Clinical trials are taking longer, drug development costing more, and the stakeholder group expanding – all compounding to create an "industrywide urgency to streamline how trials are run,” says Veeva VP.
Datavant enters partnership with Prognos to expand the latter’s analytics capabilities to determine clinical outcomes and inform decision making as data availability grows.
Parexel launched a delivery model for its FSP services at DIA 2019 Global Annual Meeting in San Diego as the company aims to tailor solutions for biopharma customers.
ArcheMedX’s new digital platform aims to reduce the risks and costs associated with underperforming clinical trials by analyzing the behavior of project teams and site personnel.
Cobra and Symbiosis announce the completion of their collaboration on viral vector development and manufacturing, supported by £1.9m Innovate UK grant.
Live updates from the DIA Global Annual Meeting 2019 in San Diego as industry leaders from over 50 countries and 400 companies discuss the progress and innovations in drug product development.
Phastar expands globally, adding offices in Japan and the US, and enters a partnership with Medidata to transform its increasing data points into insights.
The value generated by the manufacture of medicines has doubled since 2000, with one of the smallest countries in Europe responsible for a significant proportion of the total figure.
Iqvia today launched a new “patient centered endpoints” solution, which captures the patient experience during clinical trials and real world studies, says SVP.
WuXi Clinical is expanding therapeutically - investing ‘heavily’ in oncology, CNS, GI - and plans to continue growing geographically as well, with a mission to bridge the gap between China and the rest of the world.
Parexel and CluePoints to use CSM solutions for preclinical and clinical risk-based monitoring, after regulatory guidelines impact mutual acceptance of data across the US, EU and Japan.
The share price of BMS sank by over 7% after it stated that it would need to divest Celgene’s Otezla, a blockbuster treatment for psoriasis and psoriatic arthritis.
Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.
Seqens opens new center of excellence that houses R&D capabilities, onsite consulting, and space for coworking and collaboration in Porcheville, France.
CRF Bracket – newly-rebranded as Signant Health – is looking to build momentum around eConsent, rethink the patient’s connection to the supply chain, and build out a stronger analytics platform, says CEO.
The drug discovery, development, and analytical service provider has opened a new facility in Sandwich, UK to support the development and manufacturing of APIs – a market expected to top $270bn by 2026.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
In a bid to increase clinical trial diversity, the FDA published a draft guidance suggesting sponsors rethink exclusion criteria, include children in adult studies when appropriate, use adaptive trials, and make sure other logistical barriers to participation...
The clinical trials marketplace for patient recruitment, SubjectWell, has raised $10m in Series A funding and will further expand its services “into the rest of the English-speaking world,” says CEO.
Analytical software provider and CRO, Cytel, and biostatistics company, Axio Research, merge to deliver analytical solutions for clinical research drug development challenges.
Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.
Transforming statistical data into a surrogate endpoint can enable comprehension of trial results sooner than usual, but few make the cut after formal validation, says drug development expert and DIA panelist.
A new 3D-printed, all-liquid device automates complex chemical reactions on demand – enabling drug screening with limited materials, such as patient biopsies, says researcher.
Females as caregivers, clinical trial participants, and biopharma leaders are among the different roles to be carefully considered as the industry aims for increased inclusion, says BBK executive.
In which areas is artificial intelligence most mature? What are the challenges to widespread adoption? Tufts and DIA recently teamed up to explore these questions.
The US FDA is set to center its drug compounding regulatory program in an office focused on stopping poor quality, unsafe and ineffective drugs reaching patients.
New this year to the discussion at DIA is the conversation around data ownership, as the industry continues to face a deluge of information from more sources than ever.
The Russian all-cargo airline AirBridgeCargo Airlines (ABC) has expanded its SkyCell partnership through which it will lease SkyCell’s containers as sales of temperature-sensitive products boom.
The HIPAA-compliant patient engagement digital platform was developed for clinical trial participants who recently joined or finished a study, providing resources across a range of health conditions.
Zenith-Cognizant Technologies emerges from an acquisition aimed to streamline solutions as more complex “smart factories” become a greater focus in the biopharmaceutical industry.
To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.
A report from the EUIPO demonstrated that a shift in the focus of counterfeited goods to include pharmaceutical products has caused significant loss of sales and employment.
Datacubed Health’s mobile platform has been selected to support a longitudinal Alzheimer’s study aimed at better understanding the disease and finding effective treatments.
