BioIVT will use its new internal cloud-based Quality Management System to manage clinical trial data at all of its locations, following the acquisition of five companies since 2017.
Assay.Works and 2bind are partnering to expand the range of discovery services provided for companies in the pharmaceutical and biotech industry, and academic organizations.
Quotient Sciences, a drug development services organization, will expand its operations with a new early phase formulation development and clinical trial manufacturing facility.
Changes at the state and federal level are paving the way for increased participation in clinical trials by providing patient reimbursement for study-related costs.
Certara is using Hedera’s next-generation distributed ledger technology to help the pharmaceutical industry and other stakeholders to ‘capitalize on the myriad of seemingly insignificant activities.’
CPhI panelists agree that there is going to be significant consolidation in the CDMO space – and express the desire to work with fewer suppliers, the top five of which currently account for 15% of the total market.
A review of ‘disabling and potentially long-lasting side effects’ reported in relation to treatments of fluoroquinolone and quinolone prompted the PRAC recommendation.
The American Renal Associates has initiated an investigative site network to bring clinical research to patients while delivering care – and study management services to CROs and sponsors.
An additional investment at the PCI clinical services’ site brought forth an expansion to support the return of investigational drug products used in clinical trials.
Rexahn Pharmaceuticals will combine its small molecule compound RX-5902 with Merck’s anti-PD-therapy, Keytruda, to evaluate its efficacy in patients with metastatic triple negative breast cancer.
New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.
As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.
The FDA is calling on the digital health industry to innovate and proposing a new Center of Excellence for Digital Health – the timing of which is critical, as the industry is receiving more funding and opportunities than ever before, says industry exec.
The CRO and software provider for small molecule discovery, Cresset, is collaborating with Elixir to create a new platform for efficient drug discovery.
According to the US FDA, a facility inspection revealed operators leaned their heads and torsos over open containers while clearing bottle jams, before restarting the aseptic line.
Oracle is adding goBalto’s clinical trial site selection and activation solutions to the Oracle Health Sciences Cloud – in an aim to deliver ‘the best end-to-end clinical trial experience.’
Evotec AG and Ferring Pharmaceuticals are collaborating to discover and develop new small molecule therapies for the treatment of fertility and gynaecological conditions.
Zimmer Biomet has tapped Apple and created an app to facilitate patient and treatment team connection as part of a clinical study that aims to enroll as many as 10,000 participants.
Hybrid study designs can be advantageous for the generation of real world evidence, providing a potential solution to the challenges presented by observational studies.
Under the collaboration, Cognate will integrate Terumo’s processing tools into its innovation labs and will serve as a technology reference center for Termo’s devices as well as a beta site for new technologies.
Charles River will manage and provide staffing for NIAID’s vivarium and related research model operations to support biomedical research across multiple scientific disciplines.
Almac has opened a new 24,000 square foot building at its location in Durham, NC to meet demand driven by the rise in biological investigational products, says CDMO.
Iqvia says its collaboration with Genomics England will help drugmakers and academics draw insights from clinical-genomic datasets – the ‘future of real-world research.’
Novotech has acquired a CRO to further support its customers’ clinical research programs across different phases and countries in Asia-Pacific – an area in which it has 10 partnership agreements providing access to more than 1.4bn people.
Ajinomoto’s amino acid technologies division announced a 10% price increase across all of its markets due to rising costs of manufacturing and transportation.
The 5,000-square-foot expansion responds to client demand, says president Robert Lee: “The market for services is growing, yet the supply of CMOs interested in taking on these complex drug products is not.”
The online resource organizes and maps myriad sources of research on clinical trial recruitment to help users identify promising interventions, say report authors.
Researchers are using artificial intelligence to catalyze drug discovery and preclinical drug development - improving predictive models to guide efficient design and optimizing multi-drug regimens, as two recent examples.
eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.
