News

Sanofi-backed virtual trial gets green light in Europe

A Sanofi-backed consortium has won clearance to run a virtual diabetes trial in Europe. The regulatory nod reportedly marks the first time European authorities have green-lit a clinical trial with full electronic informed consent.

RainDance Technologies opens patent suit against 10X Genomics

The suit alleges that 10X Genomics--which exited stealth mode and raised $55.5 million last month--is using tech protected by patents licensed to RainDance from the University of Chicago.

Microsoft, Cambridge University team up on blood cancer simulation model

Researchers have created a computer model to simulate blood cell development. The model can simulate the activity of genes tied to blood cancers, giving researchers a quick way to map the pathways that play out in leukemia and other diseases.

Medidata's wearables wish list: Long battery life and water resistance

Medidata has struck a deal with Garmin to offer its clients the use of vívofit activity trackers in clinical trials. The choice of vívofit gives an indication of the characteristics clinical trial sponsors may prioritize as wearables start to take off in research.

Ex-J&J exec turns to crowd to fund brain disorder simulation project

The former head of Johnson & Johnson's initiative to develop stratified drugs for Alzheimer's disease is trying to crowdfund the development of computer simulations of brain disorders. Magali Haas is seeking $299,900 for the project, which builds on a multiple sclerosis prediction model created by her nonprofit, Orion Bionetworks.

Novo Nordisk green lights IPO of IT services unit

Novo Nordisk has decided to go ahead with the long-discussed IPO of its IT services unit NNIT. The Danish drugmaker spent the past year weighing up the merits of a public listing, which analysts have speculated could value the company at anywhere from $460 million to $1.2 billion.

TrialReach raises $13.5M for clinical trial-patient matching service

TrialReach raised $13.5 million in a Series B round to scale up its clinical trial discovery platform. The system is designed to accelerate enrollment into clinical research by matching patients to appropriate trials.

Medidata posts 50% jump in partial SDV clients as risk-based monitoring takes off

The long-awaited move toward risk-based monitoring has started. Having introduced its partial source document verification (PSDV) offering back in 2010, Medidata has now reported a 50% year-on-year jump in the number of clients using the technology.

Apple edges ahead of Google in race to become a health data repository

Apple has begun staking its claim to be the de facto standard for remote data collection. The tech giant has reportedly kicked off pilot programs of its HealthKit service at many leading hospitals, positioning it to play a major role in remote patient monitoring for general care and clinical trials.

Merck joins Novartis, Pfizer on tech-enabled protein consortium with $6M buy-in

Merck has joined Novartis, Pfizer and a host of other Big Pharma companies in the Structural Genomics Consortium (SGC), a transatlantic public-private collaboration focused on the 3-D structures of proteins.

FDA seeks budget boost for precision medicine IT infrastructure

The FDA has requested $2 million in President Obama's 2016 budget to build precision medicine-related IT infrastructure. The regulator highlighted cloud computing and data security as areas in which it needs to improve.

Report: Public Big Data initiatives need moral framework to succeed

Big Data initiatives such as President Obama's precision medicine program and the United Kingdom's 100,000 Genomes Project risk losing public trust unless they consider the moral and legal implications of their work, a report has warned.

Obama puts giant database at the heart of precision medicine plan

President Obama has made the creation of a huge, technically challenging database the centerpiece of his precision medicine proposal. The initiative will draw on existing resources and new studies to gather data on the biology, behavior and health of more than 1 million people.

21st Century Cures Act lays out vision for sharing health data with R&D

The U.S. House of Representatives' Energy and Commerce Committee's Subcommittee on Health has laid out its vision for the future of drug and device regulation in a draft bipartisan bill. And the plan has significant implications for the use of health data in R&D and other topics related to biotech IT.

Duke moves into new digs to support Google Baseline collaboration

Duke University has expanded its presence on the North Carolina Research Campus to support its work with Google and other partners.

Alexion enlists BioXcel for data dive in search of next Soliris

Alexion Pharmaceuticals has turned to Big Data specialist BioXcel for help identifying its next blockbuster rare disease drug. BioXcel is applying its rare disease database to the collaboration, which aims to figure out which indications are most likely to benefit from various therapeutics.

Biogen taps Google's data analytics skills for MS research

The Google X lab that spawned smart contact lenses and self-driving cars is teaming up with Biogen Idec to unravel patient-to-patient variation in the progression of multiple sclerosis.

AstraZeneca strikes deal with Box as IT revamp continues

Box has added a big-name client just days after pulling off a $175 million IPO. The deal sees AstraZeneca join Allergan and Eli Lilly on the list of major biopharma companies that use Box's cloud content sharing and collaboration tools.

EMA posts guide to help IT teams with its new pharmacovigilance database

The European Medicines Agency (EMA) has taken another step toward the creation of a database of all suspected adverse reactions reported within its jurisdiction. The EMA laid out the technical details of the system and how it will affect biopharma companies in a 100-page guide it published this week.

Analyst: FDA guidance will slow near-term adoption of wearables

Juniper Research analyst James Moar told Outsourcing-Pharma the placing of limits on the types of information that can have medical uses will slow uptake.