FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
In its 2022 Q1 earnings report, Sanofi reported major wins in the first quarter of 2022, driven mostly by the success of consumer healthcare (CHC) and Dupixent.
Alexion shared the news that Ultomiris (ravulizumab-cwvz) has been approved by the FDA for commercialization, adding another indication for the precedent-setting drug.
Exogene nets $2 million to propel the development of its AI platform for T-cell receptor discovery and Healome spins out to deploy a ‘pro-healing’ platform with a focus on ocular surface diseases.
AviadoBio is celebrating orphan drug designations from both the U.S. FDA and the European Commission for AVB-101, a gene therapy intended to treat frontotemporal dementia (FTD).
The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.
Bristol Myers Squibb will hear from the FDA on April 28 about Mavacamten, while Supernus, Axsome, Coherus, Hutchmed and Incyte also await the fate of their respective drug candidates.
Ampio shares continue to fall following the company’s announcement that the FDA rejected proposed changes to a Phase III study of its treatment for osteoarthritis of the knee and other joints.
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.