Collaboration and cross-selling across Syneos Health's clinical and commercial organizations drove a record quarter marked by new strategic relationships as customers look to increase outsourcing in response to pricing pressures.
Lexaira Bioscience says its DehydraTECH platform has demonstrated significant improvements to the bioavailability of cannabinoids, and could be applied to other pharmaceuticals.
PRA Health Sciences’ Q2 revenue is up 35%, as the CRO accelerates integration plans with Symphony Health and predicts an increase in staff towards the end of the year.
The latest regulatory update in the valsartan recall saga comes from the US FDA, which has published Form 483s relating to inspections at Zhejiang Huahai plants in 2016 and 2017.
In a second quarter call with investors, president of Mylan, Rajiv Malik, stated the company has undertaken a restructuring and remediation plan at its Morgantown, West Virginia plant.
Modeling and simulation can provide “meaningful prediction” of a drug’s pharmacodynamic range and maximum dose – the use of which might have prevented the tragic outcome of the BIAL 10-2474 trial in 2016, says Certara VP.
Revenue growth has taken off, driven by steady start-up on several programs, as the CRO remains focused on its core market of small and midsized biopharma – which makes up the majority of its revenue.
Frequency Therapeutics initiates a Phase I/II clinical trial for hearing restoration, using progenitor cell activator technology for the first time in adult patients.
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.
Janssen has confirmed plans to close a supply chain facility in HyangNam, while Bayer is transferring manufacturing operations from Ansung, South Korea, to Berlin, Germany.
Outsourcing-Pharma recently conducted a second ‘state of the industry’ survey to gauge views about the current state of the global pharmaceutical outsourcing market and the evolving relationships of those involved.
TransCelerate and BioCelerate have launched a new data sharing platform to connect preclinical and clinical information to help better inform clinical trials.
LabCorp signed several partnership deals in the second quarter of 2018 as the company aims to enhance the drug development process and continues to invest in its CRO business.
The MHRA has issued guidance outlining how UK pharma would be affected during the Brexit implementation period, due to be finalised in the Withdrawal Agreement come October.
Iqvia recently announced its second quarter 2018 results, which came in “above the high end” of the company’s expectations at $2.567bn, said CEO Ari Bousbib.
Repeal of the hotly debated medical device tax would free up research and development resources and bring clinical trials back to the US, say CRO industry executives.
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.
LEO Pharma acquires Bayer’s prescription dermatology unit in a definitive agreement, in hopes of reaching their goal of being the leading global dermatology company by 2025.
The global market for in vitro toxicity testing is predicted to reach $8.8bn by 2023 – and demand is expected to increase, driven by new technologies and regulations, says Charles River.
Accelovance and Linical merged in March of this year to create a global midsized CRO for which ‘future possibilities are endless,’ says newly appointed CEO.
The FDA guidance addresses EHR data use in clinical trials – and while “one of the most prescriptive in recent memory” – does not solve interoperability challenges or address other sources of data, such as wearables.
The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.
Sanofi has written to the UK’s health secretary and the chief executive of the NHS to inform them that the company is stockpiling drugs ahead of the deadline for Brexit.