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Cancer drug can reactivate HIV
A team of scientists have recently discovered how a new drug called JQ1 which is currently in early-phase human cancer trials, can reactivate latent HIV...
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Formulation
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Metal simplifies synthesis of antibody drugs
Scientists have developed a method to efficiently modify natural antibodies that can deliver drugs to target cells...
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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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Guide to Ingredients
In this guide to ingredients, two leading companies involved in testing and analysis explain how their service offering meets current industry needs...
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FDA evaluates prescription opioid medications approved for children
The FDA has heard from professional groups, including the American Academy of Paediatrics about the use of opioid cough suppressants for children...
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Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs
A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…
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Continuous manufacturing: regulatory and quality assurance challenges
During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
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Venture launched for a novel compound against malaria
A patient trial for KAF156, a next-generation antimalarial compound with the potential to treat drug-resistant strains of the malaria parasite has been launched...
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FDA grants approval of Besponsa for acute lymphoblastic leukaemia
The FDA has approved Besponsa for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia...
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FDA grants two orphan drug designations for HCC
The FDA has granted two orphan drug designations for T cell therapy products for the treatment of hepatocellular carcinoma...
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Issue #4 2017 – Digital Version
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
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Injectable tissue patch may help repair damaged organs
Researchers have developed a technique that lets them use a small needle to inject a repair patch, without the need to open the chest cavity...
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Experimental treatment for Niemann-Pick disease appears safe
An experimental drug has appeared to slow the progression of Niemann-Pick disease type C1...
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NICE approves three quarters of drugs from the Cancer Drugs Fund
NICE has recommended sorafenib to be routinely available for patients on the NHS making it one of the 24 drugs appraised from the CDF...
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Drug approval harmonisation shows savings potential
Researchers have compared the regulatory authorities responsible for approving drugs and medical products to verify their effectiveness and safety...
