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Headlines > Clinical Development

Do mid-size CROs have business model problems? One CEO thinks so

21-Oct-2014 - Squeezed by the pressure of shorter deadlines and higher quality expectations, as well as by competition from larger peers, mid-size CROs may need to think more about innovation to stay...

Parexel pushes further into UK with new grants, Nottingham office

21-Oct-2014 - Little more than a week after purchasing the UK RTSM provider ClinIntel , Parexel has secured new office space in Nottingham, UK and won grants totalling £1m ($1.6m). 

Sellas signs up PPD as a preferred partner

21-Oct-2014 - Swiss-based Sellas Life Sciences Group has signed a definitive master service agreement with CRO Pharmaceutical Product Development (PPD) to advance and expand clinical and regulatory development.

ISI Group gets behind Quintiles while downgrading Pfizer's strategic partners ICON and Parexel

15-Oct-2014 - The investment bank ISI Group has selected Quintiles as its preferred CRO while concurrently downgrading Pfizer’s strategic partners Parexel and ICON .

INC Research preps to jump on the IPO bandwagon with SEC filing

07-Oct-2014 - Following pushes to go public by top peers, CRO INC Research has filed an S-1 with the SEC in preparation for an IPO (initial public offering) on the NASDAQ.

New EMA trial transparency policy may mean higher legal costs for CROs say campaigners

06-Oct-2014 - The European Medicines Agency (EMA) on Jan. 1 will begin publishing clinical trial reports, which underpin the decision-making on medicines. 

Parexel acquires RTSM service provider ClinIntel

06-Oct-2014 - CRO Parexel International has acquired all of the outstanding equity securities of privately-owned and UK-based ClinIntel, a provider of clinical Randomization and Trial Supply Management (RTSM) services.

EMA urged to make trial data transparency policy crystal clear

02-Oct-2014 - Campaigning group Alltrials has reiterated its call for the EMA to prevent "excessive redaction" and to let researchers print clinical trial data without fear of litigation ahead of the Agency’s...

WuXi expands testing division in US with acquisition of CRO XenoBiotic Laboratories

02-Oct-2014 - China-based WuXi PharmaTech has acquired CRO XenoBiotic Laboratories (XBL) to bolster its bioanalytical and DMPK (Drug Metabolism and Pharmacokinetics)/ADME (absorption, distribution, metabolism, and excretion) services. Financial terms were not disclosed....

Novotech moves into China with new Shanghai office after requests from US and EU customers

01-Oct-2014 - Australia’s largest clinical CRO Novotech has expanded its services into China with a new office in Shanghai.

ex-RPS CIO drops wrongful dismissal lawsuit and allegations the CRO unlawfully stored applicant data

01-Oct-2014 - An ex RPS employee who claimed he was sacked after discovering the CRO was unlawfully storing potential employees’ personal data has settled his lawsuit and withdrawn allegations of wrongdoing.

Chiltern eyes Asian expansion with acquisition of Pacific Clinical Research

30-Sep-2014 - In a sign of further industry consolidation, CRO Chiltern has acquired Pacific Clinical Research, a pan-Asian CRO based in Singapore. Financial terms of the deal were not announced.

LabCorp to acquire NMR-focused, personalized diagnostic company LipoScience for $85m

29-Sep-2014 - CRO LabCorp has entered a definitive agreement to acquire LipoScience for $5.25 per share, or about $85.3m (€67.2m).

PPD increases stake in small molecule discovery company X-Chem citing Big Pharma relationships

29-Sep-2014 - CRO PPD has exercised its option to acquire the remaining minority ownership interest of X-Chem for an undisclosed sum. X-Chem will continue to operate as a small molecule discovery company...

Update

EMA opens investigation into India’s GVK Bio over ECG falsifications

26-Sep-2014 - At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified...

French regulator raises concerns over Indian CRO studies

25-Sep-2014 - Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical...

Researchers highlight why clinical data should be more transparent

25-Sep-2014 - The rarity of medical research reanalysis and the extent to which reanalysis changes the original findings has two physicians calling for more transparency in an editorial in this month’s JAMA ...

ACRO, Dana Farber seek more info on FDA informed consent draft guideline

24-Sep-2014 - More commentary on the US FDA’s informed consent draft guidance is trickling out, this time with ACRO (Association of Clinical Research Organizations) and the Dana Farber Cancer Institute offering their...

Covance, Frenova team to share and analyze data on CKD, renal disease

23-Sep-2014 - CRO Covance and Fresenius subsidiary Frenova Renal Research are collaborating to find more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).

Ukraine still attracting Quintiles, PPD, Icon, Parexel and INC says study

22-Sep-2014 - Political instability in Ukraine has not diminished international drug industry desire to conduct clinical trials there according to a new report.

TransCelerate hones in on two aspects of new risk-based monitoring methodology

22-Sep-2014 - TransCelerate’s new RBM (risk-based monitoring) methodology focuses on the use of technology and centralized monitoring to shift away from Source Data Verification (SDV) to risk-driven monitoring, according to two papers...

Concerns raised over FDA’s informed consent draft guidance

22-Sep-2014 - The US FDA was flooded with comments  on its draft guidance  seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what...

Evotec looks to recover payments from Andromeda over faked Phase III data

18-Sep-2014 - Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.

update

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

17-Sep-2014 - Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in...

Trial transparency: NICE stands firm on data

16-Sep-2014 - The UK’s NICE says it will go over drug companies’ heads and get clinical trial data from regulators if sponsors fail to supply their results.