Boehringer Ingelheim’s China-based CDMO is providing clinical trial materials for CANbridge Life Sciences' Phase Ib/III study of its drug candidate intended to treat esophageal cancer.
The US FDA has granted expiration date extensions for specific lots of Mylan’s EpiPen auto-injectors, as manufacturer Pfizer works to stabilise supply.
Cryoport is supporting a record number of clinical trials driven by rapid growth in regenerative medicine – a space that will continue to grow and outpace the pharmaceutical industry, says CCO.
Sygnature Discovery is adding a new facility at Alderley Park in Cheshire, UK in response to an increasing demand for outsourced preclinical research services.
Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.
Syneos Health has acquired the UK-based advisory firm Kinapse in a deal that will double its consulting footprint in Europe and further strengthen its commercial offerings – one company's fastest-growing lines of business, says CEO.
VIARES’ training program was developed to train entry-level CRAs – a vital role in the clinical research industry for which there has been a significant shortage.
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.
Alnylam received US FDA approval for its first-in-class RNAi treatment, Onpattro, but a spokesperson confirmed manufacturing for the treatment is a complicated affair.
Fueled by increasing investments from biotech, Charles River expects to double the size of its business over the next five years – organically and through M&A – to become a ‘more responsive partner,’ says CEO.
Evotec is conducting preclinical and toxicology/safety studies for Stealth BioTherapeutics’ lead candidate, ahead of clinical trials slated to begin in 2019.
In an update on the implementation of the new Clinical Trials Regulation, the MHRA expresses increased confidence that the UK will exit the EU with a deal – and reaffirms its commitment to align with parts of the legislation “within the UK’s control.”
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.
The UK-based CRO anticipates that its FY19 earnings results will be “significantly behind current market expectations,” due to increasing competition and pricing pressures.
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.
