New COVID Treatments Face FDA, Commercial Barriers Despite Ongoing Need
Sponsors want more endpoint clarity as current state of government pandemic response, along with scientific and regulatory hurdles, is constraining efforts to refill a shrinking COVID medicine cabinet and could create vulnerabilities for future pandemics.
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Pharmacies Likely To Cease Prescribing COVID-19 Therapeutics With End Of Public Health Emergency
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.
WHO Proposes Regulatory Flexibilities For Testing MAbs Against Infectious Diseases
A draft guideline from the World Health Organization intends to clarify regulatory expectations for the assessment of mAbs used for preventing and treating infectious diseases in health emergencies and to help with international harmonization efforts in this field.
Third Time Lucky As Japan Finally Approves Shionogi’s Oral COVID Antiviral
Shionogi’s once-daily oral COVID-19 antiviral finally gets Japan approval after being considered for the third time by an expert panel, paving the way for public availability of the country’s first such home-grown option in early December.