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Scientists at A*STAR's Institute of Medical Biology and Institute of Molecular and Cellular Biology have identified a gene encoding a hormone that could potentially be used as a therapeutic molecule to treat heart diseases. The hormone - which they have chosen to name ELABELA - is only 32 amino-acids long, making it amongst the tiniest proteins made by the human body.
Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread® (tenofovir disoproxil fumarate).
Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced that they have reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase III clinical study with the investigational drug RHUCIN under the Special Protocol Assessment (SPA) process that is intended to support the submission of a Biologics License Application.
Tumours that have low concentrations of oxygen (hypoxia) are resistant to radiotherapy. A drug called nimorazole (a hypoxia radiosensitiser) can improve the outcome of radiotherapy for patients with these types of tumours. However, at the moment there is no way to identify people with tumours that lack oxygen, who need this additional drug treatment, from those that only need radiotherapy.
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