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EMA re-confirms drug suspensions due to faulty trial data from GVK Biosciences

25-May-2015 - Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical...

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Amarantus selects Chiltern for Phase IIb study

22-May-2015 - Neurologically-focused biotech Amarantus BioScience has entered into a clinical trial agreement with CRO Chiltern to manage the clinical research and monitoring program services for the Phase IIb study of eltoprazine...

inVentiv expands NIS services to help stem confusion on new EU trials regulation

22-May-2015 - inVentiv Health has expanded its compliance products and services to assist biopharma companies conducting non-interventional studies (NIS). 

House introduces companion bill to offer CROs a share of R&D tax credit

22-May-2015 - In a House bill that largely mirrors one reintroduced earlier this year in the Senate, CROs (contract research organizations) would be able to capture a share of the R&D tax...

FDA offers ‘encouraging’ draft guidance for adaptive device trials, expert says

21-May-2015 - Adaptive clinical trial designs can be used in medical device studies as long as they are for “prospectively planned modifications based on accumulating study data without undermining the trial’s integrity...

Antiquated clinical trial industry ripe for change from innovation, experts say

15-May-2015 - Experts across the sponsor-CRO spectrum seem to agree on at least one thing: the clinical trial process is ready for a major transformation, though how quickly and what types of...

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Quintiles refinances, adds $1.95bn in secured credit facilities

15-May-2015 - Quintiles has completed its previously announced refinancing in which it entered into new senior secured credit facilities totaling $1.95bn, consisting of a $500m revolving credit facility and $1.45bn of term...

Japanese trials sector heating up says PPD

15-May-2015 - Western CROs with a presence in Japan are benefiting from growing demand from international pharma and local drugmakers interested contractors with global reach says PPD.

Tigermed Envy? WuXi may be eyeing a launch on Shenzhen exchange

14-May-2015 - With WuXi pushing full steam ahead in its bid to go private, one expert says that the company may be envious of a competing CRO -- Hangzhou Tigermed, which is...

Re-engineering clinical trials: A 'tipping point' vs. incremental change

13-May-2015 - The debate continues over how to optimize clinical trials, with some experts calling for incremental changes to combat inefficiencies while the FDA’s deputy commissioner says the industry is at a...

EMA: clinical data may not be needed for topical comparisons

13-May-2015 - The EMA (European Medicines Agency) is changing the way it assesses quality of topical drugs for marketing authorisations.

Upfront data analysis can improve study of protocol feasibility, expert says

12-May-2015 - Analyzing data on previous study performance and the complexity and design of a trial can offer earlier insights on whether a protocol is feasible, Michelle Marlborough, VP of product strategy...

GSK, UNC-Chapel Hill partner to accelerate search for HIV cure

11-May-2015 - The University of North Carolina at Chapel Hill and GlaxoSmithKline (GSK) are creating a new HIV research center and a jointly owned new company that will focus on discovering a...

PRA off to a ‘strong start’ in 2015

08-May-2015 - CRO PRA Health Sciences saw its Q1 revenue climb about 10% on a constant currency basis compared to the same quarter last year.

Quintiles opens a new bioanalytical lab in the Netherlands

06-May-2015 - Wasting no time in furthering its lab-based JV with Quest Diagnostics  the world’s largest CRO Quintiles has opened a GLP-compliant bioanalytical liquid chromatography-mass spectrometry (LC-MS) laboratory in Oss, the Netherlands....

Canadian CRO pushes into India with Max Neeman acquisition

06-May-2015 - Montreal-based CRO JSS Medical Research has completed its acquisition of New Delhi, India-based CRO Max Neeman International for $1.5m.

Biocon's CRO Syngene launches IPO following record quarter

05-May-2015 - Indian CRO Syngene has reported a record quarter as it gets set to spin-out from its parent company Biocon.

Researchers call for further ethical discussions of adaptive clinical trials

04-May-2015 - Despite a growing interest in adaptive clinical trial (ACT) designs, few designs have been used relative to the overall number of trials conducted, and more ethical concerns need to be...

Roundup of CRO partnerships, offerings and other news

04-May-2015 - A number of small, mid-sized and large CROs (contract research organizations) and other companies tied to the world of clinical research have announced various partnerships and other financial moves over...

Parexel sees modest quarterly growth as backlog rises by nearly $1bn

01-May-2015 - Although Parexel’s consolidated service revenue increased by only 2% for the quarter, the company reported that its backlog included gross new business wins of $942.4m, which was 5.3% higher than...

Draft US House bill sets up a host of new clinical trial provisions

01-May-2015 - With the aim of getting new drugs to patients more quickly, a new House draft bill released Wednesday offers a whole set of new ideas around what the NIH and...

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WuXi receives bid to take it private

30-Apr-2015 - China-based contract research and manufacturing company WuXi PharmaTech has received a proposal to be taken private by a consortium led by its CEO and Ally Bridge Group Capital Partners.

FDA’s Woodcock calls to cut clinical costs via new efficiencies

30-Apr-2015 - As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier this week that there...

Quintiles acquisitions start to pay off in Q1

30-Apr-2015 - CRO Quintiles’ recent purchases of oncology and medical device specialist Novella and EHR service firm Encore Health Resources are starting to reap new benefits for the world’s largest CRO, the...


Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 - Sponsors can license biosimilars for multiple indications without performing clinical studies for each area, the EMA and FDA agree.

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