FDA Panel Recommends XFG Variant for Fall Covid Shots
Replimune will submit an application to the FDA for the third time. Pfizer and Innovent Biologics reached a collaboration agreement valued at up to $10.5 billion.
medpagetoday.comThe FDA's vaccine advisory panel recommended that fall Covid-19 shots target the XFG variant. Replimune will file a biologics license application with the FDA for the third time after two prior submissions. 5 billion in value.
Replimune plans to submit its application following earlier rejections by the agency. The company has not disclosed the specific product or indication under review.
The companies will work together on multiple drug candidates. 5 billion.
The panel's recommendation covers the composition of vaccines expected to be administered this fall. Health authorities will use the guidance to finalize strain selection for upcoming production.
Key Facts
Potential Impact
- 01
Vaccine manufacturers will adjust production to match the XFG strain.
- 02
Pfizer and Innovent will begin joint research and milestone payments under the new agreement.
- 03
Replimune will incur additional regulatory and development costs for its resubmission.
Transparency Panel
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