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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

More from Pink Sheet

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 
• By Neena Brizmohun

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.