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One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations

Inequity created by limiting the mRNA vaccine’s third dose to only those individuals who received a primary series of the same vaccine, as well as resulting operational complexities, warrant consideration of a mix-and-match approach with Moderna and J&J products, CDC advisors say; however, FDA appears most focused on vetting manufacturer-specific data on homologous boosting.

Advisory Committees Coronavirus COVID-19

Pfizer COVID Booster Recommendations From CDC Panel Narrower Than FDA's EUA

Advisory Committee on Immunization Practices fails to pass an interim recommendation endorsing third dose of vaccine in health care workers and others at risk of occupational or institutional exposure, with panelists raising concern that the target population was overly broad.

Coronavirus COVID-19 Vaccines

Cidara Aims For Treatment, Prophylaxis Claims For Novel Antifungal

Biotech says rezafungin should best existing echinocandin agents in treatment of Candida pathogen infections, while also offering needed prophylaxis improvements for leukemia and lymphoma patients.

Research & Development Business Strategies

Theravance To Slash Headcount By 75% After Latest Clinical Trial Setback

The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.

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