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Headlines > Clinical Development

Cromos launches cardiology-based site research organization in Russia

03-Mar-2015 - Moscow-based Cromos Pharma, an international full-service CRO, has launched Cardiorus, a cardiology and cardiothoracic surgery site research organization (SRO), with its clinical base being at the Bakoulev Center of Cardiovascular Surgery...

Sponsors look to cut overhead costs, reduce timelines with ‘lean’ outsourcing models

02-Mar-2015 - As pipelines dwindle in a post-blockbuster world, pharma and biotech R&D operations are looking for new ways to take on non-traditional product development strategies that allow for less internal resources...

Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

27-Feb-2015 - The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publicly accessible database of clinical trial data does not do enough to make...

Senators reintroduce bill to offer CROs a share of R&D tax credit

27-Feb-2015 - Sens. Tom Carper (D-Del.) and Pat Toomey (R-Penn.) reintroduced a bill that would permanently allow CROs (contract research organizations) to capture a share of the R&D tax credit. ...

India taking further steps to reform clinical trial industry

27-Feb-2015 - Fluctuations in regulations over the past few years have reduced the number of clinical trials run on the subcontinent, but now governing bodies are looking at new ways to attract...

Academics urge updating WHO, ICH guidelines to ensure quality drugs used in clinical trials

26-Feb-2015 - The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from...

Outsourcing market’s recently IPO'd stock prices see early spike

26-Feb-2015 - Between May 2013, when Quintiles went public , and this week, newly public companies’ stocks in the biopharma outsourcing space have all seen their prices rise by more than 35%.

Icon posts solid quarterly results, sees stock rise 10%

26-Feb-2015 - Dublin-based CRO Icon saw its quarterly net revenue, backlog and income rise over the same quarter last year, all of which helped to boost its stock by about 10% on Wednesday.

INC sees strong quarterly book-to-bill, more diverse customer base

25-Feb-2015 - Following its recent IPO , INC Research delivered double-digit net service revenue growth for the year and further diversified its customer base when compared with previous years.

Transcelerate teams to take on investigator selection bias

24-Feb-2015 - A register of clinical investigators can help eliminate bias according to Big Pharma Group Transcelerate, which has teamed with DrugDev to develop such a database.

LabCorp to operate under two segments following $5.7bn Covance merger

24-Feb-2015 - The integration of Covance and LabCorp is beginning with the announcement that LabCorp will operate under two distinct segments: LabCorp Diagnostics and Covance Drug Development, LabCorp CEO Dave King said...

AstraZeneca R&D arm signs five-year deal with NIST to advance discovery, manufacturing

23-Feb-2015 - MedImmune, the biologics R&D arm of AstraZeneca, and the US National Institute of Standards and Technology (NIST) have signed a five-year agreement to support research that will help advance drug...

Amended Chinese GCP could aid development of CRO industry

20-Feb-2015 - The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part...

PRA upbeat on first earnings report, projects modest growth for 2015

20-Feb-2015 - In its first earnings call since launching its IPO (initial public offering) in November , PRA Health Sciences reported consistent growth over last year.

News in brief

Covance shareholders sign off on LabCorp merger

19-Feb-2015 - CRO Covance's stockholders voted Wednesday to adopt the previously announced $6.1bn merger agreement providing for the acquisition of Covance by LabCorp at the special meeting of Covance stockholders. 

Parexel expands its clinical trial site network to speed drug development

19-Feb-2015 - CRO Parexel on Wednesday announced the expansion of its clinical trial site alliance network, which includes investigator sites and Site Management Organizations (SMOs) that help the company quickly access and...

WuXi borrows $165m from Asian banks for M&A deals in 2015

18-Feb-2015 - China-based CRO WuXi PharmaTech has entered into a syndicated loan facility to borrow up to $165m from a consortium of banks in Asia to seek out new acquisitions. ...

Orphan drug boom comes with a steady stream of outsourcing

17-Feb-2015 - With the FDA approving a record number of orphan drugs in 2014, sponsors weren’t the only ones to reap profits from their development.

inVentiv ups early phase offering with new clinic in Miami

16-Feb-2015 - CRO inVentiv Health announced late last week new plans to open a Phase I/IIA clinic in Miami, thereby expanding its early phase clinical services to the US.

US FDA working to make clinical trials less wasteful

16-Feb-2015 - The US FDA is looking to set up master protocols that can continuously run and help cut down on waste that’s prevalent in the clinical trial industry, Director of FDA's...

Quintiles CEO questions how smaller CROs will compete moving forward

13-Feb-2015 - As the world’s largest CRO continues to snap up market share, CEO Tom Pike is questioning how smaller CROs will compete given the expertise and geographical breadth of their larger...

News in brief

Inoviem raises €500k in seed funding

12-Feb-2015 - CRO Inoviem Scientific has raised €500,000 ($566,000) in seed funding with Cap Innov’Est. 

No GVK Bioscience trialled drugs under EMA spotlight are sold in Switzerland says Swissmedic

12-Feb-2015 - None of the drugs the EMA wants suspended over concerns about data manipulation at GVK Biosciences are sold in Switzerland says Swissmedic.

Study finds lax clinical practices uncovered by FDA not reflected in peer-reviewed literature

11-Feb-2015 - US FDA inspections that uncover significant departures from good clinical practice are seldom included in peer-reviewed literature, according to a new study published in JAMA’s Internal Medicine . 

LabCorp looks to settle lawsuit seeking to block Covance acquisition

11-Feb-2015 - LabCorp has agreed to settle a lawsuit that aimed to derail the company’s $6.1bn acquisition of CRO Covance .

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