Food and Drug Administration (FDA)
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The medication (Narcan nasal spray), should it be approved for use, will be squirted into the nasal passages, ensuring absorption into the body and reversing the overdose effects.
The vaccine candidate ASP3772 generated an antibody response to each of the 24 polysaccharides in its makeup and antibody response to the two conserved pneumococcal proteins.
The data may show the need for one, but vaccine and immunologists are pushing back against Pfizer and BioNTech’s contention that one is necessary now.
Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the Centers for Disease Control and Prevention.
It was based on data from the APOLLO trial showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone.
The company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.
The first nonsteroidal mineralocorticoid receptor antagonist (MRA) is approved for adults with chronic kidney disease associated with type 2 diabetes.
HHS issued their announcement, saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”
Adulhelm’s proposed price tag of $56,000 per patient per year is hardly the most expensive drug on the market, but controversy regarding packaging and pricing continues.
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