‘Female Viagra’ wins approval from FDA expert panel A drug developed to increase female libido is a step closer to being approved in the United States. …
Pfizer apologises for Lyrica but presses ahead with patent protection strategy Pfizer has apologised to pharmacists and GPs over any extra work or confusion caused by its attempts to protect the second medical use patent of its product Lyrica.…
FDA approves two new drugs for irritable bowel syndrome The US Food and Drug Administration has approved two new treatments for patients with irritable bowel syndrome with diarrhoea.…
PCSK9 inhibitor evolocumab gets green light for European approval The first monoclonal antibody for treating high cholesterol and the first PCSK9 inhibitor is set to launch following a positive opinion from the European Medicines Agency.…
European Medicines Agency tightens conflict of interest rules for its expert advisersEurope’s medicines safety regulator has tightened up its conflict of interest rules for scientific committee members and expert advisers in updated policy guidance.…
First treatment for blind people with rare sleep disorder gets the go-ahead in Europe A drug to treat a rare sleep disorder almost exclusively affecting blind people has been recommended for authorisation by the European Medicines Agency.…
FDA fast tracks ivabradine’s heart failure licence, years after EuropeThe US Food and Drug Administration has granted a licence for the heart failure medication ivabradine, ten years after the drug was first approved in Europe.…
Indian government stands up to EMA over licence suspensionsThe Indian government has come to the defence of GVK Biosciences, the company at the centre of allegations of flawed data used to support the licensing of generic drugs.…
Gates Foundation aims to cut drug registration times by 50% in sub-Saharan Africa by 2018 Speeding up the time it takes to register drugs, vaccines and diagnostics in low and middle income countries is a key strategy for the Bill and Melinda Gates Foundation.…
Medicines regulators set out priorities for next five yearsMedicines regulators across Europe have set out their priorities for the next five years in a proposed strategy now out for consultation.…