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After Zydus' Historic COVID-19 DNA Vaccine Approval, Inovio To Enter Phase III

Will Data Availability Hold Key To Acceptance?

 
• By Vibha Ravi

Soon after Zydus Cadila won a historic accelerated approval in India for the world’s first plasmid DNA vaccine for human use, in this case against COVID-19, Inovio’s candidate is set to move to Phase III in Brazil. But will the new technology find wide acceptance?

DNA strand
Zydus Cadila Receives Approval For First Human Use Plasmid DNA Vaccine • Source: Alamy

An accelerated approval for Zydus Cadila’s COVID-19 vaccine from India's regulator has given the company global bragging rights to the first plasmid DNA vaccine for use in humans. Zy-CoV-D also becomes the first coronavirus vaccine to be given a nod for use in adolescents aged from 12 to 18 in India.

Surely that’s good press and something the Indian firm can rightfully list as a significant achievement, but Zydus Cadila will still have to construct an effective strategy to get

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More from Approvals

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

More from Product Reviews

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.