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AstraZeneca, Janssen, Novavax Likely To Be Next ‘Warp Speed’ Vaccines In Phase III

 
• By Nielsen Hobbs

While AstraZeneca’s adenovirus candidate is expected to use Operation Warp Speed’s platform, its start date remains cloaked; the Janssen and Novavax candidates are expected to enter Phase III in September and October, respectively.

COVID-19 Vaccine. Corona Virus SARS-CoV-2, 2019 nCoV virus destruction. A vaccine against coronavirus disease 2019. Breakthrough in the Creating of a COVID-19 Vaccine.

The announcement of a deal between GlaxoSmithKline plc, Sanofi Pasteur and the US government for development and production of the companies’ coronavirus vaccine candidate may eventually offer a resolution to the pandemic, but more immediately it appears to offer an answer to the question of which sponsors would win the coveted “three-to-five” clinical trial spots in Operation Warp Speed.

Ever since the administration’s effort to accelerate the availability of a coronavirus vaccine was announced in May, the collaboration between...

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More from Vaccines

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 
• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

More from Pink Sheet

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.