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.
Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.
The CRO market in Asia has “massive implications” as it continues to emerge as a preferred destination for clinical trials – a global market expected to reach $57bn by 2020.
GSK has warned that Donald Trump’s plan to encourage US drug production through import tax hikes must take the global nature of pharma supply chains into account.
Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
Catalent has become the first CDMO to join the PSCI – a voluntary industry initiative focused on the social, environmental and economic impact of the supply chain.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”
UK-based contract manufacturers are benefitting from the weak pound following the country’s referendum in June, but the long-term impact of Brexit is still unknown.
The 315 square meter facility will house more than 30 employees in Warsaw, Poland, where the company contract research organization (CRO) has operated since 2008.
