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.
Cognate BioServices closes a round of growth capital from EW Healthcare Partners to secure its capabilities for the commercialization of advanced cellular therapies.
Harbour BioMed has selected PPD as its preferred CRO partner as part of a strategic collaboration to develop novel oncology and immunology therapeutics.
As the industry focuses on modernizing clinical research, Thread is set to continue expanding its virtual research platform after today announcing its acquisition by strategic investors, says company executive.
Researchers develop organ-on-an-electronic-chip platform to explore the electrophysiology of iPSC-derived cardiomyocytes and understand how the heart communicates.
Themis obtains an exclusive licence from Merck to develop vaccine candidates with an undisclosed indication, using its measles virus vector-based platform.
A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
Genentech enters a manufacturing and development agreement with Enable Injections to advance the latter’s patient-administered subcutaneous drug delivery system.
The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
As summer heated up, the pharmaceutical industry saw major developments in preclinical models from new software to 3D-printed tissue, all in the name of drug development.
High prevalence of skin disease and diabetes to boost the global revenues of the topical drug delivery market, with uptake in China and India boosting growth.
