South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.
In response to the UK government’s publication of potential ramifications of a no-deal Brexit, the ABPI responded that the pharma industry needs more details on mitigation strategies.
The pharmaceutical and biotech product development consultancy Boyds acquires Blue Duck Consulting to boost its clinical and medical affairs services offering.
Civica agrees a deal with Exela to secure the supply of sodium bicarbonate injections to distribute through its hospital network due to ‘ongoing shortages’.
The FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.
Incorporating patient insights into clinical trial design has ‘consistently’ shown to improve timelines, though this requires involvement from all stakeholders, including physicians, who on average spend only 17.5 minutes with a patient during a single...
Patients often feel more comfortable sharing their feelings with a device than with a health care provider, found researchers at Janssen, who have developed a new voice technology application for clinical trials.
Javara, Elligo Health Research, and Circuit Clinical are leading ‘a monumental shift’ in how clinical trials are conducted through the ‘integrated research organization’ model, which is taking on traditional approaches challenged by ‘participant scarcity’...
From pilot projects to process changes, the evolution of patient centricity is affecting all aspects of drug development, say industry experts, who share best practices and lessons learned.
After ‘holding its breath’ for nearly half a decade, pharma and health care companies are ready to implement new technology in clinical trials – though data standardization will be key to fully realizing the benefits.
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.