Strengthening Africa’s medicines regulatory framework is key to achieving the “bold goal” of having 60% of the continent’s vaccines produced locally by 2040, said Margareth Ndomondo-Sigonda, head of health at the African Union’s development agency, AUDA-NEPAD. But only 7% of African country’s national medicines regulatory agencies (NMRA) have “moderately developed capacity”, and more than 90% […] Continue reading ->
Three years after the launch of its COVID-19 Technology Access Pool (C-TAP) initiative, the World Health Organization (WHO) has secured its first COVID-19 vaccine license from a private pharmaceutical company, the UN health body announced on Tuesday. The agreement with Medigen Vaccine Biologics Corp., a private vaccine manufacturer based in Taiwan, is a welcome but underwhelming […] Continue reading ->
The Medicines Patent Pool (MPP) announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Japanese pharmaceutical company Shinogi’s COVID-19 antiviral treatment in 117 low- and middle-income countries.  Ensitrelvir is an oral antiviral currently only approved in Japan under the country’s emergency regulatory approval system. The drug is being evaluated under a […] Continue reading ->
One of the most intense debates in the pandemic accord negotiations is over how to fast-track the development and equitable rollout of vaccines and medicines, with pharmaceutical companies insisting that any infringement on intellectual property (IP) rights will stifle innovation and that voluntary arrangements are the way forward. A recent event to showcase voluntary licensing […] Continue reading ->
A new “Zero+” version of a proposed World Health Organization pandemic accord being negotiated by member states has dropped previously strong language that conditioned use of public R&D funds to private sector commitments to price transparency and tech transfer of end products, among other measuress. However, the updated draft text, obtained by Health Policy Watch, […] Continue reading ->
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV). The single-shot vaccine intended for use in adults aged 60 or older represents the culmination of six decades of research to protect the world from RSV. With the green light from the FDA on Wednesday, GSK’s Arexvy vaccine […] Continue reading ->