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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.
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.
Levo Therapeutics has received Fast Track Designation from the FDA for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome.
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.
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
Excipients are integral components of pharmaceutical drug products. Their demand is expected to increase over the next five years owing to their ability to perform various functions such as improving active pharmaceutical ingredient (API) stability, modifying drug release and taste masking. Here, Prateeksha Kaul explores the factors and trends that…
Active pharmaceutical ingredients (APIs) are important compounds used in the manufacture of pharmaceutical drug products. Eric Ciappio discusses the potential of vitamins and n-3 polyunsaturated fatty acids (PUFAs) as APIs, with a focus on their clinical relevance.
New data shows the non-inferiority of efficacy for the subcutaneous (SC) formulation of CT-P13 to the intravenous (IV) formulation of CT-P13 in people with rheumatoid arthritis.
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
The FDA has approved Sandoz's biosimilar Ziextenzo and the company now intends to launch it in the US as soon as possible this year.
Thirteen winners have been announced for the 2019 CPhI Pharma Awards including Dr Ge Li for ‘CEO of the Year’ and a ‘Lifetime Achievement' award for John Chiminski.
A US appeals court has upheld a ruling that threw out a $2.54 billion jury verdict Merck won against Gilead over hepatitis C treatments.
500,000 regimens of Janssen's investigational Ebola vaccine are to be donated to support the Ebola outbreak response in the Democratic Republic of the Congo.
The UK government will invest £3.5 million to help develop new antibitoic treatments for gonorrhoea and make them available to low- and middle-income countries.
One of the most important challenges of the hydrogen peroxide technology has traditionally been the material compatibility.
