Analytical testing, QC

iCardiac acquires clinical trials division of nSpire Health

07-Aug-2015 By Zachary Brennan

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.

Parexel looks to accelerate margin growth with low-cost labor

07-Aug-2015 By Zachary Brennan

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 -- to increase its margins.

US FDA to review new drug application using Catalent softgel drug delivery tech

05-Aug-2015 By Zachary Brennan

The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel technology as its delivery platform.

AMRI acquisitions driving up contract revenue in Q2

05-Aug-2015 By Zachary Brennan

With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio, two Aptuit facilities and a UK aseptic facility pay off.

TxCell: we’ll continue to use CMO even after we get back our GMP

04-Aug-2015 By Fiona BARRY

French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.

Australia looks to speed clinical trial start-up times

04-Aug-2015 By Zachary Brennan

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 reduce delays in trial commencement.

China’s FDA calls for verification data on clinical trials

03-Aug-2015 By Zachary Brennan

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 By Zachary Brennan

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 year, according to a North Carolina WARN report...

Growth in biopharma industry buttressing Quintiles’ quarterly earnings

30-Jul-2015 By Zachary Brennan

Consistent Q2 growth for the world’s largest CRO (contract research organization) Quintiles was driven by a spike in the company’s Integrated Healthcare Services (IHS) segment.

Covance acquisition begins paying off for LabCorp in Q2

30-Jul-2015 By Zachary Brennan

LabCorp revealed a more than 46% increase in quarterly revenue from the same quarter last year as the recent $6.2bn acquisition of Covance brought in $620.8m of the overall company’s $2.2bn in Q2.

Icon puts up record net new business wins in Q2

29-Jul-2015 By Zachary Brennan

CRO (contract research organization) Icon reported its highest level of quarterly bookings ever on Tuesday and the company’s stock jumped by about 15%. 

PRA acquires small clinical development software company for $2.5m

29-Jul-2015 By Zachary Brennan

CRO (contract research organization) PRA Health Sciences reported in its earnings call on Tuesday that earlier in Q2 it acquired Value Health Solutions (VHS), a clinical development software company, for $2.5m.

LabCorp’s Covance expands clinical research unit in Texas

28-Jul-2015 By Zachary Brennan

LabCorp’s Covance Drug Development has relocated its clinical research unit (CRU) in Dallas, TX, to a new facility with 28 more medical beds. 

Biologic services demand pushes BioOutsource to open new Glasgow facility

28-Jul-2015 By Zachary Brennan

A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.

Indian government task force calls to simplify clinical trial approval process

28-Jul-2015 By Zachary Brennan

As the number of approved clinical trials in India continues to taper off compared to years past, a government task force is now calling for a new expedited trial approval process.

Source BioScience to boost stability testing services through $10m acq

27-Jul-2015 By Dan Stanton

DNA sequencing firm Source BioScience will bolster its stability testing and storage services through a proposed acquisition of Select Pharma Laboratories.

Thermo Fisher partners with CDC to aid public health labs

21-Jul-2015 By Zachary Brennan

Thermo Fisher Scientific has developed new software via a partnership with the Special Bacteriology Reference Laboratory at the CDC (Centers for Disease Control and Prevention) that helps public health labs to more quickly identify microbial pathogens...

CRO Frontage acquires minority stake in BDM Consulting

17-Jul-2015 By Zachary Brennan

Full-service CRO (contract research organization) Frontage Laboratories has acquired a 45% stake in BDM Consulting to expand its offerings in biostatistics, data management and SAS (statistical analysis system) programming.

AB Science hit with FDA warning letter over clinical trials

16-Jul-2015 By Zachary Brennan

France’s AB Science has received a warning letter from the US FDA for its failure to adhere to agency regulations and to protect trial subjects’ safety in a pancreatic cancer study and GIST (gastrointestinal stromal tumor) studies from 2009 to 2013.

Data management, SOP deficiencies cited often after 2014 GCP inspections, EMA report finds

16-Jul-2015 By Zachary Brennan

The latest EMA (European Medicines Agency) report on GCP (good clinical practice) inspections reveals that deficiencies around SOPs (standard operating procedures), sponsor monitoring, data management, and essential documents linked to trials were most...

Icon’s lab services group partners with Cancer Genetics on range of testing services

14-Jul-2015 By Zachary Brennan

DNA-based diagnostics company Cancer Genetics has partnered with the lab services group of CRO Icon to provide clients with new offerings, including oncology-focused genomic testing, central lab analysis, project and data management, and sample logistics.

Catalent hit with FDA Form 483 at North Carolina plant

13-Jul-2015 By Zachary Brennan

Following an FDA inspection in March, Catalent’s Center of Excellence for Analytical Services in Morrisville, NC was hit with a Form 483 with six observations.

Beast of bio-burden: Charles River to buy bacterial test firm Celsis

09-Jul-2015 By Fiona BARRY

Charles River is set to buy QC company Celsis in a $212m deal to expand its Endotoxin and Microbial Detection business.

Private CRO expands into Armenia

09-Jul-2015 By Zachary Brennan

US and China-based CRO FMD K&L has expanded into Armenia with a new office to support clients’ needs in the region and grow the company’s business further in Europe.  

Epic Sciences expands partnership with LabCorp’s Covance in Asia

09-Jul-2015 By Zachary Brennan

Epic and LabCorp’s Covance have agreed to extend their partnership to provide circulating tumor cell (CTC) technology and oncology clinical trial support in Asia. 

Small molecule chromatography demand driving expansion, says services firm

02-Jul-2015 By Fiona BARRY

UK firm Reach Separations is doubling its lab space as pharma companies call for more chromatography services.

eCRO Bracket Global acquires trial tech provider Clintara

29-Jun-2015 By Zachary Brennan

Bracket Global has acquired Boston-based Clintara, which will allow Bracket to integrate the Clintara platform of trial surveillance tools into its electronic platform for Clinical Outcome Assessments (eCOA). 

TxCell to enhance operator training and sterilisation measures at cell therapy pilot plant

26-Jun-2015 By Gareth Macdonald

TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.

Dispatches from DIA

An evolution: B-MS, Celgene offer early insights into RBM

24-Jun-2015 By Zachary Brennan

Two early adopters of RBM (risk-based monitoring) – Bristol-Myers Squibb and Celgene – have provided details into the way they’re reducing clinical trial site visits to increase efficiencies around identifying risks earlier and more efficiently.

Eurofins to buy Biomnis for €220m in latest diagnostics sector deal

22-Jun-2015 By Gareth Macdonald

Eurofins Scientific has announced plans to buy French testing services firm Biomnis in what would be its third investment in the diagnostics space this month.

INC launches first SAG to drive earlier insights to protocol development of CNS studies

12-Jun-2015 By Zachary Brennan

CRO INC Research has launched the industry’s first Site Advocacy Group (SAG), which will initially focus on central nervous system (CNS) protocols.

Organovo on track for 3D bio-printed kidney tissue model

11-Jun-2015 By Dan Stanton

Organovo is looking to bring its 3D bioprinted kidney tissues to market in September 2016 following the launch of its preclinical Human Liver system.

Harvard professors question aspects of 21st Century Cures Act

09-Jun-2015 By Zachary Brennan

The 21st Century Cures Act may actually offer the FDA too much discretion to approve drugs without conventional clinical trials, and in some cases “on the basis of less rigorous data,” two medicine professors from Harvard write in an editorial in the...

Accuratus growing CDMO biz through Array Biopharma's CMC operations

09-Jun-2015 By Dan Stanton

Accuratus Lab Services has bought the chemistry, manufacturing and controls (CMC) operations of Array BioPharma to boost its CDMO offering.

Unchained Labs ups its biologics stability toolset with Avia acquisition

08-Jun-2015 By Dan Stanton

Unchained Labs has acquired Avia Biosystems and its characterization tool, the Isothermal Chemical Denaturation (ICD) system, to support the growing demand for biologics stability testing.

Intertek to open new lab in light of pharma demand for immunochemistry

05-Jun-2015 By Gareth Macdonald

Intertek will open an immunochemistry lab in Manchester, UK to cater for growing demand for specialised analytical services from biologics and biosimilars developers.

Opko Health acquires Bio-Reference Labs for $1.47bn

05-Jun-2015 By Zachary Brennan

Drug and diagnostics company Opko Health will acquire the third largest US-based clinical lab Bio-Reference Laboratories for $1.47bn. 

Profil Institute lands new alliance focused on metabolic disease

04-Jun-2015 By Zachary Brennan

CRO Profil Institute for Clinical Research will collaborate with Denmark-based Gubra ApS, a metabolic preclinical and drug discovery company, to discover and translate into clinical research novel drug targets, compounds and biomarkers addressing metabolic...

Charles River seeing more strategic relationships, CEO says

03-Jun-2015 By Zachary Brennan

As Big Pharma and biotech companies continue to outsource more of their work, one of the leaders in the preclinical and discovery space – Charles River Laboratories – is seeing more strategic relationships with both large and small clients, CEO James...

Inform Genomics selects Icon for multicenter trial after extensive bidding process

03-Jun-2015 By Zachary Brennan

Inform Genomics has selected Icon as its contract research organization (CRO) for the pivotal multicenter study of its Hematopoietic Stem Cell Transplant (HSCT)/Mucositis product candidate. 

AMRI partners with biotech to aid drug discovery efforts at new Buffalo site

02-Jun-2015 By Zachary Brennan

Albany Molecular Research Inc. (AMRI) has signed a three-year collaborative agreement with biotechnology company HarkerBIO to co-market their drug discovery services to clients. 

LabCorp partnership seeks to advance precision medicine in oncology

02-Jun-2015 By Zachary Brennan

LabCorp has partnered with Sysmex to focus on the development of blood-based molecular diagnostic tests to advance precision medicine in oncology. 

Eurofins to buy diagnostic PCR specialist for $50m

01-Jun-2015 By Gareth Macdonald

Eurofins Scientific has agreed to buy diagnostic testing services firm Diatherix Laboratories for $50m (EUR55m).

Bio-Rad entangled in another lawsuit over foreign bribery

01-Jun-2015 By Zachary Brennan

The former general counsel of Bio-Rad Technologies sued the research company in California federal court last week, claiming he was illegally fired in 2013 after he blew the whistle on the company’s bribery in China.

Qiagen launches new bioinformatics platform for clinical testing labs

29-May-2015 By Zachary Brennan

Sample and assay technology provider Qiagen has launched a bioinformatics content and software platform for clinical testing labs to interpret and report on genomic variants identified in next-generation sequencing (NGS). 

Private equity buys French medical diagnostic service provider Labco for €1.2bn

28-May-2015 By Zachary Brennan

European private equity firm Cinven has agreed to acquire a significant majority stake in France’s Labco for €1.2bn ($1.3m).

Akron, Cognate partner to offer more complete manufacturing services for gene therapies

28-May-2015 By Zachary Brennan

The strategic partnership between Baltimore-based CMO Cognate BioServices and Florida-based Akron Biotechnology will offer clients a more complete package of cGMP manufacturing services and regulatory support to develop regenerative medicines and cell-based...

LabCorp outlines near-term goals following Covance integration

27-May-2015 By Zachary Brennan

With the integration of Covance moving along steadily, Dave King, chairman and CEO of LabCorp, told investors last week at the UBS Healthcare Conference that LabCorp is ramping up a series of initiatives that will lead to $300m (€276m) in new revenue...

Intertek opens new drug stability testing facility citing demand and bigger med devices

26-May-2015 By Gareth Macdonald

Intertek has opened a new stability facility citing demand for bespoke drug and device services like abuse potential assessments and stress testing.

CROs look to buttress research models businesses with CRISPR/Cas tech

25-May-2015 By Zachary Brennan

As the largest pharma and tech suppliers – from Novartis to GE Healthcare to Thermo Fisher – begin exploring the world of CRISPR/Cas gene editing technology, contract research organizations are also looking into the new tech to explore ways to help clients’...