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The company is conducting analyses to understand safety data that had been gathered prior to the pausing of the three studies, NCT04605159, NCT04980391 and NCT05229068.
That’s the advice for emerging growth life sciences companies in 2022, according to attorney Frank Rahmani, partner in the global life science and capital markets practice group at Sidley Austin LLP.
The FDA said that the shared NDA documents did not show ample proof that bardoxolone methyl effectively slows down kidney function loss in patients with Alport syndrome.
The decision was intended to resolve the matter as swiftly as possible so that those who claimed to have been harmed by the product could receive expeditious compensation.
It is unknown whether tightening economic sanctions will limit Russia’s ability to ship its vaccines to areas that do not have strong manufacturing capabilities.
With nipocalimab, Janssen is hoping to take one big swing and knock the power right out of these autoantibodies.
The Centers for Disease Control and Prevention (CDC) revised its recommendations on wearing masks indoors to protect against COVID-19.
Chicago-based AbbVie has been making major decisions with company-wide impacts. The therapeutic company appears to be making changes that will benefit its bottom line.
The latest EUA adjustment was based on findings that Evusheld might not be as active against certain subvariants of Omicron, but it could be if the dosage is increased.
The FDA places holds, companies receive clearance for new studies and Pharma giants release new data in last week’s clinical trial news.
Three genome editing companies, Intellia Therapeutics, Editas Medicine and uniQure, are each anticipating a bright 2022 as the promises of gene therapy continue to be realized.
Eli Lilly’s Jardiance scores expanded heart failure approval from the FDA and will now be available to all patients with heart failure to reduce the risk of death and hospitalization.