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Another Step Forward for African Medicines Agency

 
• By Ian Schofield

Rwanda’s health minister says the new body will play a key role in promoting cooperation and mutual recognition of regulatory decisions by individual agencies across the continent.

Africa_Globe
Africa's new medicines agency will have a coordination and harmonization role • Source: Shutterstock

The creation of the African Medicines Agency drew a step nearer after the African Union signed a “host country” agreement with the government of Rwanda, which this week held a two-day conference in the capital Kigali to help speed the process up.

The agreement is “an important step in getting the work of AMA started,” said the Rwandan Food and Drugs Authority.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Novaxovid And mNexspike Reviewers

 
• By Bridget Silverman

Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines

GLP-1s In Crosshairs As Employers Worry About Health Costs – And Their Own Reliance On Rebates

 
• By Cathy Kelly

Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.

UK Must Pay ‘A Little Bit More, A Little Bit Earlier’ For Gene Therapies – CGT Catapult Chief

 
• By Eliza Slawther

If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.