Three more products are now available for use against SARS-CoV-2 infection in Australia after the Therapeutic Goods Administration provisionally approved Novavax, Inc.’s Nuvaxovid vaccine and two COVID-19 treatments: Paxlovid (nirmatrelvir/ritonavir) and Lagevrio (molnupiravir), from Pfizer Inc. and MSD/Ridgeback Biotherapeutics LP respectively.
Coronavirus Notebook: Australia OKs Paxlovid, Lagevrio & Nuvaxovid, New Sputnik Data Show ‘Strong Protection’ Against Omicron
International regulators have broadened their discussions on the possible use of bivalent and multivalent vaccines, and the French presidency of the Council of the EU has called for “international solidarity” on vaccine provision.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.