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Coronavirus Notebook: G7 Agree On ‘Clinical Trial Charter’, Regulators Focus On Real World Data

 
• By Ian Schofield

The European Medicines Agency has issued advice on managing thrombosis with thrombocytopenia syndrome (TTS) in people vaccinated with adenovirus vaccines, and Brazil has OKd the import of Sputnik V and Covaxin, albeit with numerous strings attached.

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Collaboration is key to equitable supply of coronavirus vaccines and treatments • Source: Alamy

As the spat continues over a proposed waiver of intellectual property rights on COVID-19 products, last week’s G7 meeting in the UK showed that other, more collaborative approaches could also aid efforts to ensure equitable access to coronavirus vaccines and medicines across the globe.

Following their in-person meeting in Oxford on 3-4 June, G7 health ministers signed up to a new agreement designed to...

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More from Vaccines

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.

Anti-Vaccine Activists Among New US CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.

ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 
• By Bridget Silverman

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

More from Pink Sheet

US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
• By Derrick Gingery

The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.