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...
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.
Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
British MPs have signed an anti-animal cruelty pledge which scientists warn would “cripple” disease research and outlaw 89% of preclinical animal research.
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.
Sun Pharmaceutical Industries has completed its $4bn (€3.7bn) acquisition of Ranbaxy after receiving the thumbs up from the US Federal Trade Commission (FTC).
Indiana’s new “religious freedom” law is discriminatory and will make it harder to attract the staff needed to develop drugs for cancer and Alzheimer's disease according to Eli Lilly.
Testing the toxicity of drug candidates in animals is archaic and unreliable according to PETA, which joined preclinical CROs at SOT to put forward alternatives.
Global CRO Parexel has signed a definitive agreement to acquire privately-owned, Chandigarh, India-based Quantum Solutions India, a provider of specialized pharmacovigilance services.
As biotech and mid-sized pharma companies continue to drive growth for CROs (contract research organizations), the expected ramping up of prices due to increased competition has yet to fully materialize, experts say.
Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.
Cancer Research UK, the world’s largest charitable funder of cancer research, has selected Medidata’s clinical cloud to support the charity’s drug discovery research.
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’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...
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.
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Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.
Service provider BioClinica will open a Research Triangle Park (RTP) office in North Carolina in response to a rapidly expanding customer base of study sponsors and CROs (contract research organizations) with which it has strategic partnerships.
With a small pipeline of clinical candidates, as well as R&D partnerships with top Big Pharma companies paying for those partnerships, Evotec could be in a position to re-define what it means to be an outsourcing partner.
Ebola, electronic cigarettes and microbiomes are opportunities for the preclinical research sector according to delegates at a US industry conference this week.
The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for controlling the fraudulent products between countries.
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.
Further evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month in a study assessing the diseases’ economic impact.
Rentschler Biotechnologie has increased single-use bioreactor capacity at its manufacturing site in Laupheim, Germany and is moving forward with plans to invest €25m ($27m) in a new stainless steel system in the next few months.
eSource solution provider Clinical Ink is merging with CentrosHealth, a provider of mobile apps for clinical trial patient engagement and electronic patient reported outcomes (ePRO).
The strategic partnership comes with Sanofi providing €250m to Evotec, including €40m upfront, as part of efforts to discover new drug candidates, including in the area of oncology, and specifically at Sanofi’s R&D site in Toulouse, France.
Sigma-Aldrich has signed an exclusive agreement with Roche to distribute its biochemical reagents product portfolio via Sigma’s eCommerce and supply chain capabilities. The companies did not disclose any of the financial details of the deal.
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...
The pharma industry reached a high water mark in 2014 with a record number of new molecular entities approved by the US Food and Drug Administration, especially orphan drugs.