The US FDA has rejected Mallinckrodt Pharmaceuticals’ investigational candidate, stannsoporfin, intended for the treatment of newborns at risk of jaundice.
Preparations for an “unlikely” ‘no deal’ Brexit are underway in the UK, with the government instructing pharmaceutical companies to build their medicine reserves before March 2019.
Harvard Medical School and Brigham Women’s Hospital have selected the Aetion Evidence Platform to further support the REPEAT program and the demand for RWE.
Fusion Antibodies revenue grew 41% in FY2018, and while “pop up consultants” have created new competition, the CRO is differentiating itself by investing in its services and focusing on quality.
The multi-phase collaboration between WuXi AppTec Research Service Division and Cyclica looks to advance polypharmacology in drug discovery using AI-augmented technology.
The Coalition for Epidemic Preparedness Innovations announced a collaboration with IDT Biologika for MERS vaccine development in which IDT will receive up to $36m.
Altasciences is set to acquire SNBL in a deal that looks to bridge the gap between preclinical and proof of concept studies – and provide an average of 25% time savings, says CEO.
An alliance between Kinetiq and Halley Consulting group aims to provide new services to the companies’ clients, from compensation analysis to technology compliance solutions.
Alpha Genesis is exploring blockchain technology applications in its primate research activities – the use of which aims to boost transparency and traceability across several areas of the business.
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Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.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.