Clinical / R&D
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Latest From Research & Development
A novel Swedish payment scheme and transferable exclusivity vouchers for new antimicrobials are among mechanisms being examined by the European Commission for encouraging the development of new drugs to tackle the growing problem of antibiotic resistance.
AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.
Just two of six applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster were successful last month.
The European Medicines Agency has rejected claims that industry fees and allegedly flawed methods of evaluating medicines can lead to problematic development and interpretation of evidence.
The new UK government’s political priorities for the years ahead were laid out in the 19 December Queen’s speech, which inevitably centred around the UK’s departure from the EU next month and the negotiation of a free trade deal with the EU. A rise in NHS spending was promised, and new legislation on the future of medicines regulation is on the horizon.
Cardiovascular outcome trials are driving development in blockbuster SGLT-2 inhibitor and GLP-1 agonist classes to look beyond HbA1c levels to focus on cardiovascular and renal protective effects.
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