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.
Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.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.
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.
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.
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.
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.
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.
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.
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 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.
The Republic of Ireland’s pharmaceutical industry has responded to the Brexit Steering Group’s stance on a withdrawal agreement, which insists the deal include a ‘viable backstop’ for its border with Northern Ireland.
The health and life sciences services provider Ashfield Healthcare Communications, part of UDG Healthcare, is set to open in Manchester, marking the firm’s nine office in the UK.
WCG’s acquisition of KMR Group and MCC addresses sponsor and CRO need to establish a common set of metrics to understand and manage clinical trial performance, says CEO.
Researchers have halted a clinical trial testing sildenafil citrate – the active ingredient in Pfizer’s Viagra – in pregnant women, following reports of baby deaths.
UK-headquartered Concept Life Sciences says completing FDA registration means it can test raw pharmaceutical materials and finished products for the US market.
The first ever drug to treat smallpox has been approved by the US FDA, after having been created by SIGA Therapeutics in coordination with several US departments.
The US FDA has joined other national regulatory bodies across the globe in recalling certain valsartan medicines, which were found to contain a probable carcinogen.
