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Headlines > Clinical Development

Europe bans drugs tested by GVK; FDA monitors but keeps allowing sales

31-Aug-2015 - The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.

Mid-sized M&A madness: Smaller deals dominate CRO space so far in 2015

27-Aug-2015 - Chiltern’s takeover of Theorem Clinical will be the latest acquisition in a busy eight months of deals impacting the mid-sized CRO space.

Duke University selects Greenphire's trial participant payment card

26-Aug-2015 - Duke University has selected a debit card-based payment system from Greenphire to pay clinical trial participants in over 3,000 studies per year.

Covance deal expansion with "top-tier" customer bodes well for LabCorp says analyst

25-Aug-2015 - Covance has announced a contract expansion with one of its existing customers signing a multi-year deal to use the CROs trial optimization tech for lab monitoring.

Major INC Research investor sells shares for $177m

20-Aug-2015 - INC Research investor Avista Capital Partners has offloaded shares just days after the CRO was upgraded by a number of analysts.

Coalition unveils new standardized MRI protocol for brain tumor clinical trials

18-Aug-2015 - The Jumpstarting Brain Tumor Drug Development Coalition (JBTDDC) is offering a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials to help in the assessment of...

WuXi to go private as part of $3.3bn deal

17-Aug-2015 - A group of investors, shareholders and executives of China-based CDMO WuXi are taking the company private in a deal worth about $3.3bn.

Accelovance to add 70 clinical research jobs at Welsh site

14-Aug-2015 - CRO (contract research organization) Accelovance has accepted a grant from the government of Wales and will open a new site in Swansea with 70 new employees.

Site Specific Research Organization partners with Isis Pharmaceuticals on Phase II trial

14-Aug-2015 - The completion of the Phase II study of Isis Pharmaceuticals’ novel antisense drug, volanesorsen, in treating patients suffering from hypertriglyceridemia included a collaborative effort between Isis and CTMG, which claims...

Evotec raises guidance as its service business offers ‘strong basis’ for future growth

13-Aug-2015 - With a flurry of recent deals tied to Sanofi and a string of other collaborations, Germany’s Evotec is seeing a steep rise in revenues from its contract research division and...

Medpace’s European expansion continues in UK

11-Aug-2015 - CRO Medpace has tripled the size of its Stirling, Scotland office with a new office, also in Stirling, that will allow for growth in data management, biostatistics, quality assurance, regulatory...

Indian CRO hit with FDA warning letter over two specific violations

11-Aug-2015 - Indian contract testing company Sipra Labs has received a warning letter  from the US FDA over issues with the company's validation of test methods and failure to investigate out of specification test...

Evotec expands its Sanofi alliance with new $330m diabetes drug development deal

10-Aug-2015 - Hamburg, Germany-based Evotec and Sanofi are launching a strategic collaboration in diabetes drug development that could be worth as much as $330m (€303m) for the German company, including €3m upfront.

Parexel looks to accelerate margin growth with low-cost labor

07-Aug-2015 - CRO Parexel’s staffing numbers took center stage during its earnings call Thursday as the company re-iterated plans to lay off as many as 850 employees – mostly in higher-cost countries...

iCardiac acquires clinical trials division of nSpire Health

07-Aug-2015 - Cardiac safety assessment service provider iCardiac Technologies has added respiratory and ePRO services to its offerings through the acquisition of the clinical trials division of nSpire Health.

CRO consolidation: Chiltern to acquire Theorem Clinical Research

07-Aug-2015 - Mid-size CROs (contract research organizations) are banding together once again, this time with Chiltern on Thursday signing a purchase agreement to acquire Theorem Clinical Research.

Indian government suspends EU trade talks over spat with GVK Biosciences

06-Aug-2015 - The Government of India will now defer EU trade negotiations as part of its effort to support local CRO GVK Biosciences, which was accused of data manipulation by the EMA...

Lilly ends Alzheimer’s study contract with UCSD as California judge steps in

06-Aug-2015 - Eli Lilly on Tuesday cut ties with the University of California, San Diego (UCSD) as a legal battle between UCSD and the University of Southern California (USC) continues over the control of...

Trial Transparency

Positive RCTs drop to 8% under transparency regulations

06-Aug-2015 - Only eight percent of published clinical trials show positive drug results following new transparency standards, a sample study shows.

INC Research preps for secondary offering of 8m shares

05-Aug-2015 - Nine months since its IPO, a group of shareholders of CRO (contract research organization) INC Research common stock are looking to sell off 8m shares, according to an SEC filing .

Australia looks to speed clinical trial start-up times

04-Aug-2015 - Australia’s National Health and Medical Research Council (NHMRC) is getting pragmatic with increasingly long clinical trial timelines and is now looking to streamline the research governance process in order to...

News in brief

Novartis' Mereo selects Icon as exclusive provider of development services

04-Aug-2015 - Mereo BioPharma Group, a recently-formed  specialty biopharma company, has selected CRO (contract research organization) Icon as its sole provider of clinical development services. 

Quintiles announces secondary public offering of about $545m worth of stock

03-Aug-2015 - CRO Quintiles on Friday announced the pricing of a secondary public offering of 7,000,000 shares of its common stock at a price to the public of $77.85 per share, which...

China’s FDA calls for verification data on clinical trials

03-Aug-2015 - Late last month the China Food and Drug Administration (CFDA) began mandating that drug registration applicants self-inspect and verify clinical data to ensure that it’s authentic and reliable.

UPDATE

Parexel to lay off up to 125 transferred GSK employees

03-Aug-2015 - Beginning Sept. 30, Massachusetts-based CRO (contract research organization) Parexel will lay off as many as 125 of the 450 employees it brought on from GlaxoSmithKline (GSK) in North Carolina late last...

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