Analytical testing, QC

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’...

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

25-May-2015 By Zachary Brennan

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 studies conducted at CRO GVK Biosciences...

Strike while the ion is hot: Metrion targets demand for cardiac risk testing

19-May-2015 By Gareth Macdonald

Making sure candidate drugs are free of cardiac risks means drug industry demand for ion channel screening expertise is growing according to new CRO, Metrion.

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

15-May-2015 By Zachary Brennan

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 innovations will be adopted the fastest remains to be seen.

QPS adds new in vitro dermatology and transdermal research lab in North Dakota

06-May-2015 By Zachary Brennan

Full-service CRO QPS Holdings has opened its new in vitro dermatology and transdermal research laboratory in Fargo, North Dakota. 

Quintiles opens a new bioanalytical lab in the Netherlands

06-May-2015 By Zachary Brennan

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.

Roundup of CRO partnerships, offerings and other news

04-May-2015 By Zachary Brennan

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 the past week. Here’s a roundup of the latest:

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

01-May-2015 By Zachary Brennan

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 FDA can do to speed drug discovery and development.

Charles River stock falls nearly 10% on soft quarterly results

30-Apr-2015 By Zachary Brennan

Charles River Laboratories saw only slight growth in revenue compared to the same quarter last year, which was driven by its safety assessment and endotoxin and microbial detection businesses, and double-digit revenue increases from mid-tier biotech clients.

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

30-Apr-2015 By Zachary Brennan

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 are “ways to greatly improve clinical trial efficiency,” and cut costs through...

Quintiles acquisitions start to pay off in Q1

30-Apr-2015 By Zachary Brennan

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 company reported in its earnings call on Wednesday.

EBG BIOSIMILARS 2015

Regulators: skip clinical data and extrapolate biosimilar indications

29-Apr-2015 By Fiona BARRY

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

Is there a CRO bubble? Analysts say yes, with caveats

28-Apr-2015 By Zachary Brennan

With sky-high valuations and soaring M&A prices, the question of whether there’s a biotech bubble continues to crop up, though now some analysts are saying this so-called bubble and its inevitable pop may be a cause for concern for CROs (contract...

CNS, oncology, complex trials boost INC Research’s Q1 growth

28-Apr-2015 By Zachary Brennan

CRO INC Research saw its net service revenue increase by 14.5% to $211.5m in Q1, which was considerably higher than analyst expectations and driven by particularly strong growth in trials around CNS (central nervous system), oncology and other complex...

LabCorp sees Q1 revenue rise slightly as Covance growth downgraded for FY15

28-Apr-2015 By Zachary Brennan

Just two months after Covance shareholders signed off on LabCorp acquiring the company, and all seems to be going according to plan, though financial expectations for the rest of the year were slightly lowered by the diagnostics company.

Dispatches from PCT US

TransCelerate CEO, leaders offer update on industry group’s activities

27-Apr-2015 By Zachary Brennan

As 20 of the largest biopharma companies have now joined industry group TransCelerate, the group is beginning to use patient centricity and connectivity to influence the clinical trial environment, CEO Dalvir Gill told attendees at the Partnerships in...

Thermo Fisher to offer clients Horizon's X-MAN cell line tech

24-Apr-2015 By Dan Stanton

Thermo Fisher has added X-MAN cell line services to its biopharma R&D offerings through a supply agreement with Horizon Discovery Group.

Merck 'bio-inks' deal to use Organovo's 3D printed liver for preclinical studies

23-Apr-2015 By Dan Stanton

Merck & Co. has struck a deal with Organovo to use a 3D printed human liver system for toxicology testing as a supplement to in vitro and preclinical animal testing.

CMOs earn €8.4m in EU grants to help scale-up manufacturing of thermo-stable vaccines

20-Apr-2015 By Zachary Brennan

A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.

Sartorius adds biologics testing through acquisition of CRO BioOutsource

17-Apr-2015 By Dan Stanton

Sartorius has expanded its biopharma services to include contract testing by buying CRO BioOutsource.

CRO CTI Clinical expands use of Medidata's cloud-based tools

15-Apr-2015 By Zachary Brennan

Full-service CRO (contract research organization) CTI Clinical Trial and Consulting Services is expanding its use of Medidata’s Clinical Cloud platform to improve operational efficiencies, data accessibility and decision-making processes for its clinical...

Eisai inks R&D Genomics data deal; cuts 25% US jobs

13-Apr-2015 By Dan Stanton

Eisai has inked a deal with a genome analytics firm to aid drug discovery days after announcing it would be cutting 25% of its in-house US workforce.

Update

TransCelerate launches two new initiatives to accelerate clinical trials

10-Apr-2015 By Zachary Brennan

Industry group TransCelerate BioPharma has established two new global initiatives around placebo and standard of care data sharing, and electronic labels for clinical trials – both of which aim to accelerate and enhance trials. 

Lower-cost Latin American market to drive growth for CROs, Frost report finds

08-Apr-2015 By Zachary Brennan

A new Frost & Sullivan report predicts the Latin American clinical research market for CROs (contract research organizations) will grow at a pace of 7.1% through 2019, with larger CROs taking advantage of the market the most.

'Unjustified' ban of GVK-tested drugs has damaged India, says Pharmexcil

08-Apr-2015 By Dan Stanton

The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.

Preclinical consolidation: MSI firm Protea buys CRO vivoPharm

08-Apr-2015 By Dan Stanton

Molecular imaging company Protea Biosciences has acquired CRO vivoPharm in the latest instance of consolidation in the preclinical sector.

Super-sensitive protein measurement assay for CRO Eurofins

07-Apr-2015 By Fiona BARRY

Eurofins Bioanalytical Services has announced it will offer an extra-sensitive immunoassay service for biopharma developers.

Piramal set to sell bioequivalence CRO business to Indoco

02-Apr-2015 By Dan Stanton

Piramal has agreed to sell its clinical research business based in Hyderabad, India to Indoco Remedies which will add bio-equivalence and bio-analytical services to its offerings.

Trial site-CRO relationships improving over time, survey finds

02-Apr-2015 By Zachary Brennan

CROs (contract research organizations) received slightly better overall ratings from investigator sites compared to two years ago, though there are still gaps between how sites view sponsors and CROs, according to the recently unveiled CenterWatch Global...

SCRS partners with PRA Health Sciences, unveils scholarships with INC Research

02-Apr-2015 By Zachary Brennan

The Society for Clinical Research Sites (SCRS), which represents the interests of clinical research sites, has announced a two-year partnership with North Carolina-based CRO PRA Health Sciences, while the group’s work with INC Research has resulted in...

Slow study start-ups tied to local IRB use, expert says

31-Mar-2015 By Zachary Brennan

As CROs (contract research organizations) and sponsors look to shave off time from their clinical trial start-up phase, which is where delays occur most frequently, companies may want to look away from local IRBs (institutional review boards), an expert...

Update

Quintiles, Quest Diagnostics launch JV merging lab services

31-Mar-2015 By Zachary Brennan

With an eye on central labs industry leader LabCorp, Quintiles and Quest Diagnostics are combining their clinical trials lab operations to provide clients with the world’s second-largest option.

PRA Health Sciences launches major early phase expansions

30-Mar-2015 By Zachary Brennan

In another sign that early phase research demand is picking up, North Carolina-based CRO PRA Health Sciences (PRA) is increasing its Phase I clinical footprint in the US and Russia. 

Horizon partners with ArcherDX to meet growing demand in the translational sequencing market

25-Mar-2015 By Zachary Brennan

Research tool supplier Horizon Discovery Group and ArcherDX, a supplier of Next Generation Sequencing (NGS) fusion detection, have signed an Original Equipment Manufacture (OEM) agreement that will see Horizon’s Reference Materials supplied as a standalone...

Parexel audit reports come under scrutiny thanks to Ranbaxy’s FDA lawsuit

25-Mar-2015 By Zachary Brennan

Parexel’s audits of Ranbaxy’s deficient manufacturing operations in India were of specific interest to the FDA, though the CRO did not turn over the reports because of concerns that their release might damage the confidentiality of the company’s audit...

Nottingham’s CRO forest thriving: UK Contractors tout new collaboration model

25-Mar-2015 By Gareth Macdonald

Some drug industry sponsors shy away from “jack of all trades” contractors according to a recently formed UK CRO network which says smaller firms with specific expertise can win market share.

Icon funds new research on informed consent at Carnegie Mellon

23-Mar-2015 By Zachary Brennan

Dublin-based CRO Icon is sponsoring a series of research projects at Carnegie Mellon University as part of a long-term partnership to find new ways to improve the comprehension and retention of informed consent documents by clinical trial participants. 

ImmunoCellular taps PharmaCell to manufacture dendritic cell-based vaccine for trial

19-Mar-2015 By Zachary Brennan

European CMO PharmaCell B.V. has finalized an agreement with ImmunoCellular Therapeutics to support its pivotal phase III clinical trial in Europe with ICT-107, a dendritic cell-based vaccine in development for glioblastoma multiforme, a form of brain...

Evotec, Second Genome to collaborate on finding treatments for microbiome-mediated diseases

18-Mar-2015 By Zachary Brennan

Evotec and Second Genome have agreed to partner in small molecule-based discovery and development activities for the treatment of microbiome-mediated diseases. 

Harvard-MIT institute partners with Google-backed Calico to study aging-related diseases

18-Mar-2015 By Zachary Brennan

The Broad Institute of MIT and Harvard has entered into a partnership with Calico to study the biology and genetics of aging as part of early-stage drug discovery efforts. 

Altasciences allies with nonclinical service org to offer more complete early development tools

10-Mar-2015 By Zachary Brennan

Early phase clinical research service provider Altasciences is forming a strategic alliance with ITR Laboratories, a nonclinical services organization, to help more mutual clients customize their drug development programs from lead candidate selection...

Patheon focuses on solubility with acquisition of Oregon-based CDMO

09-Mar-2015 By Zachary Brennan

For the second time in just over a week, CDMO Patheon has made an acquisition, this time for Agere Pharmaceuticals, a privately held CDMO based in Bend, Oregon, that specializes in improving the bioavailability of drugs.

Rho offers support for NIH trial on peanut allergies

04-Mar-2015 By Zachary Brennan

CRO (Contract Research Organization) Rho collaborated with the NIH (National Institutes of Health) on its most recent study that found a major reduction of peanut allergies in children who began early, continuous consumption of peanuts.

Japanese companies acquire CMO KBI Biopharma

26-Feb-2015 By Zachary Brennan

Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and...

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

25-Feb-2015 By Zachary Brennan

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.

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

24-Feb-2015 By Zachary Brennan

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 in a conference call last week.

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

23-Feb-2015 By Zachary Brennan

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 discovery and biomanufacturing. 

Covance shareholders sign off on LabCorp merger

19-Feb-2015 By Zachary Brennan

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. 

SGS rolls out latest Ph.Eur. amino acid impurities testing method at German lab

18-Feb-2015 By Gareth Macdonald

SGS will soon be able to test up to 30 batches of amino acids for impurities per month after adding new analytical methods to those offered at its laboratory in Taunusstein, Germany.

Theorem to boost service offering with CRO partnership

18-Feb-2015 By Zachary Brennan

CRO Theorem Clinical Research and service provider Biomedical Systems have formed a strategic partnership to expand the type of services available to their clients worldwide.