FDA grants Orphan Drug Designation for narcolepsy treatment
26 June 2019 | By European Pharmaceutical Review
The FDA has given the XWL-008 compound Orphan Drug Designation for the treatment of narcolepsy.
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Regs & Legs
Manufacturing, Packaging & Logistics In-Depth Focus 2019
26 June 2019 | By European Pharmaceutical Review
Whether by ignorance of the latest best practices, or willful disregard for patient safety, the results of careless practice can often be fatal. The articles in this in-depth focus highlight how regulatory bodies are taking action to raise the industry’s game.
Article: Inorganic elemental impurity mixes according to ICH Q3D guidelines
25 June 2019 | By Merck
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis, or may be present as contaminants, (e.g., through interactions with processing equipment or by being present in components of the drug product) and are consequently detectable in the…
Whitepaper: Implications of the EU Biocidal Products Regulation 528/2012 for cleanroom disinfectants
25 June 2019 | By Contec
Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance with the requirements of the EU Biocidal Products Regulation (BPR) and any relevant national legislation before being placed on the market.
China announces generic drug list to reduce pharmaceutical costs
25 June 2019 | By Victoria Rees (European Pharmaceutical Review)
Chinese government introduces initiative to enable generic drugs to enter market and reduce prices.
Scientific Poster & Whitepaper Gallery 2019
25 June 2019 | By European Pharmaceutical Review
The latest research and developments from Pharma and Biopharma industry experts.
FDA approves treatment for sexual dysfunction in premenopausal women
25 June 2019 | By Victoria Rees (European Pharmaceutical Review)
The FDA has announced its approval of a therapy for hypoactive sexual desire disorder in premenopausal women.
FDA plans to institutionalise drug compounding
25 June 2019 | By Victoria Rees (European Pharmaceutical Review)
The FDA has told its staff that it will be assigning drug compounding to the Office of Compliance.
Premier Pharmacy Labs recalls products after FDA inspection
21 June 2019 | By Victoria Rees (European Pharmaceutical Review)
The company has announced a recall of products which were intended to be sterile after a lack of sterility assurance.
FDA announces new data points to aid generic drug developers
21 June 2019 | By Victoria Rees (European Pharmaceutical Review)
The FDA has released new data points which increase transparency for generic-drug competitors.
Lynparza has been approved for BRCA-mutated advanced ovarian cancer
21 June 2019 | By European Pharmaceutical Review
BRCA-mutated advanced ovarian cancer treatment has been approved by the European Commission.
Four pharmaceutical companies accused of illegal anti-competitive conduct
20 June 2019 | By European Pharmaceutical Review
The CMA has revealed findings that provisionally show that four pharmaceutical companies have broken the law.
European Pharmaceutical Review Issue 3 2019
20 June 2019 | By European Pharmaceutical Review
In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
Type 2 diabetes treatment approved for children and adolescents
18 June 2019 | By Victoria Rees (European Pharmaceutical Review)
The FDA has approved an injection for use in patients aged 10-17 to treat type 2 diabetes.
US Food and Drug Administration sued over Ruzurgi drug approval
17 June 2019 | By European Pharmaceutical Review
Catalyst Pharmaceuticals Inc has sued the FDA to challenge the recent approval of a lower-cost rival drug.
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