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.
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.
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.
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.
Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
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.
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.
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.
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 Chinese government has released a notice telling medical institutes to comply with the recall of products containing contaminated valsartan and stop using the medicine.
The Russia-based CRO Atlant Clinical has received certification in the organization and management of clinical trials – demand for which continues to increase despite political and economic challenges.
An EMA survey has found that 42% of businesses, with an important step in their regulatory processes occurring in the UK, are not adequately prepared to retain marketing authorisation post-Brexit.
Recipharm has revealed that it will be offering a standalone serialization service to companies that have not yet prepared for the upcoming FMD deadline.
The Croatia-headquartered contract research organization (CRO) has opened its first office in the US and plans to further expand its footprint organically and through potential acquisitions.
The Chinese contract research and development company WuXi AppTec has raised more than $353m in its initial public offering of common stock on the Shanghai Stock Exchange.
Takeda has acquired Shire for approximately $62.11bn (£46bn) to create a Japan-headquartered biopharmaceutical company with a robust pipeline and expanded geographical footprint.
The UK government has provided the “strongest possible reassurance” that it will implement the incoming European Union Clinical Trial Regulation, whatever happens in the Brexit negotiations.
ClinicalRM – which ICON acquired in 2016 – has become ICON Government and Public Health Solutions (GPHS), providing full-service clinical trial execution and functional services to government, NGOs, and commercial customers.
The active ingredient for Nichi-Iko’s diabetic neuropathy drug will be the first of a number of APIs to be supplied from Eisai’s facility in Vizag, India.
Tax policy reforms have made the US and UK attractive locations for drugmaker investment, says PwC’s Jean Delaney, but argued Ireland is “still well positioned on the tax front.”
Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.
The Republic of Ireland will move its population from short-acting to extended half-life haemophilia therapies, under an exclusive two-year deal with Sobi.
Advarra has selected TransPerfect Life Sciences as its strategic supplier of language services, including document translation, digital content localization, and interpretation services.
CTI Clinical Trial and Consulting Services (CTI) has opened a new office in Singapore – a location that will enable the CRO to attract and retain talent as it continues expansion in Asia.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
