A proposed prescription drug price cap in the wake of the Turing Pharmaceuticals controversy will lead to reductions in R&D spending and could have a negative knock-on effect for CROs say experts.
Full spectrum CROs are well-positioned to service the growing demand for late-stage observational trials driven by regulatory and patient pressure, says Quintiles.
A Japanese company has filed the first US FDA application for a drug with an embedded sensor which can tell doctors if patients have taken their pills.
Sandoz has joined biosimilar developers calling on the US FDA to provide clear guidance on interchangability just a day after launching Zarxio, its Neupogen (filgrastim) copycat.
Japanese industry group JPMA has opted for cloud-based tech to help it understand why the cost of running a trial in the country varies depending on the site involved.
The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
Covance has announced a contract expansion with one of its existing customers signing a multi-year deal to use the CROs trial optimization tech for lab monitoring.
The Jumpstarting Brain Tumor Drug Development Coalition (JBTDDC) is offering a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials to help in the assessment of whether a new treatment is effective.
CRO (contract research organization) Accelovance has accepted a grant from the government of Wales and will open a new site in Swansea with 70 new employees.
The completion of the Phase II study of Isis Pharmaceuticals’ novel antisense drug, volanesorsen, in treating patients suffering from hypertriglyceridemia included a collaborative effort between Isis and CTMG, which claims to be the world’s first Site...
With a flurry of recent deals tied to Sanofi and a string of other collaborations, Germany’s Evotec is seeing a steep rise in revenues from its contract research division and it expects that growth to continue.
Indian contract testing company Sipra Labs has received a warning letter from the US FDA over issues with the company's validation of test methods and failure to investigate out of specification test results.
CRO Medpace has tripled the size of its Stirling, Scotland office with a new office, also in Stirling, that will allow for growth in data management, biostatistics, quality assurance, regulatory affairs, clinical operations and safety services.
Hamburg, Germany-based Evotec and Sanofi are launching a strategic collaboration in diabetes drug development that could be worth as much as $330m (€303m) for the German company, including €3m upfront.
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.
Mid-size CROs (contract research organizations) are banding together once again, this time with Chiltern on Thursday signing a purchase agreement to acquire Theorem Clinical Research.
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.
The Government of India will now defer EU trade negotiations as part of its effort to support local CRO GVK Biosciences, which was accused of data manipulation by the EMA (European Medicines Agency).
Eli Lilly on Tuesday cut ties with the University of California, San Diego (UCSD) as a legal battle between UCSD and the University of Southern California (USC) continues over the control of a major Alzheimer's disease study.
Nine months since its IPO, a group of shareholders of CRO (contract research organization) INC Research common stock are looking to sell off 8m shares, according to an SEC filing.
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.
Mereo BioPharma Group, a recently-formed specialty biopharma company, has selected CRO (contract research organization) Icon as its sole provider of clinical development services.
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.
CRO Quintiles on Friday announced the pricing of a secondary public offering of 7,000,000 shares of its common stock at a price to the public of $77.85 per share, which is about $1 more per share than what the stock was selling for on Friday.
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...
Contract research organization Charles River Laboratories has extended its initial three-year strategic partnership with AstraZeneca for an additional five years.
Contract research organization INC Research reported 14.2% net service revenue growth in Q2, compared to the same quarter last year, raised future guidance and saw its stock bump up more than 10%.
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.
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.
A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September...
