Ridgeback Biotherapeutics LP
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Latest From Ridgeback Biotherapeutics LP
Paxlovid Gets FDA Panel Backing For Full Approval; Combating Rebound Misperception Urged
Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.
Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval
Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.
EMA Backs Approval For Eight New Drugs But Rejects Lagevrio For COVID-19
Janssen’s Akeega is among the latest drugs that the European Medicines Agency says should be approved for use in the EU. Meanwhile, MSD/Ridgeback Biotherapeutics plan to appeal the agency’s rejection of their COVID-19 treatment.
High-Stakes Meetings With EMA Scheduled For Four EU New Drug Filings
The sponsors of four medicines that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
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