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.
The Korean project, which began in April 2014, required the Sweden-based CDMO (contract development and manufacturing organization) Recipharm to produce a data matrix code, including serial number, to comply with the regulations that are expected to be...
The average budgeted merit salary increase for 2015 topped out at 4.14%, which is up slightly from 2014’s average of 3.94% and significantly higher than 2014’s actual increase of 3.7%, according to a recent survey of 11 top global CROs (contract research...
The CMO (contract manufacturing organization) industry is ripe for consolidation as the rise in outsourcing continues and clients look to simplify their supply chains, DPx CEO James Mullen told Outsourcing-Pharma.com on Wednesday.
Evotec and Second Genome have agreed to partner in small molecule-based discovery and development activities for the treatment of microbiome-mediated diseases.
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.
More cancer drugs are going to be delivered using nanoparticles according to Frost & Sullivan, which says research breakthroughs are going to drive adoption of such technologies.
Biogen Idec, GlaxoSmithKline, Johnson & Johnson, Lilly and Pfizer have all committed to investing in the $100m venture capital fund, alongside Alzheimer’s Research UK and the UK government.
NSF International has published a new standard and developed an auditing program that can help pharma companies verify regulatory compliance and strengthen safety and quality across their excipient supply chain.
The European pharma market isn’t likely to deliver much growth over the next five years as generic markets commoditize, IMS Health VP Graham Lewis warned participants at the DCAT (Drug, Chemical and Associated Technologies) conference on Monday.
The DEA's mismanagement of the controlled substance API quota system and its poor relationship with the FDA have exacerbated drug shortages according to the US GAO.
Porton Fine Chemicals will buy fellow China-based firm Jiangxi Dongbang Pharmaceutical adding intermediates for antivirals and cholesterol busters to its portfolio.
Despite legal reporting requirements, the vast majority of results from clinical trials are not reported on ClinicalTrials.gov within a year of their ending, according to a new study from the New England Journal of Medicine.
Despite slamming the US FDA for tentatively approving two Ranbaxy ANDAs (abbreviated new drug applications) for the first Nexium and Valcyte generics, US District Judge Beryl Howell said last week the agency can revoke the approvals because of manufacturing...
