FDA
Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
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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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The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.
Makena injection currently remains on the market but is poised to be removed pending the outcome of the meeting. The final decision will be made in the public hearing.
Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.
The FDA recommended additional clinical and statistical data analyses of Vicineum, as well as issues related to the company’s Chemistry, Manufacturing, and Controls.
This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
Merck’s Welireg won FDA approval for adult patients with von Hippel-Lindau disease who require therapy for associated RCC, central nervous system, and hemangioblastomas.
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.
Palovarotene is being developed for the prevention of heterotropic ossification, which is new bone formation in people with fibrodysplasia ossificans progressive.
The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.”