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The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
The path to formulation of pharmaceuticals is not always straightforward, especially as products are becoming increasingly complex. Recognising strategies with the greatest advantages and considering all the options available to get the best drugs to market can greatly facilitate drug development and formulation. This article will demonstrate how recombinant albumin…
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
Included in this in-depth focus are features on recombinant albumin as a versatile stabiliser and how nanobots will evolve as an effective drug delivery technique.
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
In this issue are articles that explore the impact of M&As within the life science industry, discuss the security trends for medicinal packaging and investigate genotoxic impurities within pharmaceutical products. Also included are features on nanobot drug delivery systems and Raman as an effective analytical approach.
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.
University of Leeds researchers have discovered a method to produce polio vaccines made from virus-like particles, which is being trialled on a manufacturing platform.
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
A pharmaceutical company has announced its intention to create a pressurised Metered Dose Inhaler that will reduce the carbon footprint of the drug delivery system.
A new slow-release formulation and delivery system for the oral contraceptive pill has shown success in pre-clinical trials and could be taken once a month.
The UK NICE has extended its approval for olaparib, updating its formulation from eight capsules twice a day to two tablets twice daily.
The FDA has granted early-action approval to Exservan for the treatment of ALS, which can be administered safely and easily without water.
Remsima SC™ is the world’s first subcutaneous formulation of infliximab and has been approved in the EU for the treatment of people with rheumatoid arthritis.
