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EMA update: non-EU metformin medicines contain acceptable levels of NDMA
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.
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Technique to manufacture virus-like particle polio vaccines developed
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.
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Statement from the FDA on NDMA found in drugs outside the US
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.
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Environmentally friendly pressurised Metered Dose Inhaler to be developed
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.
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Once-a-month oral contraceptive pill one step closer
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.
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NICE approves new tablet formulation for olaparib drug
The UK NICE has extended its approval for olaparib, updating its formulation from eight capsules twice a day to two tablets twice daily.
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The FDA has approved Exservan™ for the treatment of ALS
The FDA has granted early-action approval to Exservan for the treatment of ALS, which can be administered safely and easily without water.
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EU marketing authorisation granted for rheumatoid arthritis treatment
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.
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Anti-epileptic drug XCOPRI® approved by the FDA
Based on results from two global randomised studies and a large open-label safety study, XCOPRI has been approved by the FDA as a treatment for partial-onset seizures in adults.
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Broadly neutralising antibody to be developed for HIV-1 treatment
The investigational broadly neutralising antibody, N6LS, is to be developed by ViiV Healthcare for the treatment and prevention of HIV-1.
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Ninety-seven percent response rate reported in advanced prostate cancer treatment study
A Phase III study of oral relugolix has met its primary efficacy endpoint in men with advanced prostate cancer, supporting a New Drug Application submission to the FDA.
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Scientific poster: How to Automate Water Content Determination in Pharmaceuticals
The water content of pharmaceuticals strongly influences their quality, shelf-life, and stability as well as the release of the active substances. The determination of water content is, therefore, vital in pharmaceutical analysis.
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Fast Track Designation received for Prader-Willi syndrome treatment
Levo Therapeutics has received Fast Track Designation from the FDA for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome.
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Thermodynamic probes of cold instability: application to therapeutic proteins
Developing a stable therapeutic protein formulation requires an intimate knowledge of the protein and its physical and chemical properties. In this article, Bernardo Perez-Ramirez and Robert Simler discuss the thermodynamic consequences that low temperature can have on the aggregation tendencies of a protein.
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Therapy approved for patients with sickle cell disease complication
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
