The FDA held a virtual public meeting yesterday to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA), the agency’s agreement with regulated industry on reauthorizing…
A federal judge has ruled that HHS acted incorrectly in warning drugmakers that ending discounts via the 340B Drug Price Program would constitute a violation of the law. Source: Drug…
The incidence of brain blood clots in one healthcare system increased by almost four times after introduction of the Johnson & Johnson (J&J) COVID-19 vaccine, according to data published in…
Merck has inked a deal worth more than $525 million with preclinical biotech Synthekine to develop and commercialize novel cytokine therapeutics that focus on autoimmune diseases. Source: Drug Industry Daily
Johnson & Johnson (J&J) has settled “substantially all” of the thousands of Risperdal (risperidone)-related lawsuits filed in the U.S. — which had alleged that the company’s anti-psychotic drug caused males…
The FDA is taking more time to review Moderna’s COVID-19 vaccine in adolescents age 12 to 17 years over concerns the messenger RNA (mRNA)-based shot may be associated with increased…
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Source: Drug Industry Daily
Since President Biden abandoned any provisions seeking to reduce prescription drug prices in the approximately $1.75 trillion Build Back Better bill framework unveiled last week, Democratic lawmakers have been trying…
Cortexyme isn’t letting a missed primary endpoint stifle its conviction that P. gingivalis, the bacteria that causes periodontal disease, is a root cause of Alzheimer’s disease (AD) and that its…
The FDA on Friday granted an updated Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine for use in children ages five to 11 years — following a thumbs up…