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.
Following stints in Paris and Frankfurt, CPhI Worldwide has again set up in Madrid for three days of insight briefings, biopharmaceutical tracks and networking.
Centogene and Denali entered a strategic collaboration to identify and recruit patients with a gene mutation to be enrolled in a Parkinson’s disease study.
A Swedish company’s combination gel and pump delivery system, Lecigon, has received regulatory approval for the treatment of patients with advanced Parkinson’s disease.
The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased transparency.
The outsourced pharmaceutical services industry is getting out of its comfort zone, leveraging resources and partnership and focusing on how to make improvements – as demand continues to increase, says CRO.
The Aquarius Genesis film coating system is specially designed for continuous manufacturing, but can also be applied to batch processes, says executive.
