news
Edible security tag for drugs developed to combat counterfeits
Researchers have created a unique edible film to be added onto the surface of drugs which can produce a security key, preventing counterfeits from reaching patients.
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Formulation
news
Fast Track Designation granted to decompensated heart failure treatment
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
news
NICE requests more data on Keytruda for head and neck cancer treatment
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
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FDA approves sNDA for candidiasis treatment in paediatric patients
Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
news
FDA announces one nizatidine and two ranitidine voluntary recalls
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
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Project to investigate environmental impact of pills in Scotland
A new collaborative project has been initiated to identify the impact that pills can have on Scotland's environment from waste water.
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FDA announces new centre to improve compounded drug quality
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
news
Report indicates seasonal influenza vaccine market in Asia will reach $1bn by 2028
A new report indicates that drug launches and new formulations will drive the growth of the seasonal influenza vaccine market in China, India and Japan from $914m in 2018 to $1.05bn in 2028.
whitepaper
Whitepaper: Complex Generic APIs: A Primer
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.
article
Formulation confidence with recombinant albumin: the benefits of a versatile stabiliser for challenging formulations
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…
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EPR’s news round-up 2019: the stories that defined the year
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
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Formulation, Development & Delivery In-Depth Focus 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.
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ICH M9: biopharmaceutics classification system-based biowaivers
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…
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European Pharmaceutical Review Issue 6 2019
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.
news
Regulatory submissions made for dispersible formulation of dolutegravir
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
