WTO

The state of the hunt:

Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
  J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
  Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or authorized vaccines
   
New data show lower efficacy for Pfizer/BioNTech: The…

The state of the hunt:

Pfizer/BioNTech’s vaccine won U.S. FDA Emergency Use Authorization.
  The inactivated vaccine from CNBG’s Beijing subsidiary secured UAE registration.
  Bharat Biotech and SII requested Indian authorization of their respective jabs.

 

Vaccines


Approved or authorized vaccines
 
The Pfizer/BioNTech vaccine extended its regulatory lead this week with new authorizations, including a U.S. nod.
 
The U.S.…

The state of the hunt:

China will join the COVAX Facility, its foreign ministry announced Thursday.
  Regeneron requested U.S. FDA emergency authorization for a monoclonal antibody cocktail, and Eli Lilly planned a similar request for its mAb cocktail in November. 
  Remdesivir showed expanded benefits in final Phase 3 results published in the New England Journal of Medicine.

 

Vaccines

Phase 3 candidates:
 
The European Medicines Agency…

STAT reported this week that Chile is the latest country to challenge Gilead’s patents for hepatitis C treatment after the country’s health minister endorsed a resolution to grant compulsory licenses for the company’s blockbuster sofosbuvir drug based on exclusions in the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS).

In September 2017, Malaysia became the first country to grant a compulsory license to manufacture a generic version of…

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