A proof-of-concept study using patient-derived cells to test drug response in clinical trials demonstrates the benefits of precision medicine, movement to which is the future of study design, says researcher.
Idifarma’s seventh project with Palobiofarma will see the CDMO provide drug formulation, development and manufacturing services for respiratory disease candidate PBF-2987.
The FDA’s recent guidance on complex generics ‘increases clarity’ for Indian drugmakers targeting the US market, according to India Ratings and Research.
Icon reported a record number of new business awards in Q3 and outlined its three-part patient recruitment strategy as well as global hiring – and acquiring – plans.
Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.
WuXi Biologics and CANbridge Pharmaceutical have entered into a long-term partnership to develop and commercialize a portfolio of biotherapeutics for rare diseases.
SGS announced it will provide new in vitro toxicology services at its Mississauga, Canada Laboratory following an investment in instruments and laboratory capabilities.
LabCorp sees significant opportunity to grow its Covance Drug Development business in the face of a potentially challenging 2019 and is on track to deliver costs savings as part of its LaunchPad initiatives.
An MHRA audit of Recipharm’s facility in Ashton-under-Lyne has revealed the CDMO was deficient in certain manufacturing procedures for potent products.
Marken is centralizing its brokerage management services in conjunction with UPS, as the rise in global trials brings more vendors and new challenges into the fold.
The India-based CRO Veeda Clinical Research has completed a second audit by the Malaysia Regulatory Agency, following 18 US FDA inspections over the past two years.
Iqvia reported a record quarter of contracted bookings during its third quarter earnings call, as the company continues to invest in its technology platform while securing new customers, say CEO.
Velesco Pharma has expanded its analytical research and development capabilities to meet a growing demand for its services after acquiring a new facility in Michigan.
CROs don’t have sufficient access to clinical research associates (CRAs) to realize market growth, says the CEO of VIARES, which is working to create a new trained and accredited workforce.
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.
