Iqvia says its collaboration with Genomics England will help drugmakers and academics draw insights from clinical-genomic datasets – the ‘future of real-world research.’
The online resource organizes and maps myriad sources of research on clinical trial recruitment to help users identify promising interventions, say report authors.
The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased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.
Nanoform specialises in producing APIs in a nanoparticle size range, which the company claims can significantly improve bioavailability and potentially change the fate of an asset in the clinic.
The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.
Following a review of its Ulverston site, GSK announced at the end of last week it would shed positions related to the manufacture of active ingredients for sterile injections.
TriNetX is releasing a series of new tools that will enable more people to conduct health research on their own, with access to rich datasets and analytics, says VP.
Premier Research is expanding its presence in the Asia-Pacific region to include South Korea, Singapore, and Taiwan – with greater health care spending and patient access to new drugs driving demand.
Ahead of the CPhI Worldwide in Madrid next week, Nemaura announced that it would be showcasing its newly developed 48-hour diclofenac transdermal patch and would be linking up with an unnamed global pharma company to develop three new products.
Insmed has become the first company to receive approval through the limited population pathway for antibacterial and antifungal drugs set up by the US FDA in 2016.
As previously reported, researchers have determined that ketamine has potential as a treatment for patients at imminent risk for suicide, and as a therapy for treatment-resistant depression.
With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.
Takeda will become the latest company to base its operations within Massachusetts, after announcing it would leave its Deerfield, Illinois headquarters.
Cytel examines the gap between controlled experiment and real-world data at a time when the industry is collecting more data from more sources than ever before.
Taking inspiration from popular games such as Candy Crush and World of Warcraft, Data Cubed has developed a mHealth platform that promises to increase patient engagement in clinical research.
As Novartis looks to sell a major chunk of its generics portfolio in the US, in-PharmaTechnologist has a look back at some of the stories this year that have signposted larger, on-going trends in the US generics market.
Undisclosed pharmaceutical industry payments to authors of oncology clinical trials published in scientific journals raise concern around credibility and trustworthiness, according to a recent report.
Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
The top three myths of ‘going digital’ relate to the industry’s self-image, the perceived role of technology, and current market conditions – still, digital is not a fad and is here to stay, says industry expert.
Virtrial’s vision is to replace up to half of the standard clinical trial visits with virtual ones, using a hybrid approach incorporating telemedicine.
Hu-manity.co is taking on the human data marketplace with its mission to establish a 31st Human Right: Legal ownership of human data as property – a shift that could help improve clinical research and increase transparency, to begin.
Impel Neuropharma announced the first participant have been dosed in a Phase I trial looking at safety and tolerability for the company’s intranasal olanzapine product.
It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.
Chongqing FDA has published an open letter, apparently from an employee of Fosun Pharma, stating that the firm has fabricated a “large number” of production reports.
Researchers from the Clinic for Special Children have developed a drug delivery catheter system that could reach a larger population of patients receive Biogen’s Spinraza treatment.
Genetic testing could potentially transform the way clinical trials are conducted – but for the patient, the role of the genetic counselor is a key component of this process.
CSL has announced that its full year results saw the company’s net profit increase by 30%, in the same year that it announced plans for a 1.8m-square-foot expansion to its Illinois site.
Apotex had seemed to be having a good week after it received US FDA approval for its generic product, only for it to then be on the receiving end of a warning letter the following day.
Lexaira Bioscience says its DehydraTECH platform has demonstrated significant improvements to the bioavailability of cannabinoids, and could be applied to other pharmaceuticals.
Robotics and automation will help improve the clunky and expensive clinical trial process, says Icon CEO – as the company continues to evaluate potential opportunities to improve efficiency.
Novo Nordisk announced a distribution agreement that will see quats delivered by Signet to the healthcare industry in India, as well as Bangladesh and Sri Lanka.