FDA hands Boehringer and Lilly complete response letter for insulin adjunct
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
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Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
Specially designed for R&D laboratories, Telstar's LyoQuest Arctic is a bench-top environmentally friendly lab freeze dryer. Unlike conventional freeze dryers using HFC cooling gases, the Lyoquest Arctic reduces the GWP impact more than 1,000-fold.
A Phase Ib trial for the study of the oral formulation for Amphotericin B has met its primary endpoints, demonstrating safety in patients.
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
European Pharmaceutical Review brings you the latest updates from regulatory bodies across the globe in response to the COVID-19 coronavirus.
A Class 4 falsified medicines directive (FMD) has been issued by the MHRA because medicines may have left the legal supply chain to be reintroduced later through HMS Wholesale Limited.
The producers of hydroxychloroquine have stated they will donate 130 million doses if the drug is approved as a treatment for the COVID-19 coronavirus.
The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.
Hospitalised patients in the UK will inhale the interferon beta 1a (IFN-β) formulation or a placebo to see if SNG001 is effective against the COVID-19 coronavirus.
In 2014, medicines were stolen from Italian hospitals and resold across Europe. The authors of a new report highlight the flaws in regulations that handed the perpetrators insufficient sanctions and explain why MEDICRIME provides a better regulatory framework.
Operation Pangea has revealed a large number of falsified coronavirus treatments, while the MHRA has seized 871,616 doses of other unlicensed medicines.
Esmya (ulipristal acetate)'s licence has been suspended due to the risk of serious liver injury, says the UK government.
The EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.
The EMA has urged that the research community prioritise large randomised controlled studies for COVID-19 treatments and vaccines.
A growing requirement for drugs to be safe and effective is being driven by public awareness and understanding. Nilesh Londhe discusses why this pharmacovigilance is increasing.