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.
Recent changes in legislation are likely to increase the presence of foreign CMOs in China, says newly formed fill/finish firm Wuxi Griffin Pharmaceutical.
Aurobindo Pharma Limited has denied rumours it is interested in Orchid Pharma after a report suggested it is vying with Dr Reddy’s to acquire the bankrupt API firm.
By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.
Identifying dangerous medicines will take months longer if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.
UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.
Slovakian contract manufacturer Saneca says the opportunity to tap the Russian market is huge despite protectionist policies and changing GMP inspection requirements.
Roche, Merck and Lilly are among those calling for regulatory harmonisation and free movement of goods between the EU and the UK once the latter leaves the Union.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
WuXi AppTec’s acquisition of ResearchPoint Global (RPG) follows the release of a new guideline that will enable Chinese companies to accept clinical trial data from other countries.
Antimalarial drug resistance in Southeast Asia is threatening the control and elimination of malaria, and drug makers can help, says a tropical medicine expert.
AstraZeneca has said it will wait to see how Brexit negotiations progress before deciding whether to make mid-to-large scale manufacturing investments in the UK.
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.
Sanofi says it will demolish a pilot plant in Montpellier that has been left idle since its completion in 2011, citing its evolving biologics-focused portfolio.
