Fewer investigators cite patient recruitment as a top challenge in a recent report which finds investigators also more willing to participate in future clinical trials if working with a preferred central lab.
The network for clinical and imaging data launches a new ‘Real World Imaging’ offering to complement existing real world evidence – and help overcome the challenges of bias and homogeneity, says CEO.
Mallinckrodt announces a settlement agreement on a lawsuit included in the first federal trial over the opioid crisis, shortly after reaching a deal on a previous investigation.
To meet the needs of increasingly complex clinical trials, and sponsor desire for control and scalability, Covance launches an expanded FSP offering focused on delivering ‘clean data.’
The global CRO Cromsource has opened a new office in Research Triangle Park – home to many current and potential clients – after growing more than 150% over the two years, says COO.
Catalent to invest $9m in the building of an early-stage clinical supply facility in San Diego, due to open in the summer of 2020, to integrate its CDMO business.
Mundipharma signs agreement to progress an antifungal candidate through to commercialization, with the potential for it to become the first approved treatment in 13 years.
Increasingly complex clinical trials are putting pressure on CROs to expand their service offerings in what has been a historically monolithic space – with diagnostics also continuing to play a more important role in the market, says industry expert.
Organizations or individuals desiring change is often the reason for retirements, but the timing is often crucial and so it proved for two major institutions in the UK.
Advarra is set to acquire Forte in a bid to expand its offerings to include an integrated suite of standards-based trial management products and services – a platform for ‘an interconnected clinical research ecosystem,’ says CEO.
Velesco to triple its capacity for non-sterile clinical material manufacturing and consolidate its cGMP capabilities with the purchase of a facility in Wixom, Michigan.
The acquisition of Bioclinica’s clinical research site business extends PPD’s trial enrollment business to five continents, 20 countries, and more than 180 research sites.
The Canadian CRO Everest Clinical Research will receive up to up to $100,000 to support the development of new technology for managing data from clinical research trial sites.
The eClinical solutions provider opens the doors at its new headquarters and expects to reach double-digit headcount growth in 2020 amid industry-wide ‘digital transformation.’
The last month of summer saw several hires, including a lead for Worldwide Clinical Trials’ Japan operations, CEO appointments at CordenPharma and LabConnect, and Altasciences’ new CSO, who joins the company from Syneos.
Freenome’s multiomics platform is being used in a Phase II clinical trial to help identify patients most likely to respond to ADC Therapeutics’ antibody drug conjugate.
Orgenesis is developing a ‘distributed’ processing solution – backed by its point-of-care cell therapy platform and CDMO business – to provide approved cell therapies to patients at a fraction of today’s costs, says company executive.
Arkivum to create an e-archive for Idorsia to store and manage its large amount of data regarding products returned from CROs, after the latter’s separation from Actelion.
908 Devices launches Rebel, a bioprocess analyzer, enabling researchers to conduct their own cell culture media analysis to accelerate process development ‘by weeks’.
Strides acquires the only FDA-approved integrated soft gel capsule manufacturing facility in the US, owned by Micelle, to support its operations in India.
Atelerix to work on the development of gel stabilisation technologies enabling room temperature storage of Rexgenero’s cell therapy candidate, under an Innovate UK grant.
NHS GDE Trust Worcestershire Health and Care collaborates with Clinithink to better manage its clinical data through the latter’s ‘natural language processing’ platform.
After launching its eResearch solution earlier this year, WCG announces a pre-configured version to help smaller clinical trial sites manage research and attract additional opportunities.
US FDA updates Mylan’s ANDA to commercialize a generic of Lilly’s Alimta with a tentative approval, putting the company on course to enter the market in 2022.
The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
Veeva Systems has boosted its capabilities in its Veeva Vault RIM to manage regulatory documents and processes for medical devices and diagnostics manufacturers.
The University of Pennsylvania School of Medicine is partnering with Medable to accelerate patient enrollment for its Light Treatment Effectiveness study.
ARG opens new offices in Warsaw as well as Amsterdam, the new home of the European Medicines Agency, both ‘ideal’ locations among Brexit uncertainty, says CEO.
Australia-based Nucleus Network has acquired an early-phase clinical research organization in the US, which has a broad range of access to specialist patient populations, says CEO.
Enteris enters a licensing agreement with Cara Therapeutics for the ongoing development of the latter’s drug candidate as it continues clinical trials.
The FDA this week released a new draft guidance encouraging the inclusion of male patients in breast cancer clinical trials, the incidence of which has increased approximately 26% over the last 25 years.
Bolstered by manufacturing advancements, the global revenues of the pharmaceutical excipients market are expected to grow at a CAGR of 5.8% in the coming years.
J&J is ordered to pay $572m to the state of Oklahoma, after a court judgement found against the pharmaceutical company for its role in the opioid crisis.
As part of its global network expansion strategy, PCI Pharma Services is investing in a new dedicated clinical facility near Dublin, Ireland, which will provide space for secondary packaging, storage, logistics, and distribution.
