?

Two Rentschler holdings join forces for state-of-the-art biopharmaceutical development and delivery

Research & Development

OSE teams with Memorial Sloan Kettering

OSE teams with Memorial Sloan Kettering

Multiyear research collaboration focused on cytotoxic monoclonal antibody OSE-703

Hope on the horizon

Hope on the horizon

Public-private partnership teams up for trauma-related brain disorders

Bringing the data for precision medicine

Bringing the data for precision medicine

IBM and tranSMART bring tech together for translational work; tranSMART announces merger with i2b2

New options against HIV

New options against HIV

TSRI shares success in viral research and vaccine development

Preclinical

A contender against AML

A contender against AML

Partner organizations present preclinical data supporting superiority of CG’806 to fight AML

Isarna eyes glaucoma and AMD/DME treatment potential

Isarna eyes glaucoma and AMD/DME treatment potential

Preclinical results, clinical data support further exploration of ISTH0036 in several ophthalmic indications

Novel antibody drug class could mean faster arrival of immunotherapies

Novel antibody drug class could mean faster arrival of immunotherapies

Nature Medicine reports elimination of large tumors in mice by messenger rna-encoded bispecific antibodies

Repurposing research

Repurposing research

NCATS and UNR researchers use compound for experimental cancer therapy to treat muscular dystrophy

Discovery

Trying to gain on glioblastoma

Trying to gain on glioblastoma

Sweden’s Beactica and Uppsala University launch research to find a way to treat and beat brain cancer

Exscientia and Sanofi get specific with €250M deal

Exscientia and Sanofi get specific with €250M deal

Companies enter into collaboration aimed at developing bispecific small-molecule drugs

‘Artificial’ discovery

‘Artificial’ discovery

BioXcel creates new artificial intelligence company to power biotech and pharma R&D

Allergen breakthrough marks 50th anniversary

Allergen breakthrough marks 50th anniversary

Thermo Fisher Scientific celebrates the discovery of the immunoglobulin antibody, which triggered five decades of innovation in allergy and asthma diagnosis and treatment

Diagnostics

PEPperPRINT and PROGEN to develop novel RA test

PEPperPRINT and PROGEN to develop novel RA test

SeroRA antigen library will reportedly enable superior rheumatoid arthritis biomarker screening

Reading tea leaves? No, reading stools

Reading tea leaves? No, reading stools

Research by UC San Diego, Human Longevity and JCVI finds stool microbes predict advanced liver disease

Positive results for PromarkerD

Positive results for PromarkerD

Proteomics International says new blood test can detect diabetic kidney disease earlier than any other method

Feature

Show Preview: Immuno-Oncology Summit--Exploring the next generation of IO

Show Preview: Immuno-Oncology Summit--Exploring the next generation of IO

Immuno-Oncology Summit looks at how to apply new science and technology in developing effective and safe immunotherapies

Editor's Focus

Preclinical perils and clinical catastrophe

Preclinical perils and clinical catastrophe

Human-relevant non-animal models are becoming ever more relevant and ever more advanced (and thus need more attention from FDA), but they won't prevent or probably much reduce clinical trial mortality, and it's not clear that they will (or should) completely replace animal models

Commentary

Out of order: A word about communication

Out of order: A word about communication

In the vein of 'garbage in, garbage out' from the computer programming world, perhaps we also need to think in terms of 'jargon in, gibberish out' a bit more often with scientific discussions

Guest Commentary: Planning successful oncology trials amid a rapidly shifting treatment landscape

Guest Commentary: Planning successful oncology trials amid a rapidly shifting treatment landscape

When it comes to oncology clinical trials, drug developers need to stay abreast of the rapidly evolving and competitive landscape while also remaining flexible and innovative in responding to these changes
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