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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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Formulation
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Expert View: Reaching for the (lyo) stars – the unmatched development and scale-up platform for freeze drying
This article focuses on how formulation data can be utilised to create optimal freeze-drying cycles for a specific product based on the unique process analytical technology (PAT) tools and technologies available in SP Scientific’s LyoStar™ 3, a leading freeze dryer for cycle development.
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Formulation, Development & Delivery In-Depth Focus 2019
This In-Depth Focus investigates anticancer nanomedicine developments and the future of MALDI imaging for pharmaceutical formulation research.
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European Pharmaceutical Review Issue 4 2019
This issue includes an investigation into the potential for continuous production lines in biopharma, information on new guidance released by China on their regulatory processes and an assessment of the FMD to improve the drug supply chain. Also within the issue are articles on nanomedicine development, monoclonal antibodies and pharmaceutical…
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Cannabinoids in pharma series: cannabinoids on the market today
This series investigates the growing interest from the pharmaceutical industry in cannabinoids. In this first piece, we hear from industry experts about the current situation of the ingredient on the pharmaceutical market.
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The Nagoya Protocol: sharing the benefits of pharmaceutical products and protecting biodiversity
Researchers use the Earth’s biodiversity for pharmaceuticals, but this is under threat due to climate change and habitat destruction. The Nagoya Protocol aims to conserve these resources in a sustainable way.
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Thermally-stable TB vaccine developed using new technique
A new process developed by the University of Bath protects a TB antigen and a novel vaccine adjuvant from heat damage.
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Swine fever in China raises concern over heparin supply for US
The US supply of heparin, an ingredient used in anticoagulant drugs and found in pigs, is under threat due to an outbreak of disease in Chinese herds.
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New model could be used to predict shelf life of drugs
Researchers have developed a model that describes how antibody solutions separate into different phases and could be used to anticipate the stability and shelf-life of drugs.
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China set to begin Phase II HIV vaccine trials
A vaccine containing the DNA of HIV is poised to enter a Phase II trial, making it the first vaccine of its kind to do so.
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Complete response letter given to ALS treatment for API concern
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
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FDA publishes guidance for Inactive Ingredient Database
The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.
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Crystallised drug formulation extends medical device function
A study has shown that crystallising drugs removes localised immune reaction, allowing long-term release of drugs from medical devices.
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Global pharmaceutical filler market set to increase 5.7 percent
The filler market is predicted to increase to US$2 billion by 2024, according to a new report.
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The impact of counterfeit drugs in south and south-east Asia
Substandard and counterfeit drugs can negatively impact the pharmaceutical industry and patients. Here, we investigate counterfeits in south-east Asia and possible solutions.
