Analytical testing, QC

Crown Bioscience nabs PDX models, service ops of Molecular Response

17-Feb-2015 By Zachary Brennan

Preclinical CRO Crown is acquiring all of Molecular Response’s existing PDX (patient-derived xenograft) models as well as 8,000 viable human tumors for model development.

More US FDA draft guidance for compounders

16-Feb-2015 By Gareth Macdonald

The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.

Charles River ‘hot in pursuit’ of discovery company acquisitions

16-Feb-2015 By Zachary Brennan

Charles River Laboratories is nearing the acquisition of an early-stage drug discovery company, CEO James Foster told attendees at the Leerink Swann Global Healthcare Conference last week.

inVentiv ups early phase offering with new clinic in Miami

16-Feb-2015 By Zachary Brennan

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.

Icon, PPD expand further into Ireland with more jobs, warehousing space

30-Jan-2015 By Zachary Brennan

While Icon is adding 200 new jobs at a new innovation center in Ireland, PPD is looking to double its packaging warehousing capabilities and quadruple its distribution services on the island.

CRO Simbec-Orion lands Phase III lupus trial with fast-tracked compound

23-Jan-2015 By Zachary Brennan

ImmuPharma and the recently formed CRO Simbec-Orion Group have entered into a collaboration to run a Phase III clinical study of the potential lupus treatment Lupuzor. Financial terms of the agreement were not released.

PPD adds cell-based assay services in Ireland to service EU demand

22-Jan-2015 By Dan Stanton

PPD is expanding its GMP services in Ireland to support regulatory requirements for the growing number of biopharmaceutical drugs in development.

WCCT to work with NIH institute on human flu research

16-Jan-2015 By Zachary Brennan

Southern California-based CRO WCCT Global is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) on influenza research. 

WuXi jumps into genomic analysis, bioinformatics with $65m acquisition

12-Jan-2015 By Zachary Brennan

Chinese service provider WuXi PharmaTech has acquired NextCODE Health, a US and Icelandic genomic analysis and bioinformatics company, for $65m in cash.  

13 primates die at Covance Texas facility due to overheating

23-Dec-2014 By Zachary Brennan

On two separate incidents in September and October, a total of 13 primates died at a Covance research facility in Alice, Texas due to hyperthermia.

Baxter recalls broken saline vials

22-Dec-2014 By Fiona Barry

Baxter has recalled two batches of saline injections after healthcare workers noticed parts of the vial had broken into the product.

Bruker to pay $2.4m to settle SEC charge of improper payments in China

16-Dec-2014 By Gareth Macdonald

Bruker Corp will pay $2.4m to settle US SEC charges that employees improperly funded Chinese officials' sightseeing trips to win analytical tech contracts at state labs.

From CPHI India 2014

Indian manufacturing problems spur growth... for testing companies

03-Dec-2014 By Fiona BARRY

SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.

People on the Move

People news: introducing the latest outsourcing appointments

20-Nov-2014 By Fiona Barry

Clinverse, Intertek and inVentiv are among the pharma services companies announcing new staff this week.

Demand for early formulation work to tackle drug target ‘Wild West’

18-Nov-2014 By Fiona Barry

Sponsors are turning to outsourcing earlier for help with bioavailability formulation, say contract research organisations (CROs)

Catalent to tap particle size engineering industry with Micron buy

17-Nov-2014 By Zachary Brennan

Last week CDMO Catalent acquired Micron Technologies, a provider of particle size engineering technologies, with the aim of improving its early stage tech offering.

Thermo Scientific issues software update after confirming bug in its bioequivalence data platform

04-Nov-2014 By Dan Stanton

Thermo Fisher Scientific has issued a letter to users of its Kinetica technology software confirming discrepancies in its bioequivalence data.

Sterigenics buys amid speculation PE backer is looking to offload

04-Nov-2014 By Gareth Macdonald

Sterigenics International has bought Italian gamma-ray sterilisation firm Gammarad in a deal that comes amid rumors that private equity owner GTCR is looking to offload the Illinois-based contractor.

WuXi partnership to bring genomic profiling to Chinese clinical trials

27-Oct-2014 By Zachary Brennan

CRO WuXi PharmaTech is collaborating with Foundation Medicine to provide genomic profiling to biopharma companies conducting clinical trials in China.

Phøenix from the flåmes? Swedish firm makes the most of old AZ site

23-Oct-2014 By Fiona Barry

A process development firm founded by ex-AstraZeneca employees says closure of the drugmaker’s Swedish R&D site gave it technical knowhow and former colleagues as customers.

Consultant: Commercial bioequivalence software in need of validation in wake of Thermo Scientific's review

22-Oct-2014 By Dan Stanton

A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.

NEWS FROM CPHI

Polymers make you go faster, greener, say BASF and Colorcon

20-Oct-2014 By Fiona BARRY

BASF, one of the world’s largest chemical companies, has chosen Colorcon to distribute its Kollicoat Immediate Release (IR) tablet coatings.

Thermo Scientific assesses PK/PD analysis tool after study shows bioequivalence data discrepancies

14-Oct-2014 By Dan Stanton

Thermo Scientific is assessing its PK/PD data analysis software after a technical paper found discrepancies in results that may have affected drug approvals.

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

02-Oct-2014 By Zachary Brennan

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....

Chiltern eyes Asian expansion with acquisition of Pacific Clinical Research

30-Sep-2014 By Zachary Brennan

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.

Horizon buys Sage for $48m as BIg Pharma turns to personalised medicines for increased return on investment

29-Sep-2014 By Dan Stanton

Merck KGaA’s acquisition of Sigma-Aldrich is testament to Big Pharma’s growing interest in personalized medicine says Horizon Discovery, which has bought Sage Labs for $48m (€38m).

More acquisitions on the 'Horizon' says UK drug discovery services firm CEO post IPO

24-Sep-2014 By Dan Stanton

Newly public Horizon Discovery Group says it is looking for more acquisitions to become a fully integrated products, services and research provider as revenues soars 35%.

Parexel adds two clinical tech companies to partner program

16-Sep-2014 By Zachary Brennan

CRO (contract research organization) Parexel International has allowed clinical technology companies CRF Health and Clinical Ink to join its Perceptive Partner Program. 

BioLegend purchases Covance’s antibody products, manufacturing business

03-Sep-2014 By Zachary Brennan

Antibody and reagent developer and manufacturer BioLegend on Tuesday acquired Covance’s antibody services unit for an undisclosed sum.

The final frontier: Eurofins set for Next Generation sequencing

18-Aug-2014 By Fiona BARRY

Eurofins Genomics has installed next generation DNA and RNA sequencing systems by Roche and Illumina, citing growing sponsor demand for high throughput services.

NIH toxicology contract renewed for MRIGlobal despite tightening budget

06-Aug-2014 By Dan Stanton

The tightening federal budget is increasing competition between research institutes and academia when it comes to preclinical toxicology testing, according to MRIGlobal.

SGS expands Shanghai lab in response to growing pharma demand

31-Jul-2014 By Dan Stanton

Growing pharma demand in China has led SGS Life Sciences to expand its validation testing and lab service offerings at its Shanghai site.

EMA mulls easing labs' adoption of in vivo batch test alternatives

21-Jul-2014 By Gareth Macdonald

Labs involved in EU-wide assessments of animal-free alternatives to drug quality and batch tests may soon be able leverage their work when seeking clearance to offer such methods as a service.

Catalent looks to cash in with $872m IPO

18-Jul-2014 By Zachary Brennan

With its expected sale of 42.5m shares for $20.50 each, CDMO (contract development and manufacturing organization) Catalent is looking to become a public company.

Waters to open laboratory with Chinese Pharmacopoeia

10-Jul-2014 By Zachary Brennan

Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.

Parexel taps Middle East, North Africa with Atlas acquisition

02-Jul-2014 By Zachary Brennan

CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of clinical research services in Turkey, the Middle East, and North Africa. 

BioOutsource targets biosimilars testing growth with new US lab

01-Jul-2014 By Gareth Macdonald

US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.

Dispatches from BIO 2014

Small biotech experts offer cautious approach to CRO use

26-Jun-2014 By Zachary Brennan

Small biotechs thinking of outsourcing should carefully weigh up the pros and cons say industry experts, who warn that for firms that do contract out clinical development choosing the right CRO is vital.

Phase II, III research to see bulk of increases in outsourcing, survey finds

16-Jun-2014 By Zachary Brennan

Phase II and III research is expected to see the biggest upturn in terms of outsourcing from large and medium-sized pharma, according to a survey from the Life Sciences Strategy Group.

Wuxi looks to biologics, med devices with expansions in Minnesota, China

15-May-2014 By Zachary Brennan

Wuxi PharmaTech has completed an expansion of its materials characterization testing facility in St. Paul, Minnesota, as well as its work on a new biologics biosafety testing facility in Suzhou, China.

Independence Blue Cross selects LabCorp as preferred provider

15-Apr-2014 By Zachary Brennan

US health insurer Independence Blue Cross (IBC) has selected LabCorp to be its preferred provider for outpatient and specialty lab services under a new eight year deal.

EMA requests more stability data for some manufacturing changes

14-Apr-2014 By Zachary Brennan

Drugmakers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to a new EMA (European Medicines Agency) guideline.

Drugmakers start your engines: GSK's Formula One discovery formula

26-Mar-2014 By Gareth Macdonald

GSK has asked Formula One team Mclaren to help it discover drugs, arguing that Big Data expertise from outside the contract research sector can accelerate its efforts to develop new blockbuster meds.

Charles River launches new quality control service for biotech and pharma industry

20-Feb-2014 By Zachary Brennan

CRO Charles River Laboratories launched today a new insourcing/outsourcing option for its clients to improve their quality control.

Pyxant to offer bioanalytical services for DaVita’s clinical trials

18-Feb-2014 By Zachary Brennan

DaVita Clinical Research has formed a pact with Pyxant Labs where Pyxant will provide bioanalytical laboratory services for DCR's early-phase clinical trials.

SGS UK expansion to test biologics transport risks

05-Feb-2014 By Fiona BARRY

SGS Life Science Services has expanded its laboratories in Wokingham, UK with a 7,000-sq ft extension which will house biologics stability and formulation testing.

CIL partners to provide more isotope-labeled proteins to pharma

30-Jan-2014 By Zachary Brennan

Cambridge Isotope Laboratories (CIL) is working with Nexomics Biosciences to provide isotope-labeled proteins to nearly all of the world’s largest pharmaceutical companies.

SGS: California dreaming of bioanalysis domination

21-Jan-2014 By Fiona Barry

SGS will open its first bioanalytic laboratory in North America, hoping to capitalise on the growing Californian biotechnology market.

Sigma-Aldrich launches 'knock-out' way to create liver toxicity assays

21-Jan-2014 By Dan Stanton

Sigma-Aldrich has teamed with Biopredic to produce genetically-modified human liver cell lines and assays it says can cut costs by reducing animal toxicology studies in drug discovery.

A QP for GMP? That is the suggestion: IRCA launches pharma auditor training

16-Jan-2014 By Gareth Macdonald

GMP auditors need a professional qualification similar to QP status according to a group whose new training scheme is designed to create a competency benchmark.