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Latest From Francesca Bruce
A new methodology for evaluating the benefits of new medicines aims to make funding decisions more transparent and structured. It could also offer an alternative to the way health technology appraisals reflect value.
Strengthening Brazil’s policy on orphan drugs would help stem the number of court cases brought by patients to access medicines, says Alexion.
Janssen’s commitment to invest more in clinical research in Argentina could be a sign that new regulations are bringing back clinical research to the country.
The BeNeLuxA initiative for improving access to medicines could soon include more countries, but much about the collaboration remains opaque for the pharmaceutical industry. Lawyer Koosje van Lessen Kloeke says constructive dialogue between the initiative and industry would benefit the collaboration.
Sanofi will this week learn whether fexinidazole, the drug the company is developing for sleeping sickness, will be evaluated quickly once it files for approval. The European Medicines Agency’s CHMP is considering this week whether to grant the company’s request for accelerated assessment.
Pharmaceutical industry responses to a consultation by Australia’s Therapeutic Goods Administration on a provisional approval pathway have revealed concerns over whether companies will be able to provide adequate data. Companies have also advised the TGA to look to other regulators, including the European Medicines Agency, for inspiration.